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

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

Sponsors

Lead Sponsor: Derm Research @ 888 Inc.

Collaborator: Stiefel, a GSK Company

Source Derm Research @ 888 Inc.
Brief Summary

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

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.

Overall Status Terminated
Start Date August 2004
Completion Date December 2006
Primary Completion Date December 2006
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Long-term efficacy 4 years
Secondary Outcome
Measure Time Frame
Relapse rate 4 years
Enrollment 38
Condition
Intervention

Intervention Type: Drug

Intervention Name: Minocycline

Description: 100 mg capsules OD for 3 months

Arm Group Label: Minocycline 3 mo

Other Name: Minocin

Intervention Type: Drug

Intervention Name: Minocycline plus tretinoin

Description: 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

Arm Group Label: Minocycline plus Tretinoin

Eligibility

Criteria:

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.

Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Richard Thomas, MD, FRCP(C) Principal Investigator DermResearch @ 888 Inc.
Location
Facility: Derm Research @ 888 Inc
Location Countries

Canada

Verification Date

February 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Derm Research @ 888 Inc.

Investigator Full Name: David Richard THOMAS

Investigator Title: MD FRCP(C)

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Minocycline 3 mo

Type: Active Comparator

Description: Minocycline 3 mo

Label: Minocycline plus Tretinoin

Type: Experimental

Description: Minocycline plus Tretinoin for 3 months

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov