Treatment of Cutaneous Squamous Cell Carcinoma In Situ With Curettage Followed by Topical Imiquimod 5% Cream.

BACKGROUND: Treatment strategies for cutaneous squamous cell carcinoma in situ (cSCCIS) are many but reported cure rates are variable and few studies report 5-year follow-up data. OBJECTIVE: To evaluate the treatment of cSCCIS by curettage followed by topical imiquimod 5% cream (C&I). METHODS: We evaluated all immunocompetent patients with biopsy proven cSCCIS treated by C&I between January 2008 and December 2012. RESULTS: A total of 861 patients with 1,198 cSCCIS were treated, with median follow-up of 71 months. The mean tumor diameter was 10.2 mm. The average duration of treatment with imiquimod 5% cream was 21 days. Kaplan-Meier estimated recurrence-free survival at 5-year follow-up was 99.71% with 95% CI (99.38%, 100.00%). A follow-up questionnaire returned by 45% of patients revealed that 94% were satisfied with their treatment. Six hundred eleven patients developed a new nonmelanoma skin cancer (NMSC) during the follow-up period, and 91% (556/611) of patients chose this combination treatment for at least one new NMSC. CONCLUSION: The combination treatment for cSCCIS of C&I had less than 1% cumulative probability of treatment failure at 5 years. Patients tolerated the treatment well, with the majority choosing this method of treatment for at least one new NMSC.

Oxymetazoline and Energy-Based Therapy in Patients with Rosacea: Evaluation of the Safety and Tolerability in an Open-Label, Interventional Study.

BACKGROUND AND OBJECTIVES: The objectives of this study were to evaluate the safety, tolerability, and efficacy of oxymetazoline hydrochloride cream, 1% (oxymetazoline) when used as an adjunctive treatment with energy-based therapy for patients with moderate to severe facial erythema associated with rosacea. STUDY DESIGN/MATERIALS AND METHODS: In this Phase 4, multicenter, interventional, open-label study, eligible patients received one of four energy-based therapies (potassium titanyl phosphate laser, intense pulsed light therapy, pulsed-dye laser Vbeam Perfecta, or pulsed-dye laser Cynergy) on day 1 and day 29 and once-daily application of oxymetazoline on days 3 through 27 and days 31 through 56. Improvement from baseline in Clinician Erythema Assessment (CEA) score, patient satisfaction measures, incidence of treatment-emergent adverse events (TEAEs), and worsening from baseline on dermal tolerability assessments and the Clinician Telangiectasia Assessment (CTA) were assessed. Data were summarized using descriptive statistics. RESULTS: A total of 46 patients (mean age, 51.1 years; 78.3% female) enrolled in this study. Similar numbers of patients received each of the energy-based therapies in addition to oxymetazoline. All patients demonstrated an improvement from baseline in CEA during the study with 39 of 43 evaluable patients (90.7%) demonstrating an improvement 6 hours posttreatment on day 56. Most patients were satisfied or very satisfied with treatment at the end of the study. All TEAEs were mild or moderate in severity. Some patients experienced worsening in dermal tolerability assessment symptoms (range: 4-21 patients; 8.7-45.7%). Worsening in CEA and CTA were each reported by three patients (6.5%) at any time during the study. CONCLUSIONS: Treatment with oxymetazoline as adjunctive therapy with energy-based therapy was safe, well tolerated, and reduced facial erythema in patients with moderate to severe persistent facial erythema associated with rosacea. Lasers Surg. Med. © 2020 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.

Assessing Patients' Satisfaction With Hydrogen Peroxide Topical Solution, 40% for Treatment of Raised Seborrheic Keratoses.

OBJECTIVES: Assess participants’ satisfaction following treatment with a proprietary hydrogen peroxide topical solution 40%, w/w (HP40) for raised seborrheic keratoses (SKs). METHODS: In this Phase 4, open-label study, eligible participants aged 30–75 years had clinically typical raised SKs including 2 target SKs (Physician’s Lesion Assessment™ [PLA] grade of ≥2 [0 = clear; 1 = near clear; 2 = thin (≤1 mm); 3 = thick (>1 mm)]; 5–15 mm diameter) on the face and 1 target SK on the neck or décolletage. SKs received HP40 treatment on day 1. All SKs with PLA grade ≥1 were retreated on days 15 and 29. Endpoints included patients’ satisfaction with their skin’s appearance at day 113, relationships between patients’ satisfaction and lesion PLA grade (evaluated by chi-square test), and patients’ satisfaction with their treatment experience. RESULTS: Forty-one patients (mean [range] age, 62.4 [46–73] years) completed the study. 95% of patients were at least moderately satisfied with their skin’s appearance and 90.2% of target lesions were clear. A statistically significant association was observed between the number of target lesions achieving clearance and patients’ satisfaction with skin appearance level (χ2=22.03; P=0.001). 93% of patients were at least moderately satisfied with their HP40 treatment experience. Eight patients experienced treatment-emergent adverse events (TEAEs), most of which were mild or moderate; 4 experienced TEAEs considered treatment-related. CONCLUSIONS: Most patients with SKs on the face, neck, and décolletage were satisfied or very satisfied with both their skin’s appearance and their treatment experience following HP40 treatment. These results support the use of HP40 for raised SKs. J Drugs Dermatol. 2020;19(12): doi:10.36849/JDD.2020.4974.

Anatomic Site-Specific Treatment Response With 40% Hydrogen Peroxide (w/w) Topical Formulation for Raised Seborrheic Keratoses: Pooled Analysis of Data from Two Phase 3 Studies.

OBJECTIVE: Seborrheic keratoses (SKs) may present in any non-glabrous skin, but data are limited on the response to treatment as based on the SK location. We aimed to understand the relationship between SK location and clearance with up to 2 treatments of 40% (w/w) hydrogen peroxide topical solution (HP40). METHODS: We conducted a sub-analysis of data pooled from two randomized, double-blind, vehicle (VEH)-controlled clinical trials, including 937 patients, each with 4 target SKs (N=3,748 SKs), with at least 1 on the face and 1 on the trunk or extremities. Treatment response was defined as 0 or 1 on a 4-point Physician's Lesion Assessment (PLA) scale (0=clear; 1=near-clear) after up to 2 applications, 3 weeks apart, and was assessed by SK location (face, trunk, and extremity). Local skin reactions were stratified by anatomic location and categorized based on immediate and delayed post-treatment reactions. Sensitivity analysis was conducted using the mean-per-patient (MPP) percent of SKs that are clear or near-clear at day 106. RESULTS: Treatment response was greater with HP40 versus VEH regardless of anatomic location of the SK. Clear or near-clear SKs with HP40 was observed in 65% of facial SKs (vs 10% VEH), 46% of truncal SKs (vs 5% VEH), and 38% of extremity SKs (vs 9% VEH). Facial SKs were more likely to be clear or near clear after a single treatment (43%), versus SKs on the trunk (31%) or extremities (14%). Most common immediate reactions with HP40 were erythema, stinging, and edema, which resolved to none or mostly mild within a week. Delayed reactions such as dyspigmentation and scarring occurred at low rates and were least reported for the facial SKs. CONCLUSIONS: SK clearance with HP40 was highest among SKs on the face and lowest among SKs on the extremities. Dyspigmentation rates were lowest among SKs treated on the face. Anatomic location of SK was a predictor of both treatment response and risk of dyspigmentation with HP40 application. ClinicalTrials.gov listings: NCT02667236 and NCT02667275 J Drugs Dermatol. 2018;17(10):1092-1098.

Safety and efficacy of hydrogen peroxide topical solution, 40% (w/w), in patients with seborrheic keratoses: Results from 2 identical, randomized, double-blind, placebo-controlled, phase 3 studies (A-101-SEBK-301/302).

BACKGROUND: Approved topical treatments for seborrheic keratoses (SKs) are an unmet need. OBJECTIVE: To evaluate the safety and efficacy of 40% hydrogen peroxide topical solution (HP40) versus vehicle for the treatment of SKs (A-101-SEBK). METHODS: A total of 937 patients with 4 SKs each (≥1 lesion each on the face and on the trunk and/or an extremity) were randomized 1:1 to HP40 or vehicle. At each visit, SKs were graded using the Physician's Lesion Assessment (PLA) scale (0, clear; 1, nearly clear; 2, ≤1 mm thick; and 3, >1 mm thick). After 1 treatment, SKs with a PLA score higher than 0 were re-treated 3 weeks later. RESULTS: At day 106, significantly more patients treated with HP40 than with vehicle achieved a PLA score of 0 on all 4 SKs (study 1, 4% vs 0%; study 2, 8% vs 0% [both P < .01]) and on 3 of 4 SKs (study 1, 13% vs 0%; study 2, 23% vs 0% [both P < .0001]). A higher mean per-patient percentage of SKs were clear (study 1, 25% vs 2%; study 2, 34% vs 1%) and clear or nearly clear (study 1, 47% vs 10%; study 2, 54% vs 5%) with HP40 than with vehicle. Local skin reactions were largely mild and resolved by day 106. LIMITATIONS: The optimal number of treatment sessions was not evaluated. CONCLUSION: Application of HP40 was well tolerated and effective in the removal of SKs.

A-101, a Proprietary Topical Formulation of High-Concentration Hydrogen Peroxide Solution: A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Dose-Response Profile in Subjects With Seborrheic Keratosis of the Face.

BACKGROUND: Seborrheic keratosis (SK) is a common benign skin tumor, yet no topical treatments are approved in the United States. OBJECTIVE: To evaluate the proprietary, stabilized, high-concentration hydrogen peroxide-based topical solution A-101 (32.5% and 40% concentrations) for treatment of facial SK lesions. MATERIALS AND METHODS: In this multicenter, double-blind, vehicle-controlled study, eligible subjects were randomly assigned to receive up to 2 treatments of A-101 40%, A-101 32.5%, or vehicle solution applied to a single facial SK lesion. The primary efficacy assessment was the Physician's Lesion Assessment (PLA), a validated 4-ordinal scale. RESULTS: The primary end point, the mean reduction in PLA grade from baseline to Day 106 was 1.7 for A-101 40%, 1.4 for A-101 32.5%, and 0.1 for vehicle (p < .001, both concentrations vs vehicle). Lesions for 68%, 62%, and 5% of subjects, respectively, were judged to be clear or near clear (p < .001, both concentrations vs vehicle). Local skin reactions were predominantly mild and transient. No subjects discontinued because of treatment-related adverse events. CONCLUSION: A-101 solution demonstrated efficacy in treating SKs on the face. Greater magnitude of effect was seen with the 40% concentration than the 32.5% concentration. A-101 solution had a favorable safety and tolerability profile at both concentrations.

Treatment-refractory actinic keratoses successfully treated using simultaneous combination topical 5-fluorouracil cream and imiquimod cream: a case-control study.

BACKGROUND: Most actinic keratoses (AKs) respond to standard treatments, but a subset persist and require further intervention. We report a series of 10 patients with AKs that failed to respond to conventional treatment with cryotherapy and topical monotherapy but responded completely to simultaneous therapy with topical 5-fluorouracil (5-FU) and imiquimod creams. OBJECTIVE: To report the success of this combination therapy in refractory AKs and to determine whether any clinical or histologic features predict for treatment resistance. METHODS: Case-control study with two control groups matched to each patient according to lesion location and sex. RESULTS: Mean lesion diameter (p < .001), lesion diameter greater than 1 cm (p < .001), and the presence of pain (p = .01) were statistically associated with failure of cryotherapy and topical monotherapy. None of the histologic features evaluated were found to be statistically significant, although thicker epidermis was nearly so (p = .054). CONCLUSIONS: In patients who have failed standard therapy for AKs, combination treatment using topical 5-FU and imiquimod cream may be an effective alternative therapeutic strategy. Larger lesion diameter, specifically greater than 1 cm, and the presence of pain predict conventional treatment resistance.

Cutaneous leishmaniasis with boggy induration and simultaneous mucosal disease.

A woman had cutaneous, mucosal, and possible visceral leishmaniasis simultaneously. Many of her cutaneous lesions consisted of boggy indurations rather than customary papules, nodules, or ulcers. This unusual case was finally cured after four courses of miltefosine, one course of antimony, and two courses of Ambisome.

Topical combination therapy for cutaneous squamous cell carcinoma in situ with 5-fluorouracil cream and imiquimod cream in patients who have failed topical monotherapy.

Topical therapeutic options for cutaneous squamous cell carcinoma in situ include 5-fluorouracil cream and imiquimod cream. Such treatment may be preferable to surgical or destructive modalities in certain anatomic locations and in instances where patients are unwilling or poor surgical candidates. We present 4 such patients with cutaneous squamous cell carcinoma in situ involving a digit. Each patient failed treatment with imiquimod cream as monotherapy. In addition, two patients failed treatment with 5-fluorouracil cream as monotherapy. All 4 responded completely to 5-fluorouracil and imiquimod cream as combination therapy. In patients who have failed monotherapy with a topical agent for cutaneous squamous cell carcinoma in situ, combination treatment using both topical 5-fluorouracil cream and imiquimod cream may be considered as an alternative therapeutic strategy.