Study Comparing Acne in Patients Taking Oral Minocycline to Patients Taking Minocycline Plus Topical Tretinoin

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Minocycline
* Drug: Minocycline plus tretinoin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of written consent Either sex Any age Diagnosis of acne vulgaris with a minimum of 20 inflammatory acne lesions on the face. Exclusion Criteria: Known hypersensitivity to tetracyclines Use of any oral antibiotics in the previous 3 months Pregnancy, breast-feeding or lactating Inability or unwillingness to comply with the requirements of the protocol, or agree to the use of their data as determined by the investigator. Concomitant medical condition which, in the investigator's opinion, may confound the study results or interfere with study assessments or outcomes. Patients with severe acne on the chest, back or trunk.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Minocycline 3 mo<br>Minocycline 3 mo | Drug: Minocycline<br>* 100 mg capsules OD for 3 months<br>* Other names: Minocin;|
| Experimental: Minocycline plus Tretinoin<br>Minocycline plus Tretinoin for 3 months | Drug: Minocycline plus tretinoin<br>* 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<br>* Other names: Tretinoin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term efficacy |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse rate |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne