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A Double Blind Phase II Study Comparing Safety and Efficacy of Tacrolimus Versus Topical Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus.


Phase 2
2 Years
N/A
Open (Enrolling)
Female
Vulvar Lichen Sclerosus

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Trial Information

A Double Blind Phase II Study Comparing Safety and Efficacy of Tacrolimus Versus Topical Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus.


Inclusion Criteria:



- Female, 2 years or older

- Medical diagnosis of vulvar lichen sclerosus

- Received no treatment during the last 4 weeks

Exclusion Criteria:

- Who have received topical steroids, tacrolimus or pimecrolimus during the 4 last
weeks.

- Who are immunocompromised

- Who have history of intra-epithelial neoplasia or anogenital carcinoma

- Who have active vulvar infections (herpes,condylomas,vaginitis)

- Who are hypersensitive to tacrolimus, pimecrolimus or corticosteroids

- Who have physical limitations that cause difficulty in applying the cream

- Who wear diapers

- Who present Hyperkeratotic Vulvar Lichen Sclerosus

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Comparison before the treatment and monthly for 3 months.

Safety Issue:

No

Principal Investigator

Deana Funaro, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Justine's Hospital

Authority:

Canada: Health Canada

Study ID:

StJustineH

NCT ID:

NCT00757874

Start Date:

April 2006

Completion Date:

January 2010

Related Keywords:

  • Vulvar Lichen Sclerosus
  • Female urogenital disease
  • skin disease
  • Vulvar Lichen Sclerosus
  • Lichen Sclerosus et Atrophicus

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