Study design.
skin redness, skin injury
ADVERSE REACTIONS, SKIN REDNESS
The study was composed of a total of 14 visits over 8 weeks (Chemical skin injury was induced using the vesicating agent, NM, as a model. Topical NM in the form of FDA-approved Valchlor (mechlorethamine) 0.016% gel was applied under Finn chamber occlusion to 3 adjacent 8 mm areas of each participant’s inner brachial arm. Occlusion chambers, which were used to standardize the topical NM exposures among patients, were removed after 48 hours. The dose of NM applied to each participant (approximately 0.033 g/application) is 200,000 times less than the total amount applied during an average MF-CTCL treatment. It was selected to induce a low-grade chemical injury without significant adverse reactions. Repeat measurements of skin redness and thickness were performed 48, 72, 96, and 168 hours after NM application. Photos of the exposed sites were taken at each visit. At the 72-hour visit, an 8 mm punch biopsy was performed from one of the mechlorethamine sites and processed for histologic evaluation.Two weeks after the initial NM application, an identical procedure was used to apply NM gel under occlusion to the previously unexposed arm of each participant. After application, participants in the control group received 4 oral placebo tablets. Those in the intervention group received 200,000 IU of 25(OH)D