Study Comparing Acne in Patients Taking Oral Minocycline to Patients Taking Minocycline Plus Topical Tretinoin
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|ClinicalTrials.gov Identifier: NCT00240513|
Recruitment Status : Terminated (Too much difficulty recruiting and retaining patients, PI decided to stop.)
First Posted : October 18, 2005
Last Update Posted : February 24, 2012
The use of oral antibiotics alone to treat inflammatory acne provides little to no long term therapeutic benefit.
Acne relapse rates can be reduced by using topical tretinoin 0.01% in conjunction with minocycline, thereby increasing the therapeutic effect of the oral antibiotic.
|Condition or disease||Intervention/treatment||Phase|
|Acne Vulgaris||Drug: Minocycline Drug: Minocycline plus tretinoin||Phase 4|
Although oral antibiotics have been the mainstay of treatment of inflammatory acne for 30 years, studies comparing their efficacy have little scientific value.
Evidence-based dermatology proves minocycline to be an effective treatment for acne vulgaris while the patient remains on the medication; however, the relapse rate of acne after a course of antibiotics has never been established.
The relapse rate would appear to be significant, as repeated courses and long-term antibiotic use are commonly prescribed in practice. The increasing problem of drug resistance has raised issues of the suitability of such long term antibiotic treatment and this overuse is probably a contributing factor of multiple drug resistance in our society.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Study to Compare the Acne Relapse Rate After a 3-mo Course of Oral Minocycline, to a 3-mo Course of Oral Minocycline in Combination With a Daily Dose of Topical Tretinoin 0.01% Followed by 3 mo of Topical Tretinoin Alone|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
Active Comparator: Minocycline 3 mo
Minocycline 3 mo
100 mg capsules OD for 3 months
Other Name: Minocin
Experimental: Minocycline plus Tretinoin
Minocycline plus Tretinoin for 3 months
Drug: Minocycline plus tretinoin
100mg OD Minocycline for 12 weeks plus OD Topical tretinoin 0.01% for 12 weeks Followed by topical tretinoin 0.01% OD for 12 weeks alone
- Long-term efficacy [ Time Frame: 4 years ]
- Relapse rate [ Time Frame: 4 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240513
|Canada, British Columbia|
|Derm Research @ 888 Inc|
|Vancouver, British Columbia, Canada, V5Z 3Y1|
|Principal Investigator:||Richard Thomas, MD, FRCP(C)||DermResearch @ 888 Inc.|