Proof of Concept Study to Investigate the Recurrence of Acne Post Isotretinoin
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||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|
- Primary objectives-to assess the efficacy of Retin A micro 0.04% on the recurrence rate of acne post isotretinoin use compared to vehicle. [ Time Frame: Six Months ] [ Designated as safety issue: No ]
- The percent change in lesion counts from baseline to week 16 and 24. [ Time Frame: Six Months ] [ Designated as safety issue: No ]
- Proportion of subjects who have a Subject's Global [ Time Frame: Assessment score of 0 or 1 at week 16 and 24 ] [ Designated as safety issue: No ]
- Proportion of subjects who have an ISGA score of 0 or 1 at week 16 and 24. [ Time Frame: At week 16 and 24 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: Tretinoin microsphere 0.04% gel||
Drug: tretinoin microsphere 0.04% gel
Applied daily to entire face for six months
Other Name: Retin A micro 0.04%
|Placebo Comparator: Vehicle gel||
Drug: vehicle gel
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939133
|Hamilton, Ontario, Canada, L8N 1V6|
|Principal Investigator:||Ronald Vender, MD FRCPC||Dermatrials Research|