Background
Actinic Keratosis is an intraepidermal neoplasm that represents the second most common reason for dermatologic visits in the United States. Sustained clearance with existing therapies is highly variable.
Objective
To assess the effects of combination and monotherapy with photodynamic therapy (PDT), grenz ray therapy, and PDT with microneedling (microchannel skin system) for actinic damage of the dorsal forearms and hands.
Methods
Full ethics approval was obtained through a Human Subjects Committee. Four patients with diffuse actinic field damage on their forearms and hands were recruited for the study. The dorsal forearm and hand from the elbow to the metacarpophalangeal joint were divided into four equal sections. Section 1 was treated with PDT. Section 2 was treated with grenz ray. Section 3 was treated with PDT plus microneedling. Section 4 was treated with grenz ray and PDT with microneedling. Lesion counts were recorded with transparent grids, photographed and evaluated by the same investigator at baseline, 1, 2, 3 and 6 months.
Results
At month 6 post treatment, lesion counts, as a per cent reduction from baseline, were 91.7% in section 1 (PDT); 97.3% in section 2 (grenz ray); 92.9% in section 3 (PDT + microneedle); and 93.9% in section 4 (grenz ray + PDT + microneedle).
Conclusion
The greatest reduction occurred in the grenz ray monotherapy section and the second greatest reduction in the grenz ray, PDT, microneedling section. Further research on the efficacy of grenz ray therapy for field treatment of actinic keratosis of the forearms and hands is needed.
Background: FMX101 4% is a novel FDA-approved minocycline-containing topical foam for the treatment for acne vulgaris. Objective: Compare the efficacy of FMX101 4% vs vehicle foam for acne based on the integrated analysis of 3 Phase 3 studies. Methods: In 3 multicenter, randomized, double-blind, Phase 3 studies (FX2014-04, N¼466; FX2014-05, N¼495; FX2017-22, N¼1488), FMX101 4% was compared to vehicle in subjects with moderate-tosevere acne. Subjects applied the study drug once daily for 12 weeks. The co-primary efficacy endpoints were the absolute change from baseline at week 12 in inflammatory lesions and the proportion of subjects with Investigator Global Assessment (IGA) treatment success. Percent change from baseline at week 12 in noninflammatory lesions was a secondary endpoint. Results: The integrated population included 2449 subjects (FMX101 4%, n¼1378; vehicle, n¼1071). FMX101 4% demonstrated statistically significant benefit vs vehicle for both coprimary endpoints. There was a significantly greater reduction in inflammatory lesions from baseline at week 12 in the FMX101 4% group compared to vehicle (P<.0001), and a significantly greater percent of FMX101 4% subjects who achieved IGA treatment success at week 12 compared to vehicle (P<.0001). The effect of FMX101 4% was observed as early as week 3, and was maintained throughout the 12-week trial. There was a significantly (P¼.0019) greater percent reduction in noninflammatory lesions at week 12 in the FMX101 4% group vs vehicle. Conclusions: FMX101 4% demonstrated statistically significant benefits compared to vehicle in treating moderate-to-severe acne vulgaris in the pooled population of 3 Phase 3 studies.
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