Proof of Concept Study to Investigate the Recurrence of Acne Post Isotretinoin
|ClinicalTrials.gov Identifier: NCT00939133|
Recruitment Status : Completed
First Posted : July 14, 2009
Last Update Posted : February 10, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Acne||Drug: tretinoin microsphere 0.04% gel Drug: vehicle gel||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
|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
- 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 ]
- The percent change in lesion counts from baseline to week 16 and 24. [ Time Frame: Six Months ]
- Proportion of subjects who have a Subject's Global [ Time Frame: Assessment score of 0 or 1 at week 16 and 24 ]
- Proportion of subjects who have an ISGA score of 0 or 1 at week 16 and 24. [ Time Frame: At week 16 and 24 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939133
|Hamilton, Ontario, Canada, L8N 1V6|
|Principal Investigator:||Ronald Vender, MD FRCPC||Dermatrials Research|