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

Sponsor
Derm Research @ 888 Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00240513
Collaborator
Stiefel, a GSK Company (Industry)
38
Enrollment
1
Location
2
Arms
28
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
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 :
Aug 1, 2004
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
Dec 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Minocycline 3 mo

Minocycline 3 mo

Drug: Minocycline
100 mg capsules OD for 3 months
Other Names:
  • 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
    Other Names:
  • Minocin
  • Tretinoin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Long-term efficacy [4 years]

    Secondary Outcome Measures

    1. Relapse rate [4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Derm Research @ 888 Inc Vancouver British Columbia Canada V5Z 3Y1

    Sponsors and Collaborators

    • Derm Research @ 888 Inc.
    • Stiefel, a GSK Company

    Investigators

    • Principal Investigator: Richard Thomas, MD, FRCP(C), DermResearch @ 888 Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Richard THOMAS, MD FRCP(C), Derm Research @ 888 Inc.
    ClinicalTrials.gov Identifier:
    NCT00240513
    Other Study ID Numbers:
    • 2004-03
    First Posted:
    Oct 18, 2005
    Last Update Posted:
    Feb 24, 2012
    Last Verified:
    Feb 1, 2012
    Keywords provided by David Richard THOMAS, MD FRCP(C), Derm Research @ 888 Inc.
    Acne
    Additional relevant MeSH terms:
    Acne Vulgaris
    Minocycline
    Tretinoin

    Study Results

    No Results Posted as of Feb 24, 2012