pep005 and Facial-Dermatoses

This systematic review compared the relative efficacy of 5-fluorouracil 0.5% in salicylic acid 10% (5-FU/SA), ingenol mebutate (IMB) and imiquimod 2.5%/3.75% (IMI) for actinic keratosis on the face, forehead or scalp. Only 11 publications, relating to 7 randomised controlled trials, met inclusion criteria and it was only possible to compare the effect of all 3 treatments on complete clinical clearance, and the effect of 5-FU/SA and IMB on actinic keratosis recurrence rate. Despite a higher vehicle response rate for 5-FU/SA, complete clinical clearance was higher than IMB and IMI (55.4, 42.2, and 25.0-30.6/34.0-35.6%, [corrected] respectively). 5-FU/SA was also associated with lower actinic keratosis recurrence rate than IMB at 12 months post-treatment (32.7 vs. 53.9%). Although qualitative assessment suggested a numerical advantage of 5-FU/SA over IMB and IMI in terms of complete clinical clearance and sustained clearance, clinical data from longer term trials, with comparable outcome measures, are required to corroborate these findings.

Topics: Administration, Cutaneous; Aminoquinolines; Dermatologic Agents; Diterpenes; Drug Combinations; Facial Dermatoses; Fluorouracil; Humans; Imiquimod; Keratosis, Actinic; Randomized Controlled Trials as Topic; Salicylic Acid; Scalp Dermatoses; Skin; Treatment Outcome

Ingenol mebutate (IngMeb) 0.015% or 0.05% is approved for actinic keratosis (AK) areas of 25 cm. To determine efficacy and safety of IngMeb 0.027% in areas of AK of up to 250 cm. This phase 3, randomized, double-blind, vehicle-controlled trial (NCT02361216) enrolled adult patients with 5 to 20 AK lesions on the face/scalp (25-250 cm. IngMeb was superior to vehicle for complete AK clearance (21.4% vs 3.4%, P < .001) and AK clearance of 75% or greater (59.4% vs 8.9%, P < .001) at week 8. Probability of sustained clearance during the 12-month follow-up was 22.9% for patients treated with IngMeb. Increased treatment satisfaction and cosmetic outcomes were observed with IngMeb versus vehicle. No unexpected safety signals were identified.. Localized skin responses hindered maintenance of double-blinding.. IngMeb 0.027% was superior to vehicle for treatment of AK areas of up to 250 cm

Topics: Adult; Aged; Aged, 80 and over; Diterpenes; Double-Blind Method; Facial Dermatoses; Female; Gels; Humans; Keratosis, Actinic; Male; Middle Aged; Scalp Dermatoses; Thorax; Treatment Outcome

Ingenol mebutate (IngMeb) and diclofenac sodium (DS) are approved treatments for actinic keratosis (AK).. To compare the efficacy and safety of IngMeb 0·015% gel with DS 3% gel (NCT02406014).. Patients with 4-8 visible, discrete AK lesions on the face/scalp in a 25 cm. AKCLEAR 100 at end of first treatment course was higher with IngMeb (34%) vs. DS (23%; P = 0·006). AKCLEAR 100 at end of last IngMeb course (53%) and Week 17 (45%) was higher than DS (both P < 0·001). The most frequent AE was application-site erythema (IngMeb 19%; DS 12%). Treatment-related AE (TRAE) duration was shorter with IngMeb. TRAE withdrawals were lower for IngMeb (2%) vs. DS (6%). TSQM scores for global satisfaction (P < 0·001) and effectiveness (P = 0·002) were higher with IngMeb, as was dosing instruction adherence (≥ 90% vs. 70%).. AKCLEAR 100, patient treatment satisfaction and effectiveness were significantly higher with IngMeb compared with DS, demonstrating superiority of IngMeb for AK treatment on face/scalp.

Topics: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Dermatologic Agents; Diclofenac; Diterpenes; Drug Administration Schedule; Facial Dermatoses; Female; Gels; Humans; Keratosis, Actinic; Male; Middle Aged; Scalp Dermatoses; Treatment Outcome

Ingenol mebutate gel is a novel, field-directed topical treatment for actinic keratosis (AK). Most pivotal studies have targeted Western populations. No clinical study has been conducted to investigate its efficacy and safety in Asian populations.. To evaluate the efficacy and safety of ingenol mebutate gel for treating AK of face/scalp and trunk/extremities in a large Asian (Korean) population.. In this multicentre, open-label, interventional, parallel-group, prospective phase IV study (PERFECT, trial registration no.: NCT02716714), the eligible patients were allocated into either the face/scalp or the trunk/extremities group, according to their selected treatment area location. After application of ingenol mebutate gel, the participants were followed up for 6 months. The primary efficacy endpoint was complete clearance (CC) of AK lesions in the selected treatment area at day 57. Quality of life was evaluated using Skindex-29. Safety endpoints included local skin responses, scar, pigmentation, pain and adverse events.. In total, 78·1% [95% confidence interval (CI) 66·86-86·92%] of subjects had CC at day 57, with 76·6% (95% CI 64·31-86·25%) in the face/scalp group and 88·9% (95% CI 51·75-99·72%) in the trunk/extremities group. Among them, CC was sustained in 88·9% (48 of 54, 95% CI 77·37-95·81%) at month 6. The local skin responses significantly increased 1 day after the treatment compared with baseline, and decreased afterwards. Among the total subjects, 7·8% (6 of 77) had hyperpigmentation on the application area. Scars were not reported.. Ingenol mebutate is effective for the treatment of AK in Asians, with tolerable safety profiles.

Topics: Administration, Topical; Adult; Aged; Aged, 80 and over; Diterpenes; Extremities; Facial Dermatoses; Female; Follow-Up Studies; Humans; Hyperpigmentation; Keratosis, Actinic; Male; Middle Aged; Prospective Studies; Quality of Life; Republic of Korea; Scalp Dermatoses; Torso; Treatment Outcome

Daylight-photodynamic therapy (D-PDT) and ingenol mebutate (IM) are novel therapies directed to actinic keratoses (AK). The purpose of our study was to compare effectiveness, tolerability, cosmetic outcome and patient preference of D-PDT versus IM in the treatment of grade I and II AK. Twenty-seven patients with AK on the face or scalp were enrolled. Each patient received, in a 25 cm(2) target area, D-PDT on right side and IM on left side. Overall 323 AK were treated. Both target areas achieved complete response in 40.47% of the cases and average AK clearance rate was similar for D-PDT and IM (p=0.74). In D-PDT areas mean grade II AK clearance rate was lower compared with that of grade I AK (p=0.015). In IM areas grade I and II AK average clearance rates were similar (p=0.28). At week 1 and month 1, mean local skin responses (LSR) score were higher in areas treated with IM. IM areas showed more severe pain and cosmetic sequelae. D-PDT had similar effectiveness to IM, even if IM demonstrated higher grade II AK clearance rate. Tolerability profile was superior for D-PDT in terms of LSR and pain. D-PDT was more cosmetically acceptable. Patients preferred D-PDT to IM in most cases.

Topics: Aged; Aged, 80 and over; Aminolevulinic Acid; Dermatologic Agents; Diterpenes; Facial Dermatoses; Female; Humans; Keratosis, Actinic; Male; Middle Aged; Patient Preference; Photochemotherapy; Photosensitizing Agents; Remission Induction; Scalp Dermatoses; Sunlight; Surveys and Questionnaires; Time Factors; Treatment Outcome

Ingenol mebutate (IngMeb) is approved for treatment of actinic keratoses (AK) and may cause unpredictable local skin responses (LSR).. We sought to investigate whether IngMeb-induced LSR, pain, and pruritus could be alleviated with a topical glucocorticoid and, further, to assess efficacy, cosmetic outcome, and patient satisfaction in patients with severe photodamage.. In this blinded, randomized controlled clinical trial, patients with multiple AK and field cancerization of the face or scalp were treated in 2 areas with IngMeb (0.015%) daily for 3 days. After finalized IngMeb treatment, 1 area was randomized to receive topical clobetasol propionate (0.05%) twice daily for 4 days. Assessments included LSR (0-24; days 1, 4, 8, 15, 57), pain (0-10) and pruritus (0-3; days 1-15), AK clearance (days 15, 57), and cosmetic outcome (0-3; day 57).. Clobetasol propionate application had no influence on LSR (P = .939), pain (P = .500), pruritus (P = .312), or AK cure rate (P = .991). Overall, IngMeb cleared 86% of all AK lesions, exerting a therapeutic effect on all AK severity grades; cure rates were 88%, 70%, and 60% for grade I, II, and III AK, respectively. Skin texture improved significantly in remedied areas (2.0 vs 1.0; P < .001); no hypopigmentation, hyperpigmentation, or scarring were observed.. These results do not provide safety and efficacy beyond 2 months of follow-up.. Application of clobetasol propionate does not alleviate IngMeb-induced LSR after 3 days of IngMeb treatment.

Topics: Administration, Topical; Adrenal Cortex Hormones; Aged; Aged, 80 and over; Clobetasol; Denmark; Diterpenes; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Facial Dermatoses; Female; Follow-Up Studies; Gels; Humans; Keratosis, Actinic; Male; Middle Aged; Pain; Pruritus; Risk Assessment; Scalp Dermatoses; Severity of Illness Index; Single-Blind Method; Treatment Outcome

Daylight photodynamic therapy with methyl aminolaevulinate (dlPDT) and ingenol mebutate gel (IMB) are approved therapeutic options for multiple actinic keratoses (AKs). The aim of this comparative, intra-patient, split-face, randomized clinical trial was to compare treatment outcomes of dlPDT and IMB.. Two symmetrical contralateral areas of 25cm. 22 patients with a total of 311 AKs were enrolled. The mean pain VAS score was 3.55±1.82 with IMB and 2.05±0.72 with dlPDT (p<0.01). The mean LSR score was 9.91±4.24 and 4.59±4.03 (p<0.01), respectively. The mean days necessary for wound closure were 9.45±3.51 and 4.36±1.18days (p<0.01), respectively. After 3 months, 119 lesions with IMB and 120 lesions with dlPDT were healed and the CR rate with IMB (75.8%) was non-inferior to the CR rate with dlPDT (77.9%). The comparisons of CR rates of grade I and II AKs did not show any inferiority for one treatment compared to the other. Eight patients (36.4%) had all lesions cleared with IMB and 7 (31.8%) with dlPDT (p=NS). The cosmetic outcome was better with dlPDT and 17 patients evaluated dlPDT as their preferred treatment.. A 3days' treatment cycle with IMB and a single session of dlPDT had a similar efficacy for both grade I AKs and grade II AKs but dl PDT showed lower pain and inflammation scores, quicker wound closure, better cosmetic outcome and higher patients' preference.

Topics: Aged; Aged, 80 and over; Aminolevulinic Acid; Diterpenes; Dose-Response Relationship, Drug; Dose-Response Relationship, Radiation; Drug Administration Schedule; Facial Dermatoses; Female; Gels; Humans; Keratosis, Actinic; Male; Middle Aged; Patient Preference; Photochemotherapy; Scalp Dermatoses; Treatment Outcome

Photodynamic therapy with methyl aminolevulinate (MAL-PDT) and ingenol mebutate gel (IMB) are approved therapeutic options for multiple actinic keratoses (AKs).. The aim of this intraindividual, split-face, randomized clinical trial was to compare treatment outcomes of MAL-PDT and IMB.. Two symmetrical contralateral areas with a similar number of AKs were selected and randomly assigned to 3 days of an IMB treatment cycle or a single session of MAL-PDT. The next day, the local skin reaction (LSR) score was registered. The patients scored pain and time to healing of the treatment area.. After 90 days, the complete remission rate of lesions, the number of patients with complete remission of all lesions, cosmetic outcome, and patient preference were assessed.. According to our results, IMB and MAL-PDT had a similar efficacy, but the cosmetic outcome was superior with MAL-PDT. Pain was higher with PDT, but LSR was more severe and time to healing was longer with IMB. Patients preferred MAL-PDT.

Topics: Administration, Topical; Aged; Aged, 80 and over; Aminolevulinic Acid; Diterpenes; Face; Facial Dermatoses; Female; Follow-Up Studies; Gels; Humans; Keratosis, Actinic; Male; Middle Aged; Photochemotherapy; Photosensitizing Agents; Remission Induction; Retrospective Studies; Scalp; Scalp Dermatoses; Skin; Treatment Outcome

Five per cent 5-fluorouracil (5-FU) cream is a well-established treatment for actinic keratosis (AK), and ingenol mebutate gel (IMB) is a novel topical field-directed therapy.. To compare the tolerability and safety of IMB with that of 5-FU for the treatment of facial AK.. An open-label, prospective, randomized, controlled clinical trial with 100 patients with AKs within a 25-cm(2) contiguous field on the face was conducted. IMB was applied daily for three consecutive days. 5-FU was applied twice a day for 4 weeks. The treatment effect and the adverse events were evaluated at baseline and on days 2, 3, 4, 8, 15, 22, 29, 36 and 43 for intent-to-treat populations.. The mean (± SD) maximum local skin reactions (LSR) for patients treated with IMB was 10.85 (± 3.12), compared with 10.86 (± 3.55) for those who received 5-FU. Patients in the IMB group presented LSR that peaked at day 4 and almost completely regressed after 15 days. Differently, in the 5-FU group, the LSR peaked at day 29 and lasted until visit 36. Additionally, the area under the curve (LSR × visit) was significantly smaller for IMB. No differences between the treatments for pruritus, pain, tearing, conjunctival hyperaemia or headaches were noted, but the eyelid oedema rate was higher for IMB group. No significant difference in the proportion of dropouts was observed between groups. Both treatments demonstrated a suitable safety profile.. For treating AKs, the local skin reactions in the IMB group were more short-lived compared with those of 5-FU, but both treatments seemed to be safe and tolerable.

Topics: Administration, Topical; Diterpenes; Drug Tolerance; Facial Dermatoses; Fluorouracil; Follow-Up Studies; Gels; Humans; Immunosuppressive Agents; Keratosis, Actinic; Prospective Studies; Time Factors; Treatment Outcome

Actinic keratoses (AKs) are precursors to invasive squamous cell carcinoma and can progress if untreated. Limited data support the use of ingenol mebutate to treat AKs on more than one area of the body simultaneously.. To investigate safety, efficacy and treatment satisfaction when treating separate areas simultaneously or sequentially with different concentrations of ingenol mebutate gel.. In this phase IIIb study (NCT01787383), patients with clinically visible, non-hyperkeratotic AKs on two separate treatment areas (face/scalp and trunk/extremities) were randomized to simultaneous or sequential treatment with ingenol mebutate gel (0.015% and 0.05%). Endpoints included composite local skin response (LSR) score 3 days after first application, complete AK clearance and percentage reduction in AKs at week 8.. There were no statistically significant differences between simultaneous (n = 101) and sequential (n = 98) groups in composite LSR score (10.4 vs. 9.7), complete clearance (52.7% vs. 46.9%) or percentage reduction in AKs (83.4% vs. 79.1%). Mean composite LSR scores on face/scalp and trunk/extremities were similar for both groups. Adverse event (AE) incidence was comparable between groups, the most common treatment-related AEs being pruritus and pain at the application site.. Treating AKs with ingenol mebutate simultaneously or sequentially gave similar results in terms of tolerability (LSR score, AEs) and efficacy (complete clearance). Therefore, the physician and patient can select the most convenient treatment regimen, with confidence in achieving a similar outcome.

Topics: Aged; Antineoplastic Agents; Diterpenes; Extremities; Facial Dermatoses; Female; Gels; Humans; Keratosis, Actinic; Male; Patient Satisfaction; Scalp Dermatoses; Torso; Treatment Outcome

This randomized, 3-group study compared the efficacy and tolerability of 3 treatment modalities for facial actinic keratoses.. Twenty-four healthy adult male and female subjects who had 4 to 8 clinically visible and discrete actinic keratoses on the face in a contiguous 25cm2 treatment area. Subjects were randomized into one of three treatment groups: 2 treatments with 5-aminolevulinic acid (ALA) and photodynamic therapy (PDT), 1 ALA-PDT treatment and 1 course of ingenol mebutate (ingenol mebutate) 0.015% gel daily for 3 consecutive days, or 1 course of ingenol mebutate gel alone. Actinic keratoses in the treatment field were counted at the baseline visit, and at the completion of the study (day 57 or day 71). At the site of application, local site reactions were graded at each visit.. Subjects in the two ALA-PDT treatment group had a 97.5% mean reduction (P<0.00001) from the number of baseline actinic keratosis; ALA-PDT plus ingenol mebutate gel group had an 86.7% mean reduction (P<0.00001); while subjects in the ingenol mebutate gel alone group had a 91.7% mean reduction from the number of baseline actinic keratoses. The peak composite LSR score was 4.625 for the ALA-PDT group, 10.375 for the ALA-PDT followed by ingenol mebutate gel group, and 12.625 for the ingenol mebutate gel alone group (P=0.0004 and 0.001, respectively).. ALA-PDT, ingenol mebutate gel, and a combination of the two treatment modalities are successful topical therapies for the reduction of actinic keratoses on the face. The group of subjects receiving 2 consecutive treatments with ALA-PDT, compared to treatment with ingenol mebutate gel alone or sequentially after one course of ALA-PDT had a significantly lower mean composite LSR score and a non-significant trend for greater efficacy.

Topics: Administration, Cutaneous; Adult; Aminolevulinic Acid; Dermatologic Agents; Diterpenes; Facial Dermatoses; Female; Follow-Up Studies; Gels; Humans; Keratosis, Actinic; Male; Photochemotherapy; Photosensitizing Agents; Treatment Outcome

Actinic keratosis is a common precursor to sun-related squamous-cell carcinoma. Treating actinic keratoses and the surrounding skin area (i.e., field therapy) can eradicate clinical and subclinical actinic keratoses. Topical field therapy currently requires weeks or months of treatment. We investigated the efficacy and safety of a new topical field therapy for actinic keratosis, ingenol mebutate gel (0.015% for face and scalp and 0.05% for trunk and extremities).. In four multicenter, randomized, double-blind studies, we randomly assigned patients with actinic keratoses on the face or scalp or on the trunk or extremities to receive ingenol mebutate or placebo (vehicle), self-applied to a 25-cm(2) contiguous field once daily for 3 consecutive days for lesions on the face or scalp or for 2 consecutive days for the trunk or extremities. Complete clearance (primary outcome) was assessed at 57 days, and local reactions were quantitatively measured.. In a pooled analysis of the two trials involving the face and scalp, the rate of complete clearance was higher with ingenol mebutate than with placebo (42.2% vs. 3.7%, P<0.001). Local reactions peaked at day 4, with a mean maximum composite score of 9.1 on the local-skin-response scale (which ranges from 0 to 4 for six types of reaction, yielding a composite score of 0 to 24, with higher numbers indicating more severe reactions), rapidly decreased by day 8, and continued to decrease, approaching baseline scores by day 29. In a pooled analysis of the two trials involving the trunk and extremities, the rate of complete clearance was also higher with ingenol mebutate than with placebo (34.1% vs. 4.7%, P<0.001). Local skin reactions peaked between days 3 and 8 and declined rapidly, approaching baseline by day 29, with a mean maximum score of 6.8. Adverse events were generally mild to moderate in intensity and resolved without sequelae.. Ingenol mebutate gel applied topically for 2 to 3 days is effective for field treatment of actinic keratoses. (Funded by LEO Pharma; ClinicalTrials.gov numbers, NCT00742391, NCT00916006, NCT00915551, and NCT00942604.).

Topics: Aged; Dermatologic Agents; Diterpenes; Extremities; Facial Dermatoses; Female; Humans; Keratosis, Actinic; Male; Middle Aged; Scalp Dermatoses; Skin; Thorax; Treatment Outcome

Actinic keratosis (AK) represents a risk of progression to squamous cell carcinoma. Ingenol mebutate gel is a novel therapeutic option for field-directed treatment.. To evaluate the safety, tolerability and patients' perspectives, related to the therapeutic success of managing AKs on the face and scalp with ingenol mebutate gel in Brazilian individuals.. This was an observational, retrospective and descriptive study of 68 areas of actinic keratosis on the face and scalp treated with Ingenol mebutate gel involving a total of 37 patients. The drug was applied for three consecutive days on an area of of 25 cm2 and documentation was performed on baseline and days 4, 8, 15, 60 and 180. On day 4, the composite local skin reaction score was calculated. At the end, a questionnaire was applied to evaluate patients' perspectives about the treatment.. Adherence was 100%, no serious adverse events were recorded and the mean composite local skin reaction score (standard deviation) was 8.61±4.22. The treatment was considered optimum by 75.68% of the patients.. Calculation of composite local skin reaction score performed only on the fourth day.. Treatment with ingenol mebutate gel was considered safe and tolerable in Brazilian subjects. Patients had a maximum adherence rate and a great improvement in self-esteem. The results of this research reproduce the findings of the literature.

Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Brazil; Dermatologic Agents; Diterpenes; Facial Dermatoses; Female; Gels; Humans; Keratosis, Actinic; Male; Middle Aged; Retrospective Studies; Scalp Dermatoses; Surveys and Questionnaires; Treatment Outcome

Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Body Surface Area; Diterpenes; Facial Dermatoses; Gels; Health Care Surveys; Humans; Keratosis, Actinic; Middle Aged; Nurse's Role; Patient Satisfaction

Ingenol mebutate (IngMeb) 0.015% gel is an approved field treatment option for non-hyperkeratotic non-hypertrophic actinic keratosis (AK) of face and scalp. Efficacy of IngMeb has been assessed only on a clinical ground, in the majority of studies. Dermoscopy is a pivotal tool for the diagnosis of AK, while its role in evaluating the response to non-surgical therapies for AK has not been fully defined.. Our study aims to determine whether some dermoscopic features of AK of the face and scalp areas may independently predict the response to IngMeb therapy.. Clinical and dermoscopic responses, 1 month after 0.015% IngMeb therapy, were retrospectively evaluated using a per-patient and per-lesion approach. Safety was evaluated through local skin reaction composite score calculation. Demographic, clinical and dermoscopic factors were then evaluated via univariate and multivariate logistic regression analysis to assess independent predictors of response.. Fifty-five patients with 245 AKs were enrolled. Clinically, per-patient response evaluation identified 25 (45.4%) poor/partial and 30 (54.5%) complete responders, corresponding on a per-lesion approach to 66 (26.9%) and 179 (73.1%) AKs, respectively. Dermoscopy reclassified 14 patients in the per-patient and 48 AKs in the per-lesion analysis from complete to poor/partial responders. Multivariate logistic regression analysis showed that AKs dermoscopically characterized by red pseudonetwork and located on the face were independently associated with a complete dermoscopic response to 0.015% IngMeb therapy, while microerosions were negative predictors.. Specific dermoscopic features of AK may predict the response to 0.015% IngMeb therapy, together with the location on the face.

Topics: Administration, Cutaneous; Aged; Aged, 80 and over; Antineoplastic Agents; Dermoscopy; Diterpenes; Erythema; Facial Dermatoses; Female; Gels; Humans; Keratosis, Actinic; Male; Predictive Value of Tests; Retrospective Studies; Scalp Dermatoses; Treatment Outcome

Actinic keratoses are cutaneous lesions that appear as the result of the proliferation of atypical keratinocytes. These lesions are considered pre-malignant and they can progress to squamous cell carcinoma. Ingenol mebutate has been approved as an effective treatment for AK on the face and trunk. We studied the local skin reactions to this therapy. Data about local skin reactions were collected in a series of 5 patients with photographic documentation, a visual analog scale, and a ranking of satisfaction of the patient. Moderate to severe reactions were reported in most of patients, but only one stopped treatment early. The short duration of treatment contributes to high adherence to the therapy.

Topics: Administration, Cutaneous; Antineoplastic Agents; Diterpenes; Drug Eruptions; Facial Dermatoses; Humans; Keratosis, Actinic; Scalp Dermatoses

Topics: Dermatologic Agents; Diterpenes; Facial Dermatoses; Gels; Humans; Keratosis, Actinic; Microscopy, Confocal; Middle Aged; Prospective Studies; Scalp Dermatoses

Ingenol mebutate gel, a topical field treatment for actinic keratosis (AK), elicits inflammatory application-site reactions in most patients. This analysis explored the relationship between the intensity of local skin reactions (LSRs) and AK clearance, measured by the reduction in AK count from baseline in 218 patients who were treated for AK on the face in the pivotal Phase 3 studies. The analysis modeled the AK count at week 8, adjusted for baseline count, with the composite LSR score at 1 day after the last treatment application for each patient as a predictor to estimate the mean and 90% prediction interval for the percent reduction in AK count. The predicted mean percent reduction in AK count was higher in patients with higher composite LSR scores. Lower composite scores demonstrated a variable, less predictive percentage reduction in efficacy. Therefore, a large inflammatory reaction from ingenol mebutate gives a more reliable prognosis for improved AK clearance.

J Drugs Dermatol. 2017;16(2):112-114.

Topics: Administration, Cutaneous; Clinical Trials, Phase III as Topic; Diterpenes; Double-Blind Method; Drug-Related Side Effects and Adverse Reactions; Facial Dermatoses; Gels; Humans; Keratosis, Actinic; Prognosis; Randomized Controlled Trials as Topic; Regression Analysis

Granuloma faciale (GF) is a rare chronic inflammatory dermatosis of unknown etiology, characterized by leukocitoclastic vasculitis usually occurring on the face. We report a case of 60-years-old man with 3 year history of multiple actinic keratoses (AK) and persistent asymptomatic erythematous papules and plaques located over his left temporal region and the cheek: histopathology was consistent with GF. Herein we describe the successful treatment of the lesion with ingenol mebutate 0.015% gel focusing on the clinical, dermoscopic and histopathological findings of GF both before and after treatment.

Topics: Administration, Cutaneous; Biopsy; Dermatologic Agents; Dermoscopy; Diterpenes; Facial Dermatoses; Gels; Granuloma; Humans; Keratosis, Actinic; Male; Middle Aged; Remission Induction; Skin; Treatment Outcome

Cryotherapy is the most common treatment for actinic keratosis, but its effect is limited to individual lesions. Several topical drugs, however, are available that, in addition to treating individual actinic keratoses, target field cancerization and thereby act on subclinical lesions. Examples are 5-fluorouracil, imiquimod, diclofenac, and ingenol mebutate. We report on 17 patients with actinic keratoses treated with ingenol mebutate and describe our findings on treatment effectiveness, adherence, and tolerance. Complete and partial response rates were 35% and 53%, respectively. Ninety-four percent of patients fully adhered to treatment and 18% developed severe local reactions. Ingenol mebutate is an effective treatment for actinic keratosis. Although it has a similar rate of local reactions to other treatments available for actinic keratosis, its short treatment regimen favors better adherence.

Topics: Aged; Aged, 80 and over; Combined Modality Therapy; Cryotherapy; Diterpenes; Drug Eruptions; Drug Evaluation; Facial Dermatoses; Female; Humans; Keratosis, Actinic; Male; Medication Adherence; Middle Aged; Remission Induction; Retrospective Studies; Scalp Dermatoses; Treatment Outcome

Actinic keratoses (AKs) are defined as cutaneous areas of atypical squamous transformation that are regarded as an early step in the continuum of alterations leading from normal skin to invasive and metastatic squamous cell carcinoma (SCC). AKs are classified as precancerous lesions by some authors and in situ SCC by others. The rate of evolution of a given AK to an invasive SCC has been estimated as 0·075-0·096% per lesion per year. These rates are similar to those estimated for gynaecological intraepithelial neoplasia. We describe two cases of SCC with rapid onset that developed after the application of ingenol mebutate gel for the treatment of AKs.

Topics: Aged; Aged, 80 and over; Carcinoma, Squamous Cell; Dermatologic Agents; Diterpenes; Drug Eruptions; Facial Dermatoses; Facial Neoplasms; Female; Head and Neck Neoplasms; Humans; Keratosis, Actinic; Skin Neoplasms