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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
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.
Details
| Lead sponsor | Dermatrials Research |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 20 |
| Start date | 2009-07 |
| Completion | 2010-12 |
Conditions
- Acne
Interventions
- tretinoin microsphere 0.04% gel
- vehicle gel
Primary outcomes
- Primary objectives-to assess the efficacy of Retin A micro 0.04% on the recurrence rate of acne post isotretinoin use compared to vehicle. — Six Months
Countries
Canada