A Phase 2 interventional study of Tacrolimus cream and Clobetasol cream in Vulvar Lichen Sclerosus, sponsored by Deana Funaro. Completed at 1 site in Canada. Open to female participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2015-09-09.
Sponsored by Deana Funaro · Phase 2, Interventional, and Treatment
Lichen Sclerosus is an inflammatory skin condition affecting mostly the genital area of persons of all ages, gender or race. The most frequent complaint is that of itchiness of the vulva but pain may also occur. Some women will experience no symptoms at all. However, it is important to treat this condition since it may increase and cause important scarring and deformity. In less than 5% of cases, cancer may develop.
Lichen Sclerosus is a chronic disease which can be controlled but not cured. Topical corticosteroids are the usual treatment for this condition. Though this treatment is generally well tolerated, some patients may not present a sufficient response or may develop mainly local and rarely systemic side effects. In this perspective, an alternative treatment would be beneficial.
Tacrolimus, a topical immunomodulator has been approved for the treatment of atopic eczema and has shown its efficacy in the treatment of vulvar lichen sclerosus in a limited number of patients. Tacrolimus acts as a non-steroidal anti-inflammatory agent (NSAI) without causing the usual side effects seen with the prolonged use of topical corticosteroids.
This study is designed to evaluate the safety and efficacy of tacrolimus in treating vulvar lichen sclerosus by comparing it with the standard topical corticosteroid treatment.
36 studies on the registry are indexed under Vulvar Lichen Sclerosus; 10 are open to participants now.
This study's enrollment of 56 is above the median of 38 across 33 interventional studies indexed under Vulvar Lichen Sclerosus.
Browse Vulvar Lichen Sclerosus studies →This is the only study on the registry with Deana Funaro as lead sponsor.
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Exclusion Criteria:
Drug: Tacrolimus cream
Drug: Clobetasol cream
0.5 g per day at bed time for 3 months or less.
Also known as: Prtopic
0.5 gram each day at bed time during 3 months or less.
Also known as: Dermovate
To document the efficacy of Tacrolimus vs topical clobetasol propionate in the treatment of Vulvar Lichen Sclerosus by medical examinations and reporting of the symptoms. Cream is applied once a day for 3 months
Time frame: Comparison before the treatment and monthly for 3 months.
Compared presence and severity of side effects of both groups.
Time frame: During the 3 months of treatment
CBC, Glycemia, vitamine B 12 dosage, TSH (to find associated auto-immune diseases)
Time frame: At 1 to 3 months after starting the study, collected once.
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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