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Excerpt
Thirty-two patients with biopsy-proven vulvar lichen sclerosus, after 24 weeks of treatment with 0.05 percent clobetasol propionate cream, were randomly distributed into two groups of 16 each and treated for an additional length of time (24 weeks) with 2 percent testosterone ointment or a cream-based preparation (placebo). The patients were examined before and after treatment for symptoms, gross aspects, and histologic features.
The 32 patients were then randomly distributed into two groups of 16. One group was treated with 2 percent topical testosterone propionate in a petrolatum vehicle-galenic preparation and the other one with a placebo, a cream-based preparation (petrolatum vehicle alone). Both testosterone and placebo were administered once a day for 24 weeks.
After clobetasol treatment, symptomatic relief was experienced by all the patients, with a reduction in the cumulative score for symptoms of 58 to 9 (P less than 0.001).
A similar improvement was observed for gross aspects, with a cumulative score reduction from 82 to 38 (P less than 0.001). Concerning the parameters for clinical evaluation, an evident reduction was found mainly in hyperkeratosis and sclerosis, although atrophy seemed to change very little. Some frequently associated features, such as erosion and purpura, totally disappeared.
Concerning histology, complete regression of changes was observed in 12 patients, whereas the remaining ones showed some improvement. Regarding histologic features, a marked improvement was observed in the inflammatory infiltrate, edema, and fibrosis. In no patients were signs of contact dermatitis and/or evidence of infection noted. Only mild, asymptomatic erythema was seen in three women at the end of therapy. Neither clinical nor histologic evidence of worsening of epidermal atrophy was observed.
Sixteen patients (randomized) applied 2 percent testosterone propionate as maintenance treatment for 16 weeks. During this period, four (25.0 percent) of these patients had burning upon application of the ointment, and nine (56.2 percent) complained of recurrence of symptoms, especially itching, mild in four and severe in five. Nevertheless, these patients were asked to continue the testosterone application. After treatment, the comparison between the score assigned before and after maintenance treatment showed a statistically significant worsening of symptoms (P less than 0.05).
Modifications in the severity score assigned to gross aspects did not seem statistically significant. No virilizing effects were noted.
In 16 placebo- or vehicle-treated patients, the cream was not only well tolerated, as expected, but was reported to have a soothing effect on vulvar skin. Three patients reported additional improvements in symptoms, although three complained of a recurrence of itching to a mild degree; the score change was not statistically significant. No changes in the gross aspects were noted.
A comparison of the clinical effects observed after testosterone and vehicle use showed a better response to vehicle for symptoms (P less than 0.01) and no difference for gross aspects.
(Over the past 5 years or so it has become increasingly evident that superpotent steroids are the most effective way to treat vulvar lichen sclerosus. In general, a 12-week course of topical 0.05 percent clobetasol propionate (Temovate, Glaxo Dermatology, Research Triangle Park, NC) applied twice daily, usually results in an 80 to 100 percent improvement in symptoms of itching, burning, etc., and an associated resolution of the clinical and histologic changes of hyperkeratosis, erosion and atrophy (Bracco et al., J Reprod Med 1993;38:37).
