halobetasol and Dermatitis--Atopic

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

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 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