A double-blind, randomized controlled trial of clobetasol versus pimecrolimus in patients with vulvar lichen sclerosus.

BACKGROUND: Lichen sclerosus (LS) is a lymphocyte-mediated chronic cutaneous disorder with a predilection for the vulva. The current gold standard treatment is topical ultrapotent corticosteroids such as clobetasol. OBJECTIVE: We sought to compare the safety and efficacy of clobetasol and pimecrolimus in the treatment of vulvar LS. METHODS: This double-blind, randomized trial enrolled 38 women with biopsy-proven vulvar LS. This study consisted of a 2-week screening period and a 12-week treatment period. The primary efficacy variable was the change in inflammation, as determined by a dermatopathologist, on the biopsy specimens obtained at screening and at the week 12 visit. Secondary efficacy variables included the change from baseline in pruritus and burning/pain as assessed by patients using a visual analog scale and a clinical evaluation by the investigator. RESULTS: Clobetasol was found to be superior in improving inflammation when compared with pimecrolimus (P = .015). Both groups showed improvement in pruritus and burning/pain but this difference was not statistically significant (P = .32 and .93, respectively). Both clobetasol and pimecrolimus were found to be effective in decreasing both the total score on the Investigator Global Assessment (P = .001) and all 3 subscales. Serum levels of pimecrolimus and clobetasol did not approach levels of concern during the study period. No adverse events were reported. LIMITATIONS: This study was limited by the relatively short study duration. CONCLUSION: Both clobetasol and pimecrolimus appear efficacious and well tolerated for the treatment of vulvar LS; however, clobetasol is more effective than pimecrolimus and should remain first-line therapy for LS.

The treatment of vulvar lichen sclerosus and female sexual dysfunction.

INTRODUCTION: Women with lichen sclerosus (LS) are more likely to have dyspareunia, decreased orgasm, and decreased coital frequency as compared to unaffected women. It is unknown whether standard medical therapy to treat LS results in improved sexual functioning. AIMS: To describe sexual function in women with LS and to assess if LS-associated sexual dysfunction decreases after appropriate medical therapy. METHODS: Women enrolled in a double-blind trial 12-week trial comparing clobetasol vs. pimecrolimus for the treatment of LS were administered the Female Sexual Distress Scale (FSDS) upon enrollment and at the end of the trial. The difference in the total score on the FSDS between the two groups before and after treatment was assessed with a paired t-test. MAIN OUTCOME MEASURES: The change in mean FSDS score from baseline to 12 weeks. RESULTS: A total of 31 out of 36 enrolled women had adequate treatment of LS as determined by a dermatopathologist's evaluation of pre and post-treatment biopsy specimens. The mean baseline FSDS score for the clobetasol group was 29 and, post-treatment, it was 15 (P=0.001). In the pimecrolimus group, the mean baseline FSDS score was 27 and, post-treatment, it was 21 (P=0.001). CONCLUSIONS: Despite adequate treatment, women with LS continue to have significant sexual dysfunction as assessed by the FSDS.

UV-A and UV-B penetration of normal human cadaveric fingernail plate.

OBJECTIVE: To assess the extent to which UV-A and UV-B radiation can penetrate the human fingernail plate. DESIGN: The Dermalite UV light machine (National Biological, Beachwood, Ohio) was used as the source of UV radiation. The amount of UV-A and UV-B penetrating the nail plate was measured using a radiometer and compared with a control. SETTING: Academic phototherapy clinic. PATIENTS: Ten cadaver fingernails were obtained from 1 cadaver from the National Disease Research Interchange. Because the objective was to determine transmission through normal fingernails, grossly diseased or deformed nails were not used. MAIN OUTCOME MEASURES: The percentage of UV light penetration through each fingernail was calculated by dividing the amount of radiation measured when the fingernail was in front of the light by the amount of radiation measured when there was nothing in front of the light (UV with nail divided by UV without nail). RESULTS: All 10 fingernails completely blocked the UV-B light, reading 0 mW/cm(2) on the radiometer. The mean penetration of UV-A light through the fingernails was 1.65%, ranging from 0.56% for the right fifth digit to 2.43% for the left second digit. CONCLUSIONS: The nail plate completely blocked UV-B light, and only a minimal amount of UV-A light penetrated the nails. If UV is required to directly penetrate the nail to treat nail bed psoriasis, then these data suggest that therapeutic efficacy may be compromised by the intervening nail plate. This minimal penetration of UV-A light may explain why therapies such as psoralen-UV-A (PUVA) have low efficacy for the treatment of nail psoriasis.