clobetasol and halobetasol

Discordance between patient and clinician treatment goals and expectations can present a challenge to implementation of effective therapeutic plans. Because topical treatments are commonly used for plaque psoriasis, both as monotherapy and adjuncts to other treatment modalities, providers need to understand the concerns of patients with psoriasis regarding use of topical products. Psoriasis is a complex and chronic disease with treatment needs that may change over time, influencing patient treatment goals and expectations of efficacy. When these expectations are not met and patient concerns are unaddressed, dissatisfaction may lead to nonadherence, which in turn can prevent patients from achieving relief from the signs and symptoms of psoriasis that affect their quality of life. Here, we detail how current topical treatments meet patient expectations and needs, with particular attention given to combination regimens using corticosteroids. This review shows that once-daily application of halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) not only has a rapid onset of treatment effect and proven efficacy, but also has a remittive effect. In addition, HP/TAZ has a favorable safety profile, with low rates of irritation and local skin reactions in clinical studies. The dual mechanisms of action related to 2 active ingredients, once-daily use, and the favorable clinical findings suggest that HP/TAZ may address patient concerns and promote treatment adherence.J Drugs Dermatol. 2023;22(2):132-138. doi:10.36849/JDD.7367.

Topics: Clobetasol; Dermatologic Agents; Drug Combinations; Emollients; Emulsions; Humans; Motivation; Nicotinic Acids; Psoriasis; Quality of Life; Severity of Illness Index; Skin Cream; Treatment Outcome

Halobetasol propionate foam has been established as an efficacious and easy-to-use topical treatment for adults with plaque psoriasis. Its recent approval in the United States expanded its use for adolescents from ages 12 to 17 years old.. We briefly summarize the chemistry of halobetasol and review clinical trials involving halobetasol propionate 0.05% foam to evaluate its efficacy and safety profile with a specific focus on adolescents with plaque psoriasis.. Halobetasol propionate 0.05% foam is an effective and cosmetically elegant superpotent topical corticosteroid, with a tolerable safety profile in adolescents. The use of this foam offers another option to address patient-specific needs and preferences, adding to the toolbox of currently available treatments for adolescent psoriasis.

Topics: Adolescent; Adult; Child; Clobetasol; Dermatologic Agents; Double-Blind Method; Glucocorticoids; Humans; Psoriasis; Severity of Illness Index; Treatment Outcome; United States

The use of superpotent topical corticosteroids (TCSs) for the treatment of psoriasis is widely practiced, especially for expedient lesion resolution. However, their continued use in managing this chronic condition is limited because of labelling restrictions, concerns of side effects, and a paucity of data to support long-term management strategies. Halobetasol propionate (HP) is an effective short-term superpotent TCS. A novel HP lotion 0.01% formulation has been developed using a polymeric matrix technology that allows for uniform delivery of optimally sized particles onto the skin surface. The polymeric matrix and emulsion help to keep the skin hydrated and provide more efficient delivery of halobetasol into the epidermis.

Topics: Administration, Cutaneous; Clobetasol; Humans; Psoriasis; Treatment Outcome; Vasoconstrictor Agents

Lichen myxedematosus (LM) is an idiopathic cutaneous mucinosis, commonly described as localized scleromyxedema. In contrast to scleromyxedema, there is typically no systemic involvement. Treatment options are limited and spontaneous resolution has been reported. We present the case of a 66-year-old Hispanic male referred by his primary care physician for evaluation of asymptomatic dark spots on his trunk and extremities present for about one-year. Physical exam revealed smooth, brown hyperpigmented papules coalescing into plaques on the trunk. Multiple well-demarcated oval dark brown plaques measuring 3 cm in size were located on the upper back, peri-umbilical area, bilateral lower extremities, and buttocks. A diagnosis of lichen myxedematosus was made based on histologic features observed in the dermis. There are 5 subtypes of LM: a discrete papular form, acral persistent papular mucinosis, self-healing papular mucinosis, papular mucinosis of infancy, and a pure nodular form. Occasional patients with LM have atypical features or features intermediate between scleromyxedema and localized LM. We present a case of atypical LM with mixed features of the different subtypes. Herein we will review the varied clinical presentations of LM and highlight the distinguishing features of scleromyxedema. J Drugs Dermatol. 2020;19(3): 320-322 doi:10.36849/JDD.2020.4864.

Topics: Administration, Cutaneous; Aged; Back; Clobetasol; Diagnosis, Differential; Humans; Lower Extremity; Male; Scleromyxedema; Vasoconstrictor Agents

Topical corticosteroids (TCS) are the mainstay of psoriasis treatment. Safety concerns may limit use. Combination with tazarotene may optimize efficacy and minimize safety and tolerability concerns.. Investigate safety and efficacy of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis.. Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=418). Subjects randomized (2:1) to HP/TAZ lotion or vehicle once-daily for 8 weeks, 4-week follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in IGA score and 'clear' or 'almost clear'). Safety and treatment emergent AEs evaluated throughout.. HP/TAZ lotion demonstrated statistically significant superiority over vehicle as early as week 2 (P equals 0.002). By week 8, 40.6% of subjects were treatment successes compared with 9.9% on vehicle (P less than 0.001). A third of subjects remained treatment successes post-treatment. HP/TAZ lotion was also superior in reducing psoriasis signs and symptoms, and Body Surface Area (BSA) involvement. Most frequently reported treatment related AEs were contact dermatitis (6.3%), application site pain (2.6%), and pruritus (2.2%).. No data were collected beyond the 4-week follow-up.. HP/TAZ lotion provides synergistic efficacy that is both rapid and sustained, with good tolerability and safety over 8 weeks use. J Drugs Dermatol. 2018;17(8):855-861.

Topics: Clinical Trials, Phase III as Topic; Clobetasol; Dermatitis; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Multicenter Studies as Topic; Nicotinic Acids; Pain; Psoriasis; Randomized Controlled Trials as Topic; Severity of Illness Index; Skin Cream; Treatment Outcome

Superficial cutaneous hemangiomas of infancy represent a therapeutic challenge. Two small case series using ultrapotent topical corticosteroids for periocular hemangiomas were reported in the ophthalmologic literature. The use of this therapy for hemangiomas of infancy at other sites on the body has not been reported.. We sought to assess the clinical effects of short-term application of ultrapotent topical corticosteroids for the treatment of hemangiomas of infancy.. The records of 34 infants with proliferating hemangiomas of infancy that were treated with ultrapotent topical steroids were reviewed retrospectively. Treatment response was based on: (1) cessation of growth; (2) shrinkage or flattening of the lesion; and (3) lightening of the surface color. Lesions demonstrating responses of two of the three criteria were judged to have good response; one criterion, partial response; and no improvement, no response.. Of the patients, 35% demonstrated good response, 38% partial response, and 27% no response.. Hemangiomas in 74% of the infants demonstrated either good or partial response to treatment with ultrapotent topical corticosteroids. Of the responders, the majority reported cessation of growth before what would have been expected for their age. Improvement varied, with thinner superficial hemangiomas demonstrating better cosmetic improvement than thicker lesions.

Topics: Administration, Cutaneous; Betamethasone; Clobetasol; Extremities; Eye Neoplasms; Eyelids; Facial Neoplasms; Female; Hemangioma; Humans; Infant; Infant, Newborn; Male; Retrospective Studies; Skin Neoplasms; Treatment Outcome

Halobetasol propionate (HP) 0.5% ointment and cream are class I topical corticosteroids. We review the efficacy and tolerability of HP for treatment of plaque psoriasis in the English language literature. The efficacy of HP ointment and cream is consistently superior to other super-potent topical corticosteroids. Local adverse events associated with topical HP are similar to those experienced with other super-potent corticosteroids. Combination therapy with calcipotriene (calcipotriol) and tazarotene appears to be superior to monotherapy with topical HP.

Topics: Administration, Topical; Clobetasol; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Male; Maximum Tolerated Dose; Psoriasis; Risk Assessment; Severity of Illness Index; Treatment Outcome

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Breast Diseases; Clobetasol; Female; Glucocorticoids; Humans; Keratosis; Middle Aged; Mometasone Furoate; Nipples; Ointments; Pregnadienediols; Vasoconstrictor Agents

A sequential therapy regimen involving an initial clearing phase of daily applications of calcipotriene 0.005% ointment and halobetasol 0.05% ointment for 2 weeks, followed by halobetasol applied twice daily on weekends and calcipotriene applied twice daily on weekdays, has been shown to be effective in the management of chronic plaque psoriasis. As a clearing regimen, the combined use of halobetasol and calcipotriene for 2 weeks was superior to monotherapy with either agent. Subsequently, the use of halobetasol on weekends and calcipotriene on weekdays allowed 76% of patients to stay in remission for up to 6 months, compared with 40% of patients who applied halobetasol on weekends only and placebo on weekdays. Calcipotriene can be inactivated when mixed with some topical preparations; however, halobetasol propionate 0.05% ointment and cream have been shown to be compatible with calcipotriene for up to 2 weeks. The compatibility of calcipotriene and halobetasol permits the use of these agents together.

Topics: Administration, Topical; Calcitriol; Clinical Trials as Topic; Clobetasol; Dermatologic Agents; Drug Administration Schedule; Drug Therapy, Combination; Humans; Ointments; Psoriasis; Treatment Outcome; Vasoconstrictor Agents

Topics: Calcitriol; Clobetasol; Dermatologic Agents; Goals; Humans; Information Services; Internet; Nurse Practitioners; Patient Care Planning; Primary Health Care; Psoriasis; Quality of Life; Vasoconstrictor Agents

Because physicians from different nations frequently acquire the use of a new medication at different times, the international exchange of experiences with the new medication is valuable in maximizing its efficacy worldwide. In recent years, many new therapeutic agents have been approved for treating psoriasis in the United States. These include the topical agent calcipotriol and the systemic agents acitretin and cyclosporine. In addition to new agents, a new therapeutic paradigm, sequential therapy, has been introduced recently. It is the hope of the authors that by sharing this paradigm and experiences with these agents in the United States, dermatologists in Japan may gain further insight into optimizing the use of these agents in the treatment of psoriasis.

Topics: Acitretin; Calcitriol; Clobetasol; Cyclosporine; Dermatologic Agents; Humans; Photochemotherapy; Psoriasis; United States

Lichen planus is an inflammatory mucocutaneous condition with characteristic violaceous polygonal flat-topped papules and plaques. Pruritus is often severe. Skin lesions may be disfiguring, and involvement of the oral mucosa or genital mucosa in severe cases may be debilitating. Oral lichen planus may predispose to the development of squamous cell carcinoma within lesions. Involvement of the scalp and the nails may also occur. While most cases of lichen planus are idiopathic, some may be caused by the ingestion of certain medications (e.g., gold, antimalarial agents, penicillamine, thiazide diuretics, beta blockers, nonsteroidal anti-inflammatory drugs, quinidine and angiotensin-converting enzyme inhibitors) or linked to hepatitis C virus infection. Patients with localized lichen planus are usually treated with potent topical steroids, while systemic steroids are used to treat patients with generalized lichen planus.

Topics: Acitretin; Anti-Inflammatory Agents; Betamethasone; Clobetasol; Diagnosis, Differential; Humans; Keratolytic Agents; Lichen Planus; Patient Education as Topic; Prednisone; PUVA Therapy; Risk Factors; Teaching Materials

Side effects of topical corticosteroids limit their long-term use. Calcipotriene/calcipotriol (Dovonex/Daivonex) ointment is not associated with any of the side effects of corticosteroids and has been shown to thicken the skin in contrast to the cutaneous atrophy caused by topical steroids.. We attempted to determine whether the addition of calcipotriene to a regimen of topical steroids results in an improved benefit/risk ratio.. Published and unpublished data on combination regimens were reviewed.. In long-term regimens for psoriasis, substituting calcipotriene for topical corticosteroids may result in a steroid-sparing effect. Conversely, topical corticosteroids may suppress the development of local cutaneous irritation that occurs in patients treated with calcipotriene ointment.. Psoriasis regimens combining calcipotriene ointment with superpotent steroids such as halobetasol ointment can result in greater improvement and fewer side effects.

Topics: Administration, Cutaneous; Anti-Inflammatory Agents; Atrophy; Calcitriol; Clobetasol; Dermatitis, Irritant; Dermatologic Agents; Drug Combinations; Drug Interactions; Glucocorticoids; Humans; Irritants; Longitudinal Studies; Ointments; Psoriasis; Risk; Skin

Both halobetasol propionate and clobetasol 17-propionate exerted very marked antiinflammatory, antiproliferative, and vasoconstrictive effects during evaluation in a range of dermatopharmacologic models. Halobetasol propionate was distinctly more potent than clobetasol 17-propionate in the ultraviolet-induced dermatitis inhibition assay in guinea pigs and in the rat model of oxazolone-induced late inflammatory reaction. Halobetasol propionate was slightly more potent than clobetasol 17-propionate in inhibiting croton oil-induced ear edema in rats and mice and in the mouse model of oxazolone-induced early inflammatory reaction. In the cotton-pellet granuloma assay in rats and the epidermal hyperplasia inhibition assay in guinea pigs, halobetasol propionate was distinctly superior to clobetasol 17-propionate. There was a trend in favor of halobetasol propionate in the cutaneous vasoconstriction assay performed in volunteers with ethanol solutions of halobetasol propionate and clobetasol 17-propionate. In a further vasoconstriction assay, performed with a 0.05% concentration of both halobetasol propionate and clobetasol 17-propionate in cream and ointment formulations, halobetasol propionate ointment yielded the highest blanching score. In a hypothalamic-pituitary-adrenal axis study in volunteers, effects of 0.05% halobetasol propionate ointment and 0.05% clobetasol 17-propionate ointment on serum cortisol levels were similar. The overall efficacy trends demonstrated in these dermatopharmacologic studies are in agreement with predictions made from corticosteroid structure and activity relationships and the results of two clinical trials comparing halobetasol propionate and clobetasol 17-propionate ointments in the treatment of plaque psoriasis.

Topics: Animals; Clobetasol; Female; Guinea Pigs; Humans; Male; Mice; Rats; Skin Diseases; Vasoconstrictor Agents

The topical corticosteroid halobetasol propionate (HP) and the retinoid tazarotene (TAZ) are effective in psoriasis treatment. To mitigate adverse cutaneous reactions observed with monotherapy, a fixed- combination HP 0.01%/TAZ 0.045% lotion has been developed for the treatment of plaque psoriasis in adults.. To investigate the long-term safety, efficacy and maintenance of response with HP/TAZ lotion.. This was a 1-year, multicentre, open-label study in 555 adults with psoriasis [Investigator's Global Assessment (IGA) score of 3 ('moderate') or 4 ('severe') and body surface area (BSA) of 3-12% at baseline]. HP/TAZ was administered once daily for 8 weeks and then intermittently as needed in 4-week intervals for up to 1 year based on achievement of treatment success [IGA score of 0 ('clear') or 1 ('almost clear')]. Maximum continuous exposure was 24 weeks.. Of 550 participants with postbaseline safety data, 318 (57.8%) achieved treatment success during the study. Of those, 54.4% achieved treatment success within the first 8 weeks; retreatment was not required for >4 weeks in over half (55.3%), and 6.6% did not require any retreatment. Among participants enrolled for the full 52 weeks, 77.5% maintained BSA ≤5% on treatment. There were marked improvements in severity of itching, dryness and burning/stinging over the study course. The most common treatment-related adverse events were application site reactions of dermatitis, pruritus, pain and irritation.. Fixed-combination HP/TAZ lotion provided maintained efficacy with a favourable tolerability and safety profile, supporting its use for the long-term treatment and management of moderate-to-severe plaque psoriasis.

Topics: Administration, Cutaneous; Adult; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Humans; Nicotinic Acids; Propionates; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Psoriasis is a chronic, inflammatory disease that may differ in prevalence and clinical presentation among patients from various racial and ethnic groups. Two phase 3 studies demonstrated efficacy and safety of halobetasol propionate (HP) 0.01% lotion in the treatment of moderate-to-severe plaque psoriasis (NCT02514577, NCT02515097). These post hoc analyses evaluated HP 0.01% lotion in Hispanic participants.. Participants were randomized (2:1) to receive once-daily HP or vehicle lotion for 8 weeks, with a 4-week posttreatment follow-up. Post hoc efficacy assessments in Hispanic participants (HP, n=76; vehicle, n=43) included treatment success (≥2‑grade improvement in Investigator’s Global Assessment and score of ‘clear’ or ‘almost clear’), psoriasis signs, and affected body surface area (BSA). Treatment-emergent adverse events (TEAEs) were evaluated.. At week 8, 38.8% of participants achieved treatment success with HP versus 10.3% on vehicle (P=0.001). HP‑treated participants achieved greater improvements in psoriasis signs, compared with vehicle (P<0.01 all). HP group had a greater reduction in affected BSA versus vehicle (P=0.001). Treatment-related TEAEs with HP were application site infection and dermatitis (n=1 each).. Once-daily HP 0.01% lotion was associated with significant reductions in disease severity in Hispanic participants with moderate-to-severe psoriasis, with good tolerability and safety over 8 weeks. J Drugs Dermatol. 2021;20(3):252-258. doi:10.36849/JDD.5698.

Topics: Administration, Cutaneous; Adult; Clobetasol; Dermatitis, Contact; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Female; Hispanic or Latino; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index; Treatment Outcome; Vasoconstrictor Agents

Few studies have examined topical psoriasis therapies in patients with skin of color. Fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) was investigated in two phase 3, multicenter, double-blind, vehicle-controlled trials (NCT02462070; NCT02462122). This post hoc analysis evaluated HP/TAZ in subgroups of non-White and White participants, including Hispanic/Latino participants, from these trials.. Adult participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once daily for 8 weeks. Data were pooled and analyzed in non-mutually exclusive subgroups of self-identified non-White or White and Hispanic/Latino participants. Efficacy assessments included treatment success (≥2-grade improvement from baseline in investigator’s global assessment [IGA] and score of clear/almost clear), reduction from baseline in affected body surface area (BSA), and reduction in mean IGA × BSA. Safety was evaluated via treatment-emergent adverse events (TEAEs).. Of 418 participants, 60 and 358 self-identified as non-White and White, respectively; 115 of 418 participants self-identified as Hispanic/Latino. At week 8, a higher percentage of HP/TAZ-treated participants achieved treatment success vs vehicle (non-White, 34.4% vs 19.0%; White, 41.8% vs 8.7%; Hispanic/Latino, 39.3% vs 9.3%); rates for White and Hispanic/Latino participants were statistically significant. Compared with vehicle, HP/TAZ-treated participants in each subgroup experienced numerically greater reductions in affected BSA and IGA × BSA at week 8. The most common TEAEs were contact dermatitis, pruritus, nasopharyngitis, and application-site pain; discontinuations due to TEAEs were few.. HP/TAZ reduced disease severity in non-White, White, and Hispanic/Latino participants with psoriasis, with good tolerability and safety over 8 weeks of treatment. J Drugs Dermatol. 2021;20(7):735-744. doi:10.36849/JDD.6158.

Topics: Adult; Clobetasol; Color; Dermatologic Agents; Drug Combinations; Humans; Nicotinic Acids; Psoriasis; Skin Cream; Skin Pigmentation

Patients with psoriasis and low body surface area (BSA) involvement often experience substantially reduced quality of life and may be candidates for topical therapies. Fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) vs vehicle lotion was evaluated in participants with 3% to 5% BSA involvement.. In two phase 3, multicenter, double-blind, vehicle-controlled, 8-week studies (ClinicalTrial.gov identifiers: NCT02462070/NCT02462122), adults with moderate/severe investigator’s global assessment (IGA) score were randomized 2:1 to once-daily HP/TAZ or vehicle. Pooled post hoc analyses included participants with baseline BSA involvement of 3% to 5%. Measures included treatment success (≥2-grade IGA reduction, clear/almost clear score), reduction in affected BSA, and clinically meaningful improvement (reduction) of ≥4 points on dermatology life quality index (DLQI).. Of 418 participants, 232 had baseline BSA involvement of 3% to 5% (HP/TAZ, n=149; vehicle, n=83). At week 8, 42.7% of HP/TAZ-treated participants achieved treatment success, compared with 11.4% of vehicle-treated participants (P< .001). Participants experienced significantly greater reductions in affected BSA at week 8 with HP/TAZ (-36.0%) vs vehicle (-1.6%; P< .001). Larger proportions experienced clinically meaningful DLQI improvements at week 8 with HP/TAZ (64.2%) vs vehicle (47.4%; P< .05). More participants achieved a ≥2-grade improvement in plaque elevation and scaling with HP/TAZ vs vehicle (each comparison, P< .001). Serious adverse events and discontinuations due to treatment-emergent adverse events were rare.. In participants with plaque psoriasis and BSA involvement of 3% to 5%, HP/TAZ provided significantly improved effectiveness after 8 treatment weeks vs vehicle lotion, with clinically meaningful improvements in quality of life. J Drugs Dermatol. 2021;20(8):829-836. doi:10.36849/JDD.6217.

Topics: Body Surface Area; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Humans; Nicotinic Acids; Propionates; Psoriasis; Quality of Life; Severity of Illness Index; Skin Cream; Treatment Outcome

Background: Plaque psoriasis can occur in all body regions, with the trunk and extremities among the most commonly affected areas. A fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion demonstrated efficacy and safety in patients with moderate-to-severe localized plaque psoriasis. This analysis evaluated patients where a psoriatic target lesion was identified on the leg. Methods: In two phase 3, multicenter, double-blind studies, participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once-daily for 8 weeks. This pooled, post hoc analysis included a subset of participants who had a leg target lesion (HP/TAZ, n=148; vehicle, n=71). Efficacy assessments included treatment success (≥2-grade improvement) in psoriasis signs (erythema, plaque elevation, scaling) on the leg target lesion, and overall treatment outcomes, including overall treatment success (≥2-grade improvement in Investigator's Global Assessment [IGA] score and score of clear/almost clear), affected Body Surface Area (BSA), and IGAxBSA composite score. Results: Psoriasis signs were reduced by week 8, with more HP/TAZ treated participants achieving treatment success for erythema (41.6%), plaque elevation (58.5%), and scaling (59.5%) on the leg compared with vehicle (12.5%, 19.2%, and 21.0%, respectively; P<0.001 all). Significantly more participants achieved overall treatment success at week 8 with HP/TAZ versus vehicle (36.4% vs 10.4%; P<0.001). The HP/TAZ group also had a greater mean reduction in affected BSA and IGAxBSA score versus vehicle (P<0.001, both). The most frequently reported treatment-related adverse event (incidence, ≥3%) with HP/TAZ was contact dermatitis. Conclusions: HP 0.01%/TAZ 0.045% lotion was associated with significant reductions in disease severity and good tolerability following 8 weeks of treatment in patients where a psoriatic target lesion was identified on the leg. J Drugs Dermatol. 2020;19(4):389-396. doi:10.36849/JDD.2020.4958.

Topics: Administration, Cutaneous; Adult; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Female; Humans; Leg; Male; Middle Aged; Nicotinic Acids; Psoriasis; Severity of Illness Index; Treatment Outcome; United States

Previous results from two phase 3 studies demonstrated efficacy and safety of fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in participants with moderate-to-severe plaque psoriasis. This post hoc analysis evaluated sex-specific efficacy and safety of HP/TAZ lotion.. In two randomized, double-blind, phase 3 studies, participants were randomized (2:1) to receive HP/TAZ or vehicle lotion once daily for 8 weeks. Male and female participants were evaluated separately in this pooled analysis. Efficacy assessments included treatment success (at least 2‑grade improvement in Investigator's Global Assessment [IGA] score and score of clear/almost clear), impact on individual signs of psoriasis, and affected Body Surface Area (BSA).. The analysis included 272 males (HP/TAZ, n=175; vehicle, n=97) and 146 females (HP/TAZ, n=101; vehicle, n=45). Significantly more participants achieved overall treatment success at week 8 with HP/TAZ versus vehicle in both male (38.4% vs 9.8%) and female (44.5% vs 9.9%) subgroups (P<0.001, both). Erythema, plaque elevation, and scaling were also reduced by week 8 in both males and females, with significantly more HP/TAZ-treated participants achieving at least 2‑grade improvement in each sign of psoriasis than vehicle-treated participants (P<0.001 each, both groups). Mean reductions in affected BSA were significantly greater with HP/TAZ versus vehicle lotion in both males and females (P≤0.001, both). The most frequent treatment-related adverse events were contact dermatitis, pruritis, and application site pain (each 4.0%) in females and contact dermatitis (7.6%) in males.. HP/TAZ lotion was highly effective and safe in both males and females with moderate-to-severe psoriasis over 8 weeks of once-daily use. J Drugs Dermatol. 2020;19(5): doi:10.36849/JDD.2020.5021.

Topics: Adult; Aged; Clobetasol; Dermatitis, Contact; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Nicotinic Acids; Pain; Pruritus; Psoriasis; Severity of Illness Index; Sex Factors; Skin Cream; Treatment Outcome

Introduction: Psoriasis is a chronic, immune-mediated skin disease that is associated with sex-related differences. Two double-blind, vehicle-controlled, phase 3 studies evaluated halobetasol propionate (HP) 0.01% lotion for the treatment of moderate-to-severe localized plaque psoriasis; pooled post hoc analyses investigated efficacy and safety in male and female subgroups. Methods: Participants were randomized (2:1) to once-daily HP or vehicle lotion for 8-weeks of double-blind treatment, with a 4-week posttreatment follow-up. Post hoc efficacy assessments in male (n=253) and female (n=177) subgroups included treatment success (≥2‑grade improvement in Investigator's Global Assessment [IGA] score and score of 'clear' or 'almost clear'), treatment success in psoriasis signs (erythema, plaque elevation, and scaling) at the target lesion, and change in affected body surface area (BSA). Treatment-emergent adverse events (TEAEs) were evaluated. Results: At week 8, rates of IGA-rated treatment success were significantly greater for HP versus vehicle in males (34.0% vs 6.4%) and females (42.7% vs 14.6%; P<0.001 both). Treatment success in each psoriasis sign approached or exceeded 50% for HP-treated males and females, with all differences versus vehicle statistically significant (P<0.001). Percent reduction in affected BSA was significantly greater for HP versus vehicle in males (34.9% vs 6.7%) and females (35.6% vs 4.6%; P<0.001 both). Five HP treatment-related TEAEs (all application site-related) were reported through week 8. Conclusions: HP lotion was associated with significant reductions in disease severity in male and female participants with moderate-to-severe psoriasis, with good tolerability and safety over 8 weeks of once-daily use. In the overall pooled population, results were similar. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5250.

Topics: Adult; Aged; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index; Sex Factors; Skin Cream; Treatment Outcome

BACKGROUND: A novel foam formulation of halobetasol propionate, 0.05% (HBP-Foam) has been developed to treat plaque psoriasis in patients who prefer a thermostable topical foam with low application shear that allows for easier coverage over large and/or hirsute areas than existing formulations.\ \ OBJECTIVE: To determine the safety and effectiveness of HBP-Foam in subjects with plaque psoriasis.\ \ METHODS: Two randomized, double-blind, vehicle-controlled clinical studies were conducted in 560 adult subjects with moderate to severe plaque psoriasis. Subjects applied the assigned test article to all psoriatic plaques twice daily for 14 days. The key efficacy measures were the proportion of subjects with “treatment success,” defined as those subjects that achieved a score of 0 (clear) or 1 (almost clear) and at least a two-grade improvement compared to baseline for the Investigator’s Global Assessment (IGA) and for the clinical signs of psoriasis (plaque elevation, scaling, and erythema) as well as pruritus. Safety measurements included adverse events and local skin reactions in the treatment area.\ \ RESULTS: HBP-Foam was statistically superior to vehicle in achieving “Treatment Success” in 25.3% and 30.7% vs 3.9% and 7.4% (P<0.001) in Studies 1 and 2, respectively. Pruritus scores statistically improved by over 30% in HBP-Foam treated subjects. In addition, these subjects experienced a significant reduction in the clinical signs of psoriasis (plaque elevation, scaling, and erythema). In contrast, in the vehicle groups the decrease in psoriasis-related signs was generally not observed. Safety outcomes were unremarkable and similar in both the HBP-Foam and vehicle treatment groups.\ \ CONCLUSIONS: These results demonstrate the safety and effectiveness of HBP-Foam in the treatment of plaque psoriasis. Furthermore, this novel foam formulation has demonstrable for its ease of application over large and/or hairy treatment areas.\ \ ClinicalTrials.gov Registration: NCT02742441 NCT02368210

Topics: Adult; Aged; Clobetasol; Dermatologic Agents; Double-Blind Method; Female; Humans; Male; Middle Aged; Pharmaceutical Vehicles; Pruritus; Psoriasis; Severity of Illness Index; Skin; Treatment Outcome; Vasoconstrictor Agents

BACKGROUND: Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Topical corticosteroids (TCS) are the mainstay of treatment. Long-term safety remains a concern, limiting use and recurrence is common. Tazarotene has also been shown to be effective in psoriasis, with efficacy maintained several weeks posttreatment. Fixed combination therapy with TCS and tazarotene may improve psoriasis signs and maintain efficacy between treatment sessions.\ \ OBJECTIVE: To investigate the maintenance of effect posttreatment with a once-daily application of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in comparison with vehicle in patients with moderate or severe plaque psoriasis.\ \ METHODS: Two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies in moderate or severe psoriasis (N=418). Patients randomized (2:1) to receive HP/TAZ lotion or vehicle, once-daily for 8 weeks with a 4 week posttreatment follow-up. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score, and ‘clear’ or ‘almost clear’), impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion, and maintenance of improvements in Body Surface Area (BSA), IGAxBSA and clinically meaningful benefit (IGAxBSA-75).\ \ RESULTS: At week 8, 40.7% of patients achieved treatment success with HP/TAZ lotion, compared with 9.9% treated with vehicle (P<0.001). Four weeks posttreatment, 33.3% of patients achieved treatment success. Two thirds of patients (63%) who were treatment successes at week 8 remained treatment successes posttreatment. In addition, up to 20% of patients who were not treatment successes at week 8 became treatment successes by the end of the study. Three-quarters of patients maintained BSA improvements or reported further reductions in BSA that seemed to be unrelated to baseline BSA severity. At the end of the 4 week posttreatment period, patients who had been treated with HP/TAZ lotion achieved a 46.6% reduction in IGAxBSA, compared with 7.9% on vehicle. 41.7% of patients achieved a clinically meaningful effect at week 8 and this was maintained posttreatment.\ \ LIMITATIONS: The studies only had a 4 week follow-up period.\ \ CONCLUSIONS: In conclusion, HP 0.01%/TAZ 0.045% lotion provides effective maintenance of efficacy over a 4 week posttreatment period.

Topics: Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Follow-Up Studies; Humans; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Background: The use of topical therapy is a key component in the management of almost all psoriasis patients. Topicals are considered first-line therapy for mild disease and are having an increasing role in moderate or severe psoriasis as an integral part of combination therapy. Halobetasol has been shown be effective in moderate or severe localized plaque psoriasis, and tazarotene affords important effects on epidermal hyperproliferation that may be important in more severe disease.\ \ Objective: To investigate the efficacy, safety and tolerability of a once-daily application of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion in comparison with its vehicle in patients with severe localized plaque psoriasis (as defined by an Investigator Global Assessment (IGA) of 4 and Body Surface Area (BSA) of 3%-12%.\ \ Methods: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies. Sixty-two patients with severe localized psoriasis (mean BSA 7.4) randomized (2:1) to receive HP/TAZ lotion or vehicle, once-daily for 8 weeks, with a 4-week posttreatment follow-up. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score and a score of ‘clear’ or ‘almost clear’), impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion, BSA, reduction in mean baseline IGAxBSA and achievement of a clinically meaningful response (number of patients who achieved at least a 75% improvement in IGAxBSA). Safety and treatment emergent adverse events (TEAEs) were evaluated throughout.\ \ Results: By week 8, 34.8% of patients were treatment successes compared with 0.0% on vehicle (P=0.004). HP/TAZ lotion was also significantly superior in reducing psoriasis signs and symptoms and improving BSA. At week 8, 47.4% (erythema), 66.4% (plaque elevation), and 65.4% (scaling) subjects achieved at least a 2-grade improvement, compared with 14.0% (P=0.016), 14.8% (P<0.001) and 14.7% (P<0.001) respectively with vehicle. Patients treated with HP/TAZ lotion achieved a 32.8% reduction in baseline mean BSA, compared with a 39.6% increase with vehicle (P=0.013). HP/TAZ lotion achieved a statistically significant superior reduction in mean IGAxBSA compared to vehicle from week 2 (P<0.001 versus vehicle). By week 8, almost half of the patients treated with HP/TAZ lotion achieved a clinically meaningful response (IGAxBSA-75) and

Topics: Adult; Clobetasol; Dermatitis, Contact; Dermatologic Agents; Double-Blind Method; Drug Combinations; Female; Humans; Male; Middle Aged; Nicotinic Acids; Pain; Pruritus; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Background: Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Topical corticosteroids (TCS) are the mainstay of treatment. Long-term safety remains a concern, limiting use, and posttreatment flare is common. Recently data were reported on the use of halobetasol propionate (HP) 0.01% lotion in moderate or severe localized plaque psoriasis, once-daily for 8 weeks. In addition, a 2-week label-restricted study reported comparable efficacy to HP 0.05% cream. Data evaluating efficacy in specific locations has not been reported and while psoriasis commonly affects lower extremities treatment can be more problematic and burden of disease heightened.\ \ Objective: To investigate the efficacy of a once-daily application of HP 0.01% lotion in comparison with its vehicle in patients with moderate-to-severe plaque psoriasis of the lower extremities.\ \ Methods: A post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies in moderate or severe psoriasis. Subjects (N=234) where the leg was identified as the target lesion were randomized (2:1 ratio) to receive HP 0.01% lotion or vehicle, once-daily for 8 weeks. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline) in each individual sign of psoriasis (erythema, plaque elevation, and scaling) at the target lesion (leg) and overall treatment outcomes including at least a 2-grade improvement from baseline in the Investigator Global Assessment (IGA) score, and ‘clear’ or ‘almost clear’, improvement in Body Surface Area (BSA) and reduction in IGAxBSA. Quality of Life (QoL) was assessed using the Dermatology Life Quality Index (DLQI) at baseline, week 4, 8, and 12.\ \ Results: At the end of the 8-week treatment period, more than half of subjects had achieved treatment success, with 52.1%, 55.5%, and 58.2% of subjects achieving at least a 2-grade reduction in erythema, plaque elevation and scaling severity on the leg, compared with 15.7% and 22.9%, and 22.2% of those treated with vehicle (P<0.001). In addition, overall treatment success (IGA) was achieved in 37.1% of these subjects who had been treated with HP 0.01% lotion compared with 8.4% treated with vehicle (P<0.001); with a corresponding 34.2% reduction in baseline BSA and 50.5% change in mean baseline IGAxBSA (both P<0.001 versus vehicle). Overall, a clinically relevant improvement in QoL was achieved by week 4; by week 8 37.7% of subjects wh

Topics: Adult; Aged; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Female; Humans; Lower Extremity; Male; Middle Aged; Psoriasis; Quality of Life; Severity of Illness Index; Skin Cream; Treatment Outcome

Topics: Administration, Cutaneous; Adult; Aged; Clobetasol; Dermatologic Agents; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Middle Aged; Psoriasis; Skin Cream; Treatment Outcome

Topics: Adult; Aged; Aged, 80 and over; Clobetasol; Dermatologic Agents; Drug Therapy, Combination; Humans; Middle Aged; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Time Factors; Young Adult

Potent topical corticosteroids (TCSs) are the mainstay of psoriasis treatment. Safety concerns have limited use to 2 to 4 weeks. The objective of our study was to investigate the safety and efficacy of once-daily halobetasol propionate (HP) lotion 0.01% in moderate to severe plaque psoriasis through 2 multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Participants were randomized (2:1) to HP lotion 0.01% or vehicle once daily for 8 weeks, followed by 4 weeks of follow-up. The primary efficacy assessment was treatment success (at least a 2-grade improvement in baseline investigator global assessment [IGA] score and a score of 0 [clear] or 1 [almost clear]). Additional assessments included improvement in psoriasis signs and symptoms, body surface area (BSA), and a composite score of IGA×BSA. Safety and treatment-emergent adverse events (AEs) were evaluated throughout. We found that HP lotion 0.01% demonstrated statistically significant superiority over vehicle as early as week 2 and also was superior in reducing psoriasis signs and symptoms and BSA involvement.

Topics: Administration, Cutaneous; Adult; Aged; Clobetasol; Dermatologic Agents; Double-Blind Method; Female; Follow-Up Studies; Glucocorticoids; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index; Treatment Outcome

Background: Fixed combinations are commonplace in dermatology, providing significant efficacy and tolerability benefits. In some cases, two active ingredients complement each other providing a cumulative or additive effect. In rarer cases, a synergistic effect may be seen where the sum of the two active ingredients combined action is greater than the sum of the efficacy of the constituent parts.\ \ Objective: To determine whether a novel halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) fixed combination lotion provides a synergistic effect in the treatment of moderate-to-severe plaque psoriasis.\ \ Methods: Post hoc analysis of 212 patients with moderate-to-severe plaque psoriasis randomized (2:2:2:1) to HP/TAZ lotion, HP, TAZ or vehicle once-daily for 8 weeks, with a 4-week posttreatment follow-up. Treatment success was evaluated based on two outcomes: percent of patients achieving at least a 2-grade improvement in Investigator Global Assessment (IGA) and IGA score equating to ‘clear’ or ‘almost clear’; and percent change from baseline in the IGAxbody surface area (BSA) score, an alternative to assessing response to therapy that is more sensitive to area change than the Psoriasis Area Severity Index (PASI). In addition, a clinically meaningful outcome was reported in patients who achieved a 75% reduction in IGAxBSA. Synergy was established when the benefit of combination HP/TAZ lotion was greater than benefit of HP plus TAZ, with a ratio (HP/TAZ divided by HP+TAZ) >1.0.\ \ Results: HP/TAZ lotion was synergistic at week 8, and four weeks posttreatment. At week 8, treatment success with HP/TAZ lotion relative to vehicle was 42.8% compared with 32.5% for HP plus TAZ (ratio 1.3); and percent change from baseline in IGAxBSA score relative to vehicle was 51.6% compared with 40.6% for HP plus TAZ (ratio 1.3). At week 12, treatment success with HP/TAZ lotion relative to vehicle was 31.3% compared with 20.0% for HP plus TAZ (ratio 1.6). Percent change from baseline in IGAxBSA score relative to vehicle was 47.3% compared with 34.2% for HP plus TAZ (ratio 1.4). HP/TAZ lotion also provided synergistic benefits in terms of achieving a clinically meaningful outcome, with a ratio of 1.3 and 2.0 at weeks 8 and 12.\ \ Conclusions: Halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) fixed combination lotion provides a synergistic benefit in the treatment of moderate-to-severe plaque psoriasis. In addition, by combining two agents into one once-daily formulation

Topics: Administration, Cutaneous; Clobetasol; Dermatologic Agents; Drug Combinations; Drug Synergism; Follow-Up Studies; Humans; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Topical corticosteroids are the mainstay of psoriasis treatment, with long-term safety considerations limiting their use. Combining them with tazarotene may optimize their efficacy and minimize safety and tolerability concerns.. To investigate the safety and efficacy of halobetasol propionate 0.01% plus tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis.. Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N = 418) were conducted. Subjects were randomized (2:1) to HP/TAZ lotion or vehicle once daily for 8 weeks with a 4-week follow-up. The primary efficacy assessment end point was treatment success (at least a 2-grade improvement from baseline in Investigator's Global Assessment score and a score of clear or almost clear). Safety and treatment-emergent adverse events were evaluated throughout.. HP/TAZ lotion demonstrated statistically significant superiority over vehicle within as few as 2 weeks. By week 8, 35.8% (study 1) and 45.3% (study 2) of subjects were treatment successes compared with 7.0% and 12.5% of those treated with vehicle (P < .001). HP/TAZ lotion was also superior in reducing signs and symptoms of psoriasis and body surface area affected by psoriasis. The most frequently reported treatment-related adverse events were contact dermatitis (6.3%), application site pain (2.6%), and pruritus (2.2%).. Studies did not include subjects with more than 12% of their body surface area affected by psoriasis.. HP/TAZ lotion was associated with significant reductions in the severity of the clinical signs of psoriasis, with no safety concerns.

Topics: Administration, Cutaneous; Chronic Disease; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Drug Synergism; Female; Humans; Male; Middle Aged; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Topical corticosteroids (TCS) are the mainstay of treatment. Long-term safety remains a concern, limiting use, and posttreatment flare is common. Tazarotene has also been shown to be effective in psoriasis, with efficacy maintained several weeks posttreatment. Fixed combination therapy with TCS and tazarotene may improve psoriasis signs and minimize posttreatment flare or rebound.. To investigate the maintenance of effect posttreatment with a once-daily application of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in comparison with its active ingredients and vehicle in patients with moderate-to-severe plaque psoriasis.. Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study in moderate or severe psoriasis (N=212). Patients randomized (2:2:2:1 ratio) to receive HP/TAZ, individual active ingredients, or vehicle, once-daily for 8 weeks with a 4-week posttreatment follow-up. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score, and 'clear' or 'almost clear'), and impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion.. At the end of the 4-week posttreatment period, 38.2% of patients who had been treated with HP/TAZ were treatment successes; compared with 21.0%, 12.8% and 6.9% of patients who had been treated with HP (P=0.042), TAZ (P=0.004), or vehicle (P=0.002). HP/TAZ lotion was also superior in maintaining reductions in psoriasis signs of erythema, plaque elevation, and scaling at the target lesion. At the end of the 4-week posttreatment period, 49.1%, 54.5%, and 54.5% of patients, respectively, were treatment successes: compared with 38.7% (P=0.26), 48.4% (P=0.51), and 48.4% (P=0.51) of patients who had been treated with HP; 29.8% (P=0.049), 31.9% (P=0.022), and 23.4% (P=0.001) who had been treated with TAZ; and 13.8% (P=0.002), 20.7% (P=0.003), and 20.7% (P=0.003) who had been treated with vehicle. Side effects were minimal and tended to resolve during the posttreatment period.. In conclusion, HP 0.01%/TAZ 0.045% lotion provides synergistic efficacy following 8 weeks' therapy that is sustained after a 4-week posttreatment period. J Drugs Dermatol. 2018;17(7):723-726.

Topics: Administration, Cutaneous; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Drug Synergism; Humans; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Psoriasis is a chronic condition often managed with topical therapy. Patients have high expectations about the speed at which improvement is achieved, which then can have a marked impact on the patient's adherence to treatment. Recently, clinical data on a new fixed combination of halobetasol and tazarotene (HP/TAZ) have been presented. HP/TAZ lotion was statistically more effective than individual active ingredients or its vehicle, with a predictable safety profile.. Here we review the efficacy and tolerability data with a specific focus on the first two weeks of therapy.. Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study in moderate or severe psoriasis (N=212). Subjects randomized (2:2:2:1 ratio) to receive halobetasol 0.01%/tazarotene 0.045% (HP/TAZ), individual active ingredients (HP or TAZ), or vehicle, once-daily for 8 weeks. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score and a score of 'clear' or 'almost clear'), and impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion.. As early as 2 weeks, HP/TAZ lotion demonstrated statistically significant superiority for treatment success over vehicle (P equals 0.047) and TAZ (P equals 0.029). By week 2, 47.5% of patients were 'mild', 'almost clear' or 'clear' compared with 33.3%, 16.9%, and 12.9% of patients treated with HP, TAZ, or vehicle, respectively; plaque elevation and scaling were significantly improved compared with HP, TAZ, or vehicle, and erythema was significantly improved compared with TAZ. Improvements in baseline itching (45.6%), dryness (42.2%), burning/stinging (55.9%) with HP/TAZ lotion at 2 weeks were similar to those seen with HP, and greater than that achieved with TAZ (30.8% [P equals 0.099], 35.4%, and 13.3%, respectively).. The HP/TAZ fixed combination lotion provides rapid relief of psoriasis symptoms, with apparent benefits over both HP and TAZ by week 2. J Drugs Dermatol. 2018;17(8):863-868.

Topics: Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Drug Compounding; Humans; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Time Factors; Treatment Outcome; Vasoconstrictor Agents

Topical corticosteroids (TCS) are the mainstay of psoriasis treatment; long-term safety concerns limiting consecutive use of potent TCS to 2-4 weeks.. Investigate safety and efficacy of halobetasol propionate 0.01% lotion in moderate-to-severe plaque psoriasis.. Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Subjects randomized (2:1) to halobetasol propionate 0.01% lotion or vehicle once-daily for 8 weeks, 4-week posttreatment follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in Investigator Global Assessment [IGA] score and 'clear' or 'almost clear') at week 8. Safety and treatment emergent adverse events (AEs) evaluated throughout.. Halobetasol propionate 0.01% lotion demonstrated statistically significant superiority over vehicle as early as week 2. By week 8, 36.5% (Study 1) and 38.4% (Study 2) of subjects were treatment successes compared with 8.1% and 12.0% on vehicle (P less than 0.001). Halobetasol propionate 0.01% lotion was also superior in reducing psoriasis signs and symptoms, body surface area (BSA), and improving quality of life. Halobetasol propionate 0.01% lotion was well-tolerated with no treatment-related AEs greater than 1%.. Study did not include subjects with BSA greater than 12.. Halobetasol propionate 0.01% lotion was associated with significant reductions in the severity of the clinical signs of psoriasis, without the safety concerns of a longer treatment course. J Drugs Dermatol. 2018;17(10):1062-1069.

Topics: Administration, Cutaneous; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Psoriasis; Randomized Controlled Trials as Topic; Severity of Illness Index; Skin Cream; Treatment Outcome; United States

Background: A unique fixed combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion has been shown to be effective in psoriasis using Investigator Global Assessment (IGA) tools to assess erythema, plaque elevation, and scaling. However, these do not consider changes in Body Surface Area (BSA). The IGAxBSA composite tool is a simple, effective, validated alternative for measuring improvement in psoriasis severity. It correlates well with the Psoriasis Area and Severity Index (PASI) and demonstrates sensitivity to changes from baseline in patients with both mild and moderately severe disease.\ Objective: To further define the role of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis using the IGAxBSA composite tool.\ Methods: Post hoc analysis of 212 patients with moderate-to-severe plaque psoriasis randomized (2:2:2:1) to HP/TAZ lotion, HP, TAZ, or vehicle once-daily for 8 weeks, with a 4-week posttreatment follow-up. Efficacy assessments using the validated IGAxBSA composite tool.\ Results: HP/TAZ lotion demonstrated statistically significant superiority at week 8 (versus TAZ and vehicle) and week 12 (versus HP, TAZ, and vehicle). By week 8, HP/TAZ lotion achieved a 63.5% reduction in mean IGAxBSA composite score (P<0.001 versus TAZ and vehicle), that was sustained four weeks posttreatment (P<0.001 versus TAZ and vehicle and P=0.003 versus HP). A 25% and 50% improvement in IGAxBSA was achieved within 1.9 and 4.6 weeks, respectively, and 47.5% of patients achieved IGAxBSA-75 by week 8.\ Limitations: This post hoc analysis was limited to patients with moderate-to-severe plaque psoriasis with IGA ≥3 and BSA involvement (3%-12%).\ Conclusions: HP/TAZ lotion was associated with significant and rapid reductions in disease severity as assessed by the IGAxBSA composite tool. The addition of tazarotene affords sustained benefits posttreatment.\ J Drugs Dermatol. 2018;17(12):1290-1296.

Topics: Administration, Cutaneous; Clobetasol; Dermatologic Agents; Drug Combinations; Emulsions; Humans; Nicotinic Acids; Psoriasis; Severity of Illness Index; Treatment Outcome

This study measured skin hydration and occlusivity of two test products [halobetasol propionate lotion, 0.05% (HBP Lotion) and Ultravate® (halobetasol propionate) cream, 0.05% (HBP Cream)] at 2, 4, and 6 hours after application to skin test sites previously challenged by dry shaving, which was performed to compromise the integrity of the stratum corneum barrier.. Trans-epidermal water loss (TEWL), an indicator of skin barrier function, was measured using cyberDERM, inc. RG-1 evaporimeter. Skin hydration was evaluated using IBS SkiCon-200 conductance meter. Test products were applied bilaterally on dry-shaved sites on the volar forearm sites, according to a randomization scheme, with two test sites untreated to serve as "dry-shaved" controls. TEWL and conductance were measured at 2, 4, and 6 hours post-treatment.. HBP Lotion displayed a significant increase in skin hydration at 2, 4, and 6 hours post-treatment compared to the baseline values and dry-shaved controls (each, P less than 0.001). However, HBP Cream produced statistically significant increased skin hydration only after 6 hours (P less than 0.05). HBP Lotion was significantly more effective than HBP Cream in increasing skin hydration at 2 and 4 hours post-treatment (each, P less than 0.001), and had a directional advantage (not statistically significant) at 6 hours. Neither test product had a significant occlusive effect as measured by TEWL at 2, 4, and 6 hours post-application.. Both formulations of HBP (Lotion and Cream) contributed to skin moisturization, as measured by skin conductance. HBP Lotion produced a significantly more rapid onset and higher level of moisturization at 2 and 4 hours post-application compared to HBP Cream. The TEWL results indicate that neither HBP Lotion nor HBP Cream provided any significant occlusivity to the skin.

J Drugs Dermatol. 2017;16(2):140-144.

Topics: Administration, Cutaneous; Adult; Clobetasol; Dermatitis, Atopic; Dermatologic Agents; Double-Blind Method; Drug Compounding; Emollients; Female; Forearm; Humans; Male; Middle Aged; Skin Cream; Vasoconstrictor Agents; Water Loss, Insensible; Young Adult

BACKGROUND: Psoriasis is a chronic, immune-mediated disease that varies widely in its clinical expression. Treatment options focus on relieving symptoms, reducing inflammation, induration, and scaling, and controlling the extent of the disease. Topical corticosteroids are the mainstay of treatment, however long-term safety remains a concern, particularly with the more potent formulations. Combination therapy with a corticosteroid and tazarotene may improve psoriasis signs at a lower corticosteroid concentration providing a superior safety profile.. To investigate the efficacy and safety of a once-daily application of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% (HP/TAZ) lotion in comparison with its monads and vehicle in subjects with moderate-to-severe plaque psoriasis.. Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study in moderate or severe psoriasis (N=212). Subjects randomized (2:2:2:1 ratio) to receive HP/TAZ, individual monads, or vehicle, once-daily for 8 weeks. Efficacy assessments included treatment success (defined as at least a 2-grade improvement from baseline in the IGA score and a score of 'Clear' or 'Almost Clear'), and impact on individual signs of psoriasis (erythema, plaque elevation, and scaling) at the target lesion. Safety and treatment emergent adverse events (TEAEs) were evaluated throughout.. HP/TAZ lotion demonstrated statistically significant superiority over vehicle as early as 2 weeks. At week 8, 52.5% of subjects had treatment success compared with 33.3%, 18.6%, and 9.7% in the HP (P=0.033), TAZ (P less than 0.001), and vehicle (P less than 0.001) groups, respectively. HP/TAZ lotion was superior to its monads and vehicle in reducing the psoriasis signs of erythema, plaque elevation, and scaling at the target lesion. At week 8, a 2-grade improvement in IGA was achieved by 54.2% of subjects for erythema, 67.8% for plaque elevation, and 64.4% for scaling. Most frequently reported TEAEs were application site reactions, and were more likely associated with the tazarotene component. Side effects such as skin atrophy were rare.. HP/TAZ lotion was consistently more effective than its monads or vehicle in achieving treatment success and reducing psoriasis signs of erythema, plaque elevation, and scaling at the target lesion. Safety data were consistent with the known safety profile of halobetasol propionate and tazarotene, and did not reveal any new safety concerns with the combination product.

J Drugs Dermatol. 2017;16(3):197-204.

Topics: Administration, Cutaneous; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Female; Glucocorticoids; Humans; Male; Nicotinic Acids; Pharmaceutical Vehicles; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

BACKGROUND: A novel lotion formulation of halobetasol propionate, 0.05% (HBP Lotion) with enhanced vehicle characteristics of a cream while preserving the ease of use and cosmetic elegance of a lotion has been developed to treat plaque psoriasis.. Determine the safety and effectiveness of HBP Lotion in patients with plaque psoriasis.. Two prospective, randomized, vehicle-controlled clinical studies were conducted in 443 adult subjects with moderate-severe plaque psoriasis. Subjects applied the test article to psoriatic plaques within the treatment area twice daily for 14 days. Efficacy data are based upon treatment "success" defined as those subjects that achieved scores of 0=clear or 1=almost clear with at least a two-grade improvement relative to baseline for an Investigator's Global Assessment (IGA) and clinical signs (plaque elevation, erythema, scaling). Safety data are presented as adverse events and local skin reactions.. After two weeks of treatment with HBP Lotion, 44.5% of the HBP Lotion treated subjects in each study achieved (a) treatment "success" (ie, an IGA score of 0=clear or 1=almost clear and >2 grade improvement compared to baseline) and (b) a notable reduction in plaque elevation, erythema, scaling, and pruritus. In contrast, only 6.3% and 7.1% of VEH subjects in Studies 1 and 2, respectively, achieved treatment success and the reduction of disease related signs was materially lower. Statistically, at day 15 in both Phase 3 studies, treatment success with HBP Lotion was superior to VEH (P less than 0.001). From a safety perspective the outcomes were in general unremarkable with similar findings in the HBP Lotion and VEH treatment groups.. The results demonstrate the safety and effectiveness of HBP Lotion in the treatment of plaque psoriasis. Furthermore, this novel HBP lotion formulation is also distinguished by its moisturization qualities and ease of use.

J Drugs Dermatol. 2017;16(3):234-240.

Topics: Administration, Cutaneous; Adult; Clobetasol; Double-Blind Method; Female; Glucocorticoids; Humans; Male; Pharmaceutical Vehicles; Prospective Studies; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Topical corticosteroids are the most common first-line treatment for psoriasis. Tachyphylaxis, a decreased response to treatment with repetitive application of the drug, is a controversial phenomenon associated with topical corticosteroid treatment.. We sought to prove or disprove tachyphylaxis to occluded halobetasol 0.05% versus vehicle.. Patients with plaque psoriasis were recruited to this study. The study involved 3 phases (1, 2A, and 2B) with each phase being separated by a treatment vacation period. In phases 1 and 2A, 2 plaques were randomized to either halobetasol 0.05% or vehicle ointment application. In phase 2B, halobetasol 0.05% was applied to both. Target Lesion Severity Scale was used for clinical assessment.. Twenty patients were enrolled. No difference in time to clearance (P=.88) or time to recurrence (P=.92) of the treated plaques was found between phases 1 and 2A. Percentage of improvement was higher in phase 2A compared with phase 1 (89.4%, P<.05 vs 71%, P<.05), as a result of reduction of vehicle effect. In phase 2B, a greater improvement was found for previously corticosteroid-treated plaques.. Limitations are small sample size and 1 corticosteroid tested.. No evidence of tachyphylaxis to the topical corticosteroid halobetasol 0.05% ointment treatment in patients with plaque psoriasis was found.

Topics: Administration, Cutaneous; Adult; Clobetasol; Dermatologic Agents; Double-Blind Method; Female; Humans; Male; Middle Aged; Ointments; Pilot Projects; Psoriasis; Severity of Illness Index; Tachyphylaxis; Young Adult

This study compared the efficacy of a novel, topical class I synthetic, 0.10% fluocinonide corticosteroid with two other class I corticosteroids and placebo for the treatment of plaque psoriasis.. A 0.5 gram dose of fluocinonide 0.1% cream, clobetasol propionate 0.05% cream, halobetasol propionate 0.05% cream, and placebo ointment were applied to test sites on one psoriatic plaque per patient (n=5). Test sites were outlined according to the Scholtz-Dumas bioassay. Test sites were assessed by a blinded evaluator (1 = psoriasis worsened to 5 = psoriasis clear or almost clear), cleaned and medications were reapplied on days 3, 5, 7, 10 and 12.. The three class I corticosteroid products were comparably effective, numerically and statistically, in clearing the psoriatic plaques. Upon completion of treatment, 60-80% of active-treated sites were clear or almost clear of psoriasis compared to zero with the placebo.

Topics: Administration, Cutaneous; Aged, 80 and over; Biological Assay; Clobetasol; Dermatologic Agents; Female; Fluocinonide; Glucocorticoids; Humans; Male; Middle Aged; Psoriasis; Severity of Illness Index; Single-Blind Method; Treatment Outcome

Weekend therapy with superpotent topical corticosteroids has been used for the long-term treatment of psoriasis. Recently, calcipotriene ointment has been added to this regimen for use on weekdays, but there are no long-term studies of that combination.. The purpose of this study was to determine whether the addition of weekday calcipotriene to a pulse therapy regimen of weekend superpotent corticosteroids results in a longer duration of remission of plaque psoriasis.. This was a double-blind, placebo-controlled, parallel-group study. Forty-four patients with mild to moderate psoriasis were treated with calcipotriene ointment in the morning and halobetasol ointment in the evening for 2 weeks. Thereafter, 40 patients who were at least moderately (50% or greater) improved were randomized to 2 treatment groups. After 2 weeks of treatment with calcipotriene ointment in the morning and halobetasol ointment in the evening, 20 patients were randomized to receive halobetasol ointment twice daily on weekends and calcipotriene ointment twice daily on weekdays, and 20 patients were randomized to receive halobetasol ointment twice daily on weekends and placebo ointment twice daily on weekdays.. Seventy-six percent of patients applying halobetasol ointments on weekends and calcipotriene ointment on weekdays were able to maintain remission for 6 months compared with 40% of patients applying halobetasol ointment on weekends only with the vehicle on weekdays.. The addition of calcipotriene ointment applied on weekdays to a weekend pulse therapy regimen of superpotent corticosteroids can increase the duration of remission of psoriasis.

Topics: Administration, Topical; Adult; Calcitriol; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Administration Schedule; Humans; Ointments; Psoriasis; Time Factors

Topics: Administration, Cutaneous; Adult; Calcitriol; Clobetasol; Dermatologic Agents; Drug Combinations; Female; Humans; Male; Ointments; Psoriasis; Remission Induction; Vasoconstrictor Agents

Topics: Betamethasone; Clobetasol; Double-Blind Method; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Pituitary-Adrenal System; Psoriasis

Both halobetasol propionate and clobetasol 17-propionate exerted very marked antiinflammatory, antiproliferative, and vasoconstrictive effects during evaluation in a range of dermatopharmacologic models. Halobetasol propionate was distinctly more potent than clobetasol 17-propionate in the ultraviolet-induced dermatitis inhibition assay in guinea pigs and in the rat model of oxazolone-induced late inflammatory reaction. Halobetasol propionate was slightly more potent than clobetasol 17-propionate in inhibiting croton oil-induced ear edema in rats and mice and in the mouse model of oxazolone-induced early inflammatory reaction. In the cotton-pellet granuloma assay in rats and the epidermal hyperplasia inhibition assay in guinea pigs, halobetasol propionate was distinctly superior to clobetasol 17-propionate. There was a trend in favor of halobetasol propionate in the cutaneous vasoconstriction assay performed in volunteers with ethanol solutions of halobetasol propionate and clobetasol 17-propionate. In a further vasoconstriction assay, performed with a 0.05% concentration of both halobetasol propionate and clobetasol 17-propionate in cream and ointment formulations, halobetasol propionate ointment yielded the highest blanching score. In a hypothalamic-pituitary-adrenal axis study in volunteers, effects of 0.05% halobetasol propionate ointment and 0.05% clobetasol 17-propionate ointment on serum cortisol levels were similar. The overall efficacy trends demonstrated in these dermatopharmacologic studies are in agreement with predictions made from corticosteroid structure and activity relationships and the results of two clinical trials comparing halobetasol propionate and clobetasol 17-propionate ointments in the treatment of plaque psoriasis.

Topics: Animals; Clobetasol; Female; Guinea Pigs; Humans; Male; Mice; Rats; Skin Diseases; Vasoconstrictor Agents

In a double-blind, parallel-group, multicenter trial in 134 patients with severe, localized, plaque psoriasis, the success rate (described as "healed" or "marked improvement") at the end of the study was 96% in the halobetasol propionate group and 91% in the clobetasol propionate group. A significantly larger proportion of patients treated with halobetasol had no disease or mild disease after 14 days compared with those treated with clobetasol (86% versus 70%, p = 0.023). Healing within 24 days of starting treatment was noted in 69% and 56% of patients treated with halobetasol and clobetasol, respectively. Adverse effects were reported in a smaller percentage of patients treated with halobetasol propionate ointment than in those treated with clobetasol propionate ointment (7% versus 12%). Cosmetic acceptability and ease of application were recorded as "very good" in a larger percentage of patients treated with halobetasol propionate ointment than in the group treated with clobetasol propionate (90% versus 80%).

Topics: Adult; Aged; Chronic Disease; Clobetasol; Double-Blind Method; Female; Humans; Male; Middle Aged; Ointments; Patient Satisfaction; Psoriasis; Remission Induction; South Africa; Vasoconstrictor Agents; Wound Healing

In a double-blind, parallel-group, multicenter comparative trial on 104 evaluable patients with severe, localized plaque psoriasis, 0.05% halobetasol propionate ointment demonstrated an 88.7% success rate assessed as "healed" or "marked improvement" compared with 78.5% for 0.05% betamethasone dipropionate ointment. Healing was observed within 24 days of the start of treatment in 40% and 25% of the patients who received halobetasol propionate and betamethasone dipropionate ointments, respectively. After 4 weeks' treatment, tolerability of both ointments was good. Neither skin atrophy nor systemic adverse effects were observed. Patient acceptance of halobetasol propionate ointment, based on cosmetic acceptability and ease of application, was significantly better (p = 0.02) than that of betamethasone dipropionate ointment.

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Betamethasone; Chronic Disease; Clobetasol; Double-Blind Method; Female; Germany; Glucocorticoids; Humans; Male; Middle Aged; Ointments; Patient Satisfaction; Psoriasis; Remission Induction; Vasoconstrictor Agents; Wound Healing

In a double-blind, parallel-group, multicenter comparative trial in 84 evaluable patients with severe, localized plaque psoriasis, 0.05% halobetasol propionate ointment proved significantly superior (p = 0.02) to 0.1% betamethasone valerate ointment with respect to the success rate, as indicated by ratings of "healed" or "marked improvement" (88.1% versus 64.3%). The therapeutic effect was observed within 5 days of the start of treatment in 76% and 67% of the patients treated with halobetasol propionate and betamethasone valerate ointments, respectively. Both preparations were well tolerated. Minor adverse effects at the site of application were reported in only 2% of the patients in each treatment group. Neither skin atrophy nor systemic adverse effects were observed.

Topics: Adult; Aged; Betamethasone Valerate; Chronic Disease; Clobetasol; Double-Blind Method; Female; Humans; Male; Middle Aged; Ointments; Patient Satisfaction; Psoriasis; Remission Induction; Switzerland; Vasoconstrictor Agents; Wound Healing

In a double-blind, parallel-group, multicenter comparative trial in 127 evaluable patients with chronic, localized atopic dermatitis or lichen simplex chronicus, healing was reported in a higher percentage of patients treated with halobetasol propionate ointment than in those in the clobetasol propionate treatment group (65.1% versus 54.7%). The success rates (described as "healed" and "marked improvement") were practically identical in the two treatment groups (93.7% versus 92.2%). Early onset of therapeutic effect, that is, within 3 days of the start of treatment, was similar in the two treatment groups (24% versus 28%). Both preparations were well tolerated. Adverse effects were reported in 5% and 2% of the patients treated with halobetasol propionate and clobetasol propionate ointments, respectively.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Chronic Disease; Clobetasol; Dermatitis, Atopic; Double-Blind Method; Female; Germany; Humans; Male; Middle Aged; Neurodermatitis; Ointments; Patient Satisfaction; Remission Induction; Vasoconstrictor Agents; Wound Healing

In a double-blind, parallel-group, multicenter, comparative trial in 120 evaluable patients with chronic, localized atopic dermatitis or lichen simplex chronicus, the success rate (described as "healed" and "marked improvement") was 91.5% in patients treated with halobetasol propionate ointment and 83.6% in those in the diflucortolone valerate treatment group. Of patients treated with halobetasol propionate ointment, 40.7% reported healing within 17 days, whereas of those in the diflucortolone valerate treatment group, 32.8% reported healing within that time. Early onset of therapeutic effect, that is, within 3 days of the start of treatment, was reported in a higher percentage of patients treated with halobetasol propionate ointment than in those treated with diflucortolone valerate ointment (70% versus 59%). Adverse effects at the site of application were less frequently reported in patients belonging to the halobetasol propionate treatment group than in those treated with diflucortolone valerate ointment (3% versus 8%).

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Austria; Chronic Disease; Clobetasol; Dermatitis, Atopic; Diflucortolone; Double-Blind Method; Female; Humans; Male; Middle Aged; Neurodermatitis; Ointments; Patient Satisfaction; Remission Induction; Vasoconstrictor Agents; Wound Healing

In two double-blind, parallel-group, multicenter trials, 0.05% halobetasol propionate cream was compared with 0.05% clobetasol 17-propionate cream and 0.05% betamethasone dipropionate cream in 264 patients with acute, severe exacerbations of atopic dermatitis. The efficacy of halobetasol propionate cream and betamethasone dipropionate cream was similar with regard to the success rate, as indicated by ratings of "healed" and "marked improvement" (88% versus 90%) and by an onset of therapeutic effect within 3 days of the start of treatment (40% versus 39%). The efficacy of halobetasol propionate cream and clobetasol 17-propionate cream was also similar with regard to success rates (89% versus 93%) and an onset of therapeutic effect within 3 days of the start of treatment (41% versus 38%). All three creams were well tolerated. Dryness of the skin and itching at the site of application were the reported adverse effects. Treatment was discontinued because of severe dryness of the skin in 1 of the 121 patients treated with halobetasol propionate cream and in 1 of the 59 patients treated with betamethasone dipropionate cream.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Betamethasone; Clobetasol; Dermatitis, Atopic; Double-Blind Method; Female; Germany, West; Glucocorticoids; Humans; Male; Middle Aged; Patient Satisfaction; Remission Induction; Vasoconstrictor Agents

In a multicenter, 14-day pediatric study in 81 evaluable patients with severe, localized corticosteroid-susceptible dermatoses, the combined treatment with halobetasol propionate cream once during the day and halobetasol propionate ointment once at night produced a very satisfactory therapeutic effect. The success rates, as indicated by ratings of "healed" and "marked improvement," were 100% and 90.9% in patients with atopic dermatitis and psoriasis vulgaris, respectively. Healing was reported in 86.8% and 72.7% of patients treated for atopic dermatitis and psoriasis, respectively. Both the cream and ointment preparations were well tolerated. Adverse effects at the site of application were reported in only 3 of 81 patients. Mild skin atrophy was observed in one patient. No systemic adverse effects were observed.

Topics: Administration, Cutaneous; Adolescent; Child; Child, Preschool; Chronic Disease; Clobetasol; Dermatitis, Atopic; Drug Tolerance; Female; Humans; Male; Ointments; Psoriasis; Remission Induction; Switzerland; Vasoconstrictor Agents; Wound Healing

The results of two studies are presented that reveal the efficacy and safety of 0.05% halobetasol ointment in the treatment of patients with plaque psoriasis of at least moderate severity. Both multicenter studies were randomized, double-blind, and vehicle controlled, and study medications were applied twice daily for 2 weeks. One study was a paired-comparison (PC); the other study was of parallel-group (PG) design. Both studies called for evaluations at entry (week 0) and after 1 and 2 weeks of treatment. The PC study enrolled 100 patients; the PG study enrolled 110 patients; 204 patients provided efficacy data over both studies. In the PC study, plaque elevation, erythema, and scaling, at least moderately severe at entry, showed at the end of treatment both statistical (p less than or equal to 0.0003) and clinical significance (all greater than 1-unit difference on the rating scale) favoring 0.05% halobetasol ointment over vehicle. Pruritus (initially mild) and total score also showed statistically significant treatment differences favoring halobetasol at the final evaluation. Patient global responses for "effectiveness" and "overall rating" favored 0.05% halobetasol ointment over vehicle. In the PG study, induration, erythema, and scaling, at least moderately severe at entry, showed at the end of treatment both statistically and clinically significant differences favoring 0.05% halobetasol ointment over vehicle. Physician's global evaluation favored 0.05% halobetasol ointment over vehicle after 2 weeks of use. No patients were released from either study because of adverse events. No systemic adverse events or findings of skin atrophy were reported in these studies. Reports of "stings" or "burns" were equally divided between halobetasol and its vehicle.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Aged; Aged, 80 and over; Clobetasol; Double-Blind Method; Female; Humans; Male; Middle Aged; Ointments; Pharmaceutical Vehicles; Psoriasis; Remission Induction; United States; Vasoconstrictor Agents; Wound Healing

The efficacy and safety of halobetasol propionate 0.05% cream, an ultra high-potency corticosteroid preparation, was evaluated in a double-blind, vehicle-controlled, paired comparison study. Patients' psoriatic lesions were evaluated before treatment and after 1 and 2 weeks of twice-daily treatment with halobetasol propionate and vehicle. Response measures (plaque elevation, erythema, scaling, and pruritus) were evaluated with a 4-point severity scale whereby the sum provided a total score. Patient self-assessment measures were obtained at the 2-week visit by categorizing his or her global responses to queries about each treatment's "effectiveness" and "overall rating." All efficacy parameters, as judged by the physician, showed statistically significant (p = 0.0001) treatment differences favoring halobetasol propionate at both week 1 and week 2 evaluations. Patient global responses for "effectiveness" and "overall rating" favored halobetasol propionate 0.05% cream over vehicle after 2 weeks of use. No systemic adverse drug effects were reported during the study. No patient was discontinued from the study because of an adverse event, and there was no evidence of skin atrophy after 2 weeks of treatment with either agent. Patient reports of "stings" or "burns" were equally distributed between the active and vehicle treatment groups. This trial demonstrates that halobetasol propionate 0.05% cream is clinically beneficial and without evidence of significant risk in the treatment of plaque psoriasis.

Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Clobetasol; Double-Blind Method; Female; Humans; Male; Middle Aged; Pharmaceutical Vehicles; Pruritus; Psoriasis; Safety; United States; Vasoconstrictor Agents

The efficacy and safety of 0.05% halobetasol propionate ointment were evaluated in patients with chronic atopic or other eczematous dermatoses in two vehicle-controlled, double-blind studies: a paired-comparison study in 124 patients (study A) and a parallel-group study in 100 patients (study B). In study A, patients applied both treatments twice daily for 2 weeks and were evaluated by investigators on days 0, 7, and 14 with 0 to 3 severity scales and by self-assessment with two 5-step end-of-treatment rating scales. In study B, patients applied treatments twice daily for 2 weeks, and investigators made evaluations on days 0, 3, 7, and 14 with 0 to 6 scales and also made a 5-step end-of-treatment physician's global assessment. In study A, both severity scores and patient ratings favored halobetasol propionate significantly on days 7 (p less than or equal to 0.0013) and 14 (p less than 0.0001); in study B, severity scores on days 3 (p less than or equal to 0.045, pruritus, erythema, and overall lesion severity), 7, and 14 (p less than 0.001, all comparisons) also favored halobetasol propionate significantly, and global assessments showed complete resolution or marked improvement for 83% of patients using halobetasol propionate versus 28% of those using vehicle (p less than 0.0001). No instances of systemic effects or skin atrophy were reported in either study. We conclude that 0.05% halobetasol propionate ointment is highly effective and well tolerated in the treatment of the conditions studied, with the rapid action and high degree of clearing associated with superpotent corticosteroid formulations.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Chronic Disease; Clobetasol; Dermatitis; Dermatitis, Atopic; Eczema; Female; Humans; Male; Middle Aged; Neurodermatitis; Ointments; Pharmaceutical Vehicles; Remission Induction; Safety; Treatment Outcome; United States; Vasoconstrictor Agents

Six investigators evaluated 0.05% halobetasol propionate cream and its vehicle in 111 patients with chronic atopic dermatitis and several other eczematous dermatoses. Patients applied treatment twice daily to bilateral lesions for 14 days. Investigators graded pruritus, erythema, scaling, papulation, and lichenification using 4-point severity scales on days 0, 7, and 14. On day 14 patients provided an assessment of efficacy for both treatments. Statistically significant differences favoring halobetasol propionate over the vehicle were seen for all signs and symptoms (p less than 0.001). Substantial improvements were achieved by the active treatment by day 7 (p less than 0.001). Patients assessments of efficacy were significantly higher for halobetasol cream than for vehicle (p less than 0.001). No instances of systemic effects or skin atrophy were reported and adverse experiences were limited to burning or stinging and other minor, nonspecific complaints distributed uniformly between active treatment and vehicle. These results demonstrate that 0.05% halobetasol propionate cream is highly effective in the treatment of atopic dermatitis and other eczematous dermatoses.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Chronic Disease; Clobetasol; Dermatitis; Dermatitis, Atopic; Double-Blind Method; Eczema; Female; Humans; Male; Middle Aged; Neurodermatitis; Patient Satisfaction; Pharmaceutical Vehicles; Remission Induction; Safety; Vasoconstrictor Agents

Copy: Palmoplantar psoriasis is a chronic, difficult-to-treat localized variant of psoriasis that affects the palms and soles, significantly affecting patient's quality of life.. To evaluate the synergistic effect of a fixed-combination topical lotion composed of halobetasol propionate 0.01% and tazarotene 0.045% in the treatment of palmoplantar psoriasis.. This was an open-label investigator-initiated trial involving 21 patients with moderate-to-severe palmoplantar plaque-type psoriasis who underwent treatment with halobetasol propionate 0.01% and tazarotene 0.045%. Subjects were assessed for disease severity using the palmoplantar Physician Global Assessment and the mean difference over time was compared using the Wilcoxon signed-rank test.. 5 patients (24%) achieved a palmoplantar Physician Global Assessment of 0 or 1 after week 24 or last observation carried forward. The mean palmoplantar Physician Global Assessment significantly decreased from baseline (3.57) to week 24/last observation carried forward (2.38) (P<0.001).. Halobetasol propionate 0.01% and tazarotene 0.045% lotion demonstrated efficacy in adult patients with moderate-to-severe palmoplantar plaque-type psoriasis through significant improvement in palmoplantar Physician Global Assessment. The complementary mechanisms of action of the corticosteroid and tazarotene may be of benefit compared to monotherapeutic agents. J Drugs Dermatol. 2023;22(2): 223-225. doi:10.36849/JDD.7067.

Topics: Adult; Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Emulsions; Humans; Nicotinic Acids; Psoriasis; Quality of Life; Severity of Illness Index; Skin Cream; Treatment Outcome

A novel topical corticosteroid, halobetasol propionate (HP) 0.01% lotion (Bryhali™), has recently been introduced for the treatment of plaque psoriasis and corticosteroid-responsive dermatoses in adults. Once daily application of HP 0.01% lotion is indicated for use up to 8 weeks. Treatment success for plaque psoriasis in the pivotal phase 3 clinical trials (defined as an Investigator Global Assessment [IGA] of clear/almost clear [IGA 0/1] with ≥2-grade improvement from baseline) occurred in over one-third of patients by week 8. Treatment-emergent adverse events were typically mild-to-moderate in intensity and usually limited to the application site(s). No treatment-related cases of skin atrophy have been reported from the studies. Counselling should be considered to optimize treatment outcomes.

Topics: Administration, Cutaneous; Adult; Clobetasol; Drug Combinations; Emollients; Emulsions; Glucocorticoids; Humans; Immunoglobulin A; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Not all patients with psoriasis achieve a satisfactory response to their initial biologic monotherapy. Switching to a new biologic may be associated with new safety issues and additional costs. In this study, we assessed the effectiveness and safety of adjunctive halobetasol propionate (HP) 0.01%-tazarotene (TAZ) 0.045% lotion in adult patients with moderate to severe plaque psoriasis who had been receiving biologic monotherapy for 24 weeks or more but had inadequate responses. All participants received HP-TAZ lotion once daily for 8 weeks, then once every other day for 4 weeks, in addition to their ongoing biologics. This real-world study demonstrated that HP-TAZ lotion adjunctive to ongoing biologics is safe and effective and potentially a more economical alternative to switching biologics for patients with psoriasis with inadequate responses to biologic monotherapy.

Topics: Administration, Cutaneous; Adult; Biological Products; Clobetasol; Dermatologic Agents; Drug Combinations; Emollients; Humans; Nicotinic Acids; Propionates; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Up to 80% of individuals with plaque psoriasis have scalp involvement, which can have a significant impact on the quality of life of affected individuals. Despite advancements in psoriasis therapeutics, management of scalp involvement remains a challenge. This12-week, open-label pilot study assessed the safety and efficacy of fixed combination tazarotene 0.045% and halobetasol propionate 0.01% lotion for the treatment of patients with mild-to-moderate plaque psoriasis with scalp involvement. Among 20 patients who were followed through 12 weeks, there were significant improvements in the primary endpoint (Investigator’s Global Assessment (IGA)) and most secondary endpoints (Psoriasis Scalp Severity Index (PSSI), body surface area (BSA), and scalp IGA (sIGA)). Treatment was well-tolerated. Further placebo-controlled double-blinded study for confirmation of our results is recommended. J Drugs Dermatol. 2021;20(11): 1191-1194. doi:10.36849/JDD.0102.

Topics: Clobetasol; Dermatologic Agents; Double-Blind Method; Drug Combinations; Humans; Nicotinic Acids; Pilot Projects; Psoriasis; Quality of Life; Scalp; Severity of Illness Index; Skin Cream; Treatment Outcome

A novel fixed combination lotion containing the super-potent corticosteroid halobetasol propionate 0.01% and retinoid tazarotene 0.045% (Duobrii™) has recently been introduced and indicated for the treatment of moderate to severe plaque psoriasis in adults. Studies have shown that there is synergy between the ingredients and that the product can be safely used intermittently for up to 1 year. Treatment success (i.e., Investigator Global Assessment [IGA] of clear/almost clear [IGA 0/1] and at least a 2-grade improvement from baseline) occurred in 58.8% of participants at some point in a 1-year clinical trial. Persistence of treatment success is common after treatment discontinuation. Most treatment-emergent adverse events are application site reactions, mild to moderate in intensity, and occur primarily during the first 12 weeks. Counselling should be considered to optimize treatment outcomes.

Topics: Administration, Cutaneous; Adult; Clobetasol; Dermatologic Agents; Drug Combinations; Humans; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream

Successful clinical data on halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis are published. This article charts its formulation development.. Dermal deposition, clinical efficacy, and synergistic effect of HP and TAZ delivered by polymeric emulsion technology was compared to HP 0.05% cream (Ultravate) and TAZ 0.1% cream (Tazorac); skin hydration and barrier maintenance with vehicle lotion through Trans Epidermal Water Loss (TEWL) and corneometry using human cadaver tissue; and steroid potency by vasoconstrictor assay (VCA) in healthy volunteers. Safety and tolerability evaluated in clinical studies and patient preference questionnaire.. HP/TAZ lotion, using polymeric emulsion technology demonstrated better active ingredient delivery than HP 0.05% or TAZ 0.1% creams; supported by synergistic clinical data, with high HP potency outcome. Efficacy was rapid and sustained posttreatment. Layering TAZ 0.1% cream onto HP 0.05% cream had a negative effect on receptor phase levels. HP/TAZ lotion provided rapid and sustained increases in skin moisturization and gradually decreases in TEWL. Most subjects responded favorably to questions on the physical attributes of the vehicle lotion.. Fixed combination HP 0.01%/TAZ 0.045% lotion formulation utilizing innovative polymeric emulsion technology and optimal selection of solvents/emollients/humectants, has recently been developed. Features inherent in technology translate into rapid, sustained efficacy, low irritation, and good patient acceptance.

Topics: Clobetasol; Dermatologic Agents; Drug Combinations; Emulsions; Humans; Nicotinic Acids; Psoriasis; Severity of Illness Index; Treatment Outcome

In recent years, calcineurin inhibitors have been used as the first line alternative to topical corticosteroids in the treatment of discoid lupus erythematosus (DLE). We aim to evaluate the efficacy and safety of topical tacrolimus 0.1% vs topical halobetasol propionate 0.05% in patients with DLE. This comparative study was carried out in the Department of Dermatology and Venereology, Chittagong Medical College Hospital (CMCH), Bangladesh between the period of July 2018 and June 2019. The change of DLE activity assessed with the cutaneous lupus erythematosus disease area and severity index was used as a primary outcome measure. The effective sample was 40 patients in each group. Both groups were similar in terms of baseline demographic and clinical characteristics. After 8 weeks of treatment, the mean total erythema score decreased significantly in both groups (in tacrolimus treated group [TTG] from 12.53 ± 8.05 to 8.03 ± 5.69, [P < .001] and in halobetasol propionate treated group [HTG] from 11.83 ± 7.17 to 7.30 ± 4.56 [P < .001]), as well as the mean total scale/hypertrophy score (in TTG from 8.08 ± 5.30 to 4.33 ± 3.21; [P < .001] and in HTG from 7.40 ± 4.73 to 3.68 ± 2.01, [P < .001]. The magnitude of reduction was significantly better in HTG [P = .032]). The mean total activity score decreased significantly in both groups (in TTG from 22.95 ± 13.40 to 14.33 ± 8.89, [P < .001] and in HTG from 22.15 ± 11.95 to 13.7 ± 7.22, [P < .001]). The present study demonstrated that tacrolimus 0.1% ointment and halobetasol propionate 0.05% ointment had a comparable efficacy in DLE patients; however, halobetasol showed significantly better improvement regarding scaly, hypertrophic lesions.

Topics: Bangladesh; Clobetasol; Humans; Hydroxychloroquine; Lupus Erythematosus, Discoid; Tacrolimus

Topics: Amyloidosis; Biopsy; Clobetasol; Drug Combinations; Humans; Male; Middle Aged; Nicotinic Acids; Skin; Skin Cream; Treatment Outcome

The aim of this research was the development and characterization of three gel dosage forms of Halobetasol propionate loaded lipid nanoparticles (HB-NLC) for the treatment of inflammatory skin diseases. A Pluronic gel (Pl-HB-NLC), a Carbopol gel (Cb-HB-NLC) and a Cremigel (Cg-HB-NLC), were characterized for stability, swelling, degradation, porosity and rheology. The biopharmaceutical behavior of in vitro release and ex vivo permeation, along with microbiological stability were also evaluated. Tolerance and therapeutic efficacy were determined in vivo. The gels proved to have eudermic pH and to be effective to improve HB-NLC stability for more than 6 months. In vitro drug release profiles were adjusted to a first order (Pl-HB-NLC, Cg-HB-NLC) and hyperbola (Cb-HB-NLC) kinetic models, revealing sustained drug release. Ex vivo biopharmaceutical behavior showed slow drug penetration through skin, delaying the drug entrance into systemic circulation. The formulations were effective in reducing inflammation with a lower drug dose in comparison with existing treatments, obtaining the fastest effect when using Pl-HB-NLC. After application of the formulations in volunteers, no irritation, redness or edema reactions were detected, plus, an enhancement of the biomechanical properties of the skin was evidenciated. Therefore, the results indicate that these formulations are a suitable alternative to current treatments.

Topics: Administration, Topical; Adult; Animals; Biological Products; Clobetasol; Dosage Forms; Drug Carriers; Drug Development; Female; Gels; Humans; Inflammation; Lipids; Male; Middle Aged; Nanostructures; Organ Culture Techniques; Rabbits; Skin Absorption; Treatment Outcome; Vasoconstrictor Agents

Skin of color patients with psoriasis face unique challenges related to disease characteristics and treatment. Dyspigmentation, including postinflammatory hypo- and hyperpigmentation, more frequently and severely affects patients with skin of color and remains a challenge in psoriasis management. We present the case of a 58-year-old Black male with moderate psoriasis who was treated for 8 weeks with a fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion during a phase 3 study (NCT02462070). HP/TAZ was efficacious in this patient, whose Investigator’s Global Assessment score decreased from 3 (moderate) at baseline to 1 (almost clear) within 4 weeks, with maintenance of & "almost clear"; through week 12 (4 weeks posttreatment). Affected body surface area decreased by 50% and quality of life greatly improved from baseline to week 8. The patient experienced dyspigmentation of the affected skin during the trial; hypopigmentation was primarily experienced from weeks 2-8, with the greatest degree at week 4. By week 12, the affected skin area had returned to normal, with only small regions of hyperpigmentation, primarily around the periphery of the lesion. These results indicate that HP/TAZ may be a treatment option for patients with skin of color, who are disproportionally affected by postinflammatory dyspigmentation. \ \ J Drugs Dermatol. 2020;19(10):1000-1004. doi:10.36849/JDD.2020.5347.

Topics: Administration, Cutaneous; Black or African American; Clobetasol; Drug Combinations; Esthetics; Humans; Hypopigmentation; Male; Middle Aged; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Skin Pigmentation; Treatment Outcome

Topics: Betamethasone; Calcitriol; Clobetasol; Humans; Nicotinic Acids; Psoriasis

Topics: Betamethasone; Calcitriol; Clobetasol; Humans; Nicotinic Acids; Psoriasis

In 2019, the FDA approved several new drugs for use in primary care. This article highlights the following new drugs: risankizumab-rzaa (Skyrizi); halobetasol and tazarotene (Duobrii); dolutegravir and lamivudine (Dovato); romosozumab-aqqg (Evenity); brexanolone (Zulresso); solriamfetol (Sunosi); aclidinium and formoterol (Duaklir Pressair); and siponimod (Mayzent).

Topics: Antibodies, Monoclonal; Azetidines; Benzyl Compounds; beta-Cyclodextrins; Carbamates; Clobetasol; Drug Approval; Drug Combinations; Formoterol Fumarate; Heterocyclic Compounds, 3-Ring; Humans; Lamivudine; Nicotinic Acids; Oxazines; Phenylalanine; Piperazines; Pregnanolone; Pyridones; Tropanes; United States; United States Food and Drug Administration

Recently, clinical data on 8 weeks’ once-daily treatment of localized moderate-to-severe psoriasis with a novel fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion were published.1,2 HP/TAZ lotion was significantly more effective than individual active ingredients or vehicle, based on improvements in Investigator’s Global Assessment (IGA), body surface area (BSA) involvement, and signs and symptoms of psoriasis (erythema, plaque elevation, and scaling) at the target lesion as well as a synergistic benefit over individual active ingredients, and good tolerability.

Topics: Administration, Cutaneous; Clinical Trials, Phase III as Topic; Clobetasol; Dermatologic Agents; Drug Administration Schedule; Drug Combinations; Humans; Multicenter Studies as Topic; Nicotinic Acids; Psoriasis; Severity of Illness Index; Skin Cream; Treatment Outcome

Topics: Administration, Cutaneous; Clobetasol; Dermatologic Agents; Drug Combinations; Humans; Nicotinic Acids; Psoriasis

Halobetasol propionate (HB) is considered a super potent drug in the group of topical corticosteroids. HB has anti-inflammatory activity, vasoconstriction properties, and due to its high skin penetration, it can cause systemic side effects. To improve its characteristics, enhance topical effectiveness and reduce penetration to systemic circulation, a study to optimize and characterize a HB-loaded lipid nanocarrier (HB-NLC) has been made by high-pressure homogenization method. The formulation is composed by HB, surfactant, glyceryl distearate and capric glycerides. The optimized HB-NLC containing 0.01% of HB and 3% of total lipid shows an average size below 200 nm with a polydispersity index ≪0.2 and an encapsulation efficiency ≫90%. The in vitro and in vivo tests indicate that the HB-NLC is not toxic, is well tolerated and has an anti-inflammatory effect because they decrease the production of Interleukins in keratinocytes and monocytes. HB-NLC is considered an alternative treatment for skin inflammatory disorders.

Topics: Administration, Cutaneous; Animals; Anti-Inflammatory Agents; Cell Death; Clobetasol; Drug Carriers; Female; Humans; Lipids; Male; Nanostructures; Rabbits; THP-1 Cells; Treatment Outcome

Halobetasol propionate (HB) is a potent synthetic corticosteroid used against inflammatory skin diseases, such as dermatitis, eczema, and psoriasis, among others. The aim of this study is to define how the presence of different skin penetration enhancers (nonane, menthone, limonene, azone, carene, decanol, linoleic acid and cetiol) affects the penetration and retention in skin of HB. To determine drug penetration through skin, 5% of each promoter was used in an ex vivo system with human skin on Franz cells. The results showed that the highest permeation occurs in the presence of menthone, followed by nonane. Permeation parameters were determined. The in vivo test was assessed, and the formulation containing HB-menthone presented better anti-inflammatory efficacy. These results are useful to generate a specific treatment according to each patient's needs, and the inflammatory characteristics of the disease.

Topics: Administration, Cutaneous; Anti-Inflammatory Agents; Chromatography, High Pressure Liquid; Clobetasol; Humans; Permeability; Reproducibility of Results; Skin Absorption

A novel, sensitive, stability-indicating, gradient, reverse-phase high-performance liquid chromatographic method has been developed for quantitative determination of halobetasol propionate and its impurities in topical dosage forms. The chromatographic separation was achieved on a Phenomenex Synergi polar reverse phase, 250 × 4.6 mm, 4 µm column. Mobile phase A comprises a mixture of 0.01 M KH2PO4 buffer containing 0.2% 1-octane sulfonic acid sodium salt (pH 3.0), acetonitrile and methanol in the ratio 80:15:05 (v/v/v), respectively, and mobile phase B contains a mixture of 0.01 M KH2PO4 buffer containing 0.2% 1-octane sulfonic acid sodium salt (pH 3.0), acetonitrile and methanol in the ratio 20:70:10 (v/v/v), respectively. The flow rate is 0.8 mL min(-1). The column compartment temperature is set at 40°C and the detection wavelength is set at 240 nm. The resolutions between Halobetasol propionate and all the impurities are >2.0 for all pairs of compounds. The drug product was subjected to International Conference on Harmonization (ICH)-prescribed hydrolytic, oxidative, photolytic and thermal stress conditions. The method is validated as per the ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision, robustness and ruggedness.

Topics: Chromatography, High Pressure Liquid; Clobetasol; Dosage Forms; Drug Contamination; Drug Stability

A simple, short and stability-indicating reverse phase-ultra-performance liquid chromatography method was developed and validated for the quantitative determination of related impurities of halobetasol propionate in halobetasol propionate 0.05% cream formulation. The proposed method was developed on an ACQUITY UPLC™ BEH Phenyl (2.1 × 100 mm, 1.7 µm) column at 40°C with a mobile phase containing a gradient mixture of potassium hydrogen phosphate buffer and acetonitrile and methanol as modifiers with a runtime of 13.0 min at a monitored wavelength of 242 nm. A simple preparative method and liquid chromatography-mass spectrometry-compatible UPLC method also were developed for the isolation and identification of impurities and degradation products. The drug was subjected to forced-degradation conditions and found to degrade significantly. The stability-indicating capability of the developed method is established by analyzing forced-degradation samples in which the spectral purity of halobetasol propionate is ascertained along with the separation of degradation products from the analyte peak. The developed method was validated as per International Conference on Harmonization guidelines. The developed method is precise (%relative standard deviation <2.0) and is capable of detecting and quantifying all the six impurities at a level of 0.01 and 0.03%, respectively, with respect to test concentration. The wide linearity range, sensitivity, accuracy, short retention time and simple mobile phase imply that the method is suitable for routine quantification of halobetasol propionate and its related substances.

Topics: Chromatography, High Pressure Liquid; Chromatography, Reverse-Phase; Clobetasol; Drug Contamination; Drug Stability; Limit of Detection; Skin Cream

The clinical use of halobetasol propionate (HP) is related to some adverse effects like irritation, pruritus and stinging. The purpose of this work was to construct HP-loaded solid lipid nanoparticles (HP-SLN) formulation with skin targeting to minimizing the adverse side effects and providing a controlled release. HP-SLN were prepared by solvent injection method and formula was optimized by the application of 3(2) factorial design. The nanoparticulate dispersion was evaluated for particle size and entrapment efficiency (EE). Optimized batch was characterized for differential scanning calorimetry (DSC), scanning electron microscopy, X-ray diffraction study and finally incorporated into polymeric gels of carbopol for convenient application. The nanoparticulate gels were evaluated comparatively with the commercial product with respect to ex-vivo skin permeation and deposition study on human cadaver skins and finally skin irritation study. HP-SLN showed average size between 200 nm and 84-94% EE. DSC studies revealed no drug-excipient incompatibility and amorphous dispersed of HP in SLN. Ex vivo study of HP-SLN loaded gel exhibited prolonged drug release up to 12 h where as in vitro drug deposition and skin irritation studies showed that HP-SLN formulation can avoid the systemic uptake, better accumulative uptake of the drug and nonirritant to the skin compared to marketed formulation. These results indicate that the studied HP-SLN formulation represent a promising carrier for topical delivery of HP, having controlled drug release, and potential of skin targeting with no skin irritation.

Topics: Administration, Cutaneous; Animals; Calorimetry, Differential Scanning; Clobetasol; Crystallography, X-Ray; Dermatitis, Irritant; Diffusion; Drug Stability; Gels; Humans; Liposomes; Microscopy, Electron, Scanning; Monoglycerides; Nanoparticles; Particle Size; Rabbits; Skin Absorption

Porokeratosis is a disorder of clonal hyperproliferation of keratinocytes with several different clinical manifestations. Cutaneous lesions vary in their appearance and distribution. All variants share the distinguishing cornoid lamella on histopathological examination. We present an unusual case of disseminated porokeratosis of Mibelli in an immunocompetent patient.

Topics: Abdomen; Aged; Arm; Biopsy; Buttocks; Clobetasol; Dermatologic Agents; Groin; Humans; Immunocompetence; Leg; Male; Organ Specificity; Porokeratosis; Pruritus

In a previous study of experimental murine encephalitis induced by Junín virus (JV), an arenavirus, we showed increased expression of iNOS by unidentified cells, concomitant with the astrocyte reaction. The specific inhibition of iNOS was associated with greater mortality but lower astrocytosis, suggesting that the protective role of nitric oxide (NO) synthesized by iNOS was related to enhanced astrocyte activation, representing a beneficial cellular response to virus-induced central nervous system damage. In the present work, cultured astrocytes were used to study whether JV infection could trigger iNOS expression and assess its eventual relationship with viral replication, glial fibrilary acidic protein (GFAP) expression levels and the presence of apoptosis. We found that JV infection of astrocytes did not induce apoptosis but produced both increased iNOS synthesis, detected by immunocytochemistry and fluorescence activated cell sorting (FACS) analysis, and increased NO, which was indirectly measured by nitrite/nitrate levels. These changes occurred early relative to the increases in GFAP expression, as detected by immunocytochemistry, FACS analysis and RT-PCR. The fact that iNOS inhibition abolished enhanced GFAP expression in infected monolayers suggests that NO was directly involved. In addition, iNOS inhibition enhanced virus replication. Together with data from confocal microscopy, these results suggest that JV induces iNOS expression in infected astrocytes and that the resulting NO has an important role both in reducing viral replication and in enhancing subsequent astrocyte activation.

Topics: Animals; Animals, Newborn; Astrocytes; Brain; Cells, Cultured; Clobetasol; Enzyme Inhibitors; Flow Cytometry; Gene Expression Regulation, Viral; Glial Fibrillary Acidic Protein; Junin virus; Lysine; Mice; Mice, Inbred BALB C; Nitric Oxide Synthase Type II; Virus Replication

Topics: Clobetasol; Dermatologic Agents; Eczema, Dyshidrotic; Female; Hand; Humans; Middle Aged; Recurrence

Degradation of halobetasol propionate was observed in the presence of bases. A single cyclization product was isolated and fully characterized by MS, NMR and X-ray crystallography.

Topics: Catalysis; Clobetasol; Crystallography, X-Ray; Cyclization; Magnetic Resonance Spectroscopy; Models, Molecular; Vasoconstrictor Agents

Sebaceous hyperplasia is a cutaneous lesion consisting of soft, yellow, papular lesions usually occurring on the face in elderly patients. The occurrence of the lesion on the vulva is exceptionally rare. We were able to identify only three cases reported in the literature. We report a case of sebaceous hyperplasia of the vulva with an unusual presentation.

Topics: Administration, Topical; Biopsy; Clobetasol; Diagnosis, Differential; Female; Humans; Hyperplasia; Middle Aged; Sebaceous Glands; Vasoconstrictor Agents; Vulva

Two spectrophotometric procedures are described for the determination of clobetasol propionate(I), halobetasol propionate(II) (corticosteroids) and quinagolide hydrochloride(III) (prolactin inhibitor). For corticosteroid drugs, the procedures are based on the formation of phenyl hydrazones of the corticosteroids which are subsequently subjected to charge transfer complexation reaction with either 2,3-dichloro-5,6-dicyanobenzoquinone (DDQ) as pi-acceptor or with iodine as sigma-acceptor. Prolactin inhibitor was reacted directly with the previous reagents. The molar ratios of the reactants were established and the experimental conditions were studied giving maximum absorption at 588 and 290 nm with DDQ and iodine methods, respectively for the three drugs. The concentration ranges were 20-150,50-300, and 20-80 microg ml(-1) in DDQ method for (I), (II), and (III), respectively and 13-20,15-40, and 8-32 microg ml(-1) in iodine method for (I), (II) and (III), respectively.

Topics: Aminoquinolines; Clobetasol; Drug Stability; Sensitivity and Specificity; Spectrophotometry

Tazarotene is the first receptor-selective retinoid indicated for the topical treatment of plaque psoriasis. It is being used clinically in combination with other topical antipsoriatic treatments, although its stability in the presence of these products has not been examined extensively. This study examines the compatibility of tazarotene 0.05% gel with 17 other topical products used in the treatment of psoriasis, assessed over a 2-week period. Tazarotene showed minimal degradation (<10%) at 0, 8, 24, and 48 hours after compounding with each of the 17 products. In addition, after 1 and 2 weeks, degradation of tazarotene remained less than 10% for 15 of the 17 products tested. Tazarotene appeared to have minimal impact on the stability of the other products. These results suggest that tazarotene gel can be successfully coprescribed with a range of commonly used topical psoriasis treatments without adversely affecting the chemical stability of either agent.

Topics: Administration, Topical; Betamethasone; Calcitriol; Clobetasol; Dermatologic Agents; Drug Evaluation, Preclinical; Drug Incompatibility; Fluocinonide; In Vitro Techniques; Mometasone Furoate; Nicotinic Acids; Pregnadienediols; Psoriasis

To determine the effectiveness of topical corticosteroids in the management of mycosis fungoides.. Prospective study.. Academic referral center, Veterans Affairs Medical Center, and private practice.. Seventy-nine patients with patch or plaque stage of mycosis fungoides. Fifty-one were stage T1 (less than 10% of skin involved) and 28 were stage T2 (10% or more of skin involved). Seventy-five had patch-stage and 4 had plaque-stage disease as determined by histological examination.. Patients were treated with topical class I to III corticosteroids. Of the stage T1 patients, all used class I corticosteroids, and 4 (8%) also used class II or III corticosteroids. Of the stage T2 patients, 19 (68%) used class I and 12 (43%) used class II or III compounds. Some patients used more than 1 class of corticosteroid. Applications were almost always twice daily. Three stage T1 and 2 stage T2 patients used plastic film occlusion. Baseline and monthly morning serum cortisol levels were obtained during treatment.. Response to treatment and side effects.. The median follow-up period was 9 months. Thirty-two (63%) of stage T1 patients achieved complete remission and 16 (31%) achieved partial remission, for a total response rate of 48 (94%). The comparable figures for stage T2 patients were 7 (25%), 16 (57%), and 23 (82%), respectively. Responses were determined by clinical examination. Thirty-nine patients achieved clinical clearing. In 7 of these, posttreatment biopsy specimens were obtained, and all showed histological clearing. Reversible depression of serum cortisol levels occurred in 10 (13%). Minor skin irritation occurred in 2 patients and localized, reversible skin atrophy in 1.. Topical corticosteroids, especially class I compounds, are an effective treatment for patch-stage mycosis fungoides.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Antineoplastic Agents; Betamethasone; Betamethasone Valerate; Clobetasol; Drug Administration Schedule; Female; Fluocinonide; Follow-Up Studies; Humans; Hydrocortisone; Male; Middle Aged; Mycosis Fungoides; Neoplasm Staging; Occlusive Dressings; Prospective Studies; Remission Induction; Skin Neoplasms; Treatment Outcome; Triamcinolone Acetonide

Topics: Administration, Cutaneous; Adult; Clobetasol; Eyelid Diseases; Facial Dermatoses; Female; Humans; Nose Diseases; Sarcoidosis; Skin Diseases

Topics: Clobetasol; Humans; Skin Diseases; Vasoconstrictor Agents

Topics: Administration, Topical; Androstadienes; Anti-Inflammatory Agents; Clinical Trials as Topic; Clobetasol; Drugs, Generic; Fluticasone; Glucocorticoids; Humans; Pharmaceutical Vehicles; Vasoconstriction

The effects on the hypothalamic-pituitary-adrenal axis of the ultra-high potency corticosteroid halobetasol in the treatment of psoriasis were evaluated in seven patients with extensive, long-standing plaque psoriasis. Each patient applied 3.5 g halobetasol 0.05% ointment in the morning and evening for 7 days. Morning plasma cortisol levels and 24-hour urinary excretion of 17-hydroxycorticosteroid were determined before and on the last 2 days of treatment; plasma cortisol levels were also determined 4 and 5 days after completion of therapy. Morning plasma cortisol concentrations did not decrease significantly during treatment, and no values were below the normal range. Mean 24-hour urinary 17-hydroxycorticosteroid excretion fell from 6.6 +/- 1.4 mg to 5.1 +/- 1.4 mg. Two patients had mild, localized pruritus and stinging with the initial ointment application. No other adverse cutaneous effects were observed. Halobetasol was also clinically efficacious over the 7 days of treatment, based on evaluation of pruritus, erythema, scaling, and plaque elevation. These results demonstrate no adverse effects of the drug on the hypothalamic-pituitary-adrenal axis at doses that are clinically effective in the management of plaque psoriasis.

Topics: 17-Hydroxycorticosteroids; Adult; Aged; Betamethasone; Clobetasol; Drug Evaluation; Female; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Male; Middle Aged; Ointments; Pituitary-Adrenal System; Psoriasis; Time Factors

Topics: Administration, Cutaneous; Betamethasone; Clobetasol; Drug Administration Schedule; Facial Dermatoses; Female; Humans; Male; Ointments; Vitiligo