NCT00939133

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

Double Blinded Vehicle Controlled Proof of Concept Study to Investigate the Recurrence of Inflammatory and Non-inflammatory Acne Lesions Using Tretinoin Gel (Microsphere) 0.04% in Male Patients Post Oral Isotretinoin Use

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Dermatrials Research · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	tretinoin microsphere 0.04% gel	Applied daily to entire face for six months
DRUG	vehicle gel	Placebo

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-07-14
• Last updated: 2015-02-10

Locations

1 site across 1 country: Canada