Stuart D. Shanler

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.

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 Physicians 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 Physicians 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.

Irregular Erythematous Nodule on the Upper Arm—Quiz Case

An 11-month-old Hispanic boy was seen for evaluation of severe pruritus. At 4 months of age, he began developing pruritic papules on his trunk and scalp, which often blistered and were noted to be aggravated by heat. Desloratadine, diphenhydramine hydrochloride, topical retapamulin, and topical hydrocortisone butyrate had been prescribed with minimal improvement. His review of systems was remarkable for nearly constant pruritus and chronic, intermittent diarrhea. Physical examination revealed an alert and healthy infant. On his trunk were urticarial papules and plaques, and new lesions could be induced with pressure (Figure 1 and Figure 2). Subtle thickening of his skin was felt over portions of his trunk and proximal extremities. He had no hepatosplenomegaly or lymphadenopathy. A complete blood cell count showed 506 000 μL (506 10/L) platelets, with 6.0% monocytes, 5.1% eosinophils, and 1.7% basophils. An incisional biopsy sample was obtained and sent for histopathologic examination (Figure 3). What is your diagnosis?

Solitary nodule on the thigh

Andrew L. Ondo, MD; Stuart D. Shanler, MD; Jesse Y. Howell; Robert E. Cashman, MD; Clay J. Cockerell, MD; University of New Mexico School of Medicine, Albuquerque, and Las Cruces Dermatology Associates, Las Cruces, New Mexico (Dr Ondo); New Mexico State University, Las Cruces (Mr Howell); and University of Texas Southwestern Medical Center, Dallas (Drs Cashman and Cockerell); Dr Shanler is in private practice in New York, New York