Conditions: Prevention of Hair Growth
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: yes

Brief summary:
This is a two-arm, single center placebo-controlled double-blind proof of concept study which will evaluate the safety and efficacy of topical cidofovir (both 1% and 3%)compared to placebo for the prevention of hair growth.

Detailed description:
This is a phase II randomized, placebo controlled double blind, dose-ranging clinical trial of topical cidofovir for the prevention of hair growth. This proof of concept study will evaluate 1% and 3% cidofovir in petrolatum topically applied once a day to the target treatment area on the hair bearing area of the face known as the beard area. This target area will be of a circular shape with a diameter of three centimeters along the jaw line of one side of the face.The first 14 enrolled subjects in the study will be randomized in a 1:1 fashion to receive either 1% topical cidofovir and placebo or 3% topical cidofovir and placebo. The last cohort of subjects to be enrolled in the study to achieve a total of 16 evaluable subjects will all receive the 3% formulation and placebo. Subjects will also be randomized as to which side of their face (left or right) will receive active drug versus placebo.

Subjects will be treated for up to eight weeks. Any subject who achieves 100% alopecia (which corresponds to a 0 on the PGA of Hair Density) in the treated area prior to eight weeks will be classified as a responder and will discontinue active treatment and begin the four week observation period. From the time of discontinuing treatment, subjects will be followed for four weeks during which time safety data will be collected.

Arms:
arm 1: 1% topical cidofovir to one side of the face and placebo to the other side of the face arm 2: 3% topical cidofovir to one side of the face and placebo to the other side of the face

Interventions: intervention 1: 1% topical cidofovir intervention 2: 3% topical cidofovir intervention 3: Placebo
Intervention descriptions: intervention 1: 1% topical cidofovir intervention 2: 3% topical cidofovir intervention 3: topical placebo

Protocol document: