Study Comparing Acne in Patients Taking Oral Minocycline to Patients Taking Minocycline Plus Topical Tretinoin
Information source: Derm Research @ 888 Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: Minocycline (Drug); Minocycline plus tretinoin (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Derm Research @ 888 Inc. Official(s) and/or principal investigator(s): Richard Thomas, MD, FRCP(C), Principal Investigator, Affiliation: DermResearch @ 888 Inc.
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Long-term efficacy
Secondary outcome: Relapse rate
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Derm Research @ 888 Inc, Vancouver, British Columbia V5Z 3Y1, Canada
Additional Information
Starting date: August 2004
Last updated: February 22, 2012
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