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Proof of Concept Study to Investigate the Recurrence of Acne Post Isotretinoin

2014-08-27 03:20:47 | BioPortfolio

Summary

The use of topical retinoids is a mainstay and basis of early acne treatment to prevent the progression to inflammatory lesions. Post oral isotretinoin, it is not uncommon for non-inflammatory papules and comedones to recur. However, there has been no formal study to look at the prevention of recurrence of these acne lesions post isotretinoin in a long term basis. This may enhance the therapeutic options for post isotretinoin patients in order to prevent recurrence of their disease.

Hypothesis Tretinoin microsphere 0.04% will prevent recurrence of acne lesions.

Description

Subjects will be randomized 1:1 to study product or vehicle. Subjects will be randomly assigned to each group by an unblinded dispenser.

The study duration will be 24 weeks with visits at baseline (week 0), week 4, week 8, week 16 and week 24. All study products will be administered once daily for 24 weeks. Subjects will apply a sufficient amount of study product to cover the entire face.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Acne

Intervention

tretinoin microsphere 0.04% gel, vehicle gel

Location

Dermatrials Research
Hamilton
Ontario
Canada
L8N 1V6

Status

Active, not recruiting

Source

Dermatrials Research

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:20:47-0400

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