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

NCT ID: NCT00240513

Last Updated: 2012-02-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2006-12-31

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Minocycline 3 mo

Minocycline 3 mo

Group Type: ACTIVE_COMPARATOR

Minocycline

Intervention Type: DRUG

100 mg capsules OD for 3 months

Minocycline plus Tretinoin

Minocycline plus Tretinoin for 3 months

Group Type: EXPERIMENTAL

Minocycline plus tretinoin

Intervention Type: DRUG

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

Interventions

Minocycline

100 mg capsules OD for 3 months

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Minocin; Minocin; 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stiefel, a GSK Company

INDUSTRY

Sponsor Role: collaborator

Derm Research @ 888 Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

David Richard THOMAS

MD FRCP(C)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Thomas, MD, FRCP(C)

Role: PRINCIPAL_INVESTIGATOR

DermResearch @ 888 Inc.

Locations

Derm Research @ 888 Inc

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

2004-03

Identifier Type: -

Identifier Source: org_study_id