CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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Testosterone maintenance therapy. Effects on vulvar lichen sclerosus treated with clobetasol propionate.

OBJECTIVE: To evaluate the possible effects of topical testosterone as maintenance therapy after clobetasol propionate treatment.

STUDY DESIGN: Thirty-two patients with biopsy-proven vulvar lichen sclerosus (LS), after 24 weeks of treatment with 0.05% clobetasol propionate cream, were randomly distributed into two groups of 16 each and treated for a further length of time (24 weeks) with testosterone 2% ointment or a cream-based preparation (placebo). The patients were examined before and after treatment for symptoms, gross aspects and histologic features.

RESULTS: With clobetasol propionate all patients had a marked improvement (P < .001) in both clinical and histologic parameters. After clobetasol propionate therapy, the 16 testosterone-treated patients had significant worsening of their symptoms (P < .05%) and no evident changes in gross aspects (P = NS). The placebo-treated group had good symptomatic control of their disease, with no significant changes in symptoms or gross aspects (P = NS).

CONCLUSION: After the good results obtained with clobetasol propionate, treatment with testosterone appeared to have a negative effect, while a regularly provided emollient cream was useful in symptom control.

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