Study to Compare the Acne Relapse Rate of Oral Minocycline to Oral Minocycline in Combination With Topical Tretinoin, Followed by Topical Tretinoin Alone
Information source: Derm Research @ 888 Inc.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: Minocycline (Drug); Minocycline + Tretinoin 0.01% (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Derm Research @ 888 Inc. Official(s) and/or principal investigator(s):
Richard Thomas, MD, FRCP(C), Principal Investigator, Affiliation: DermResearch @ 888 Inc.
Overall contact:
Frances Maddin, MA, Phone: 604-873-4049, Email: trials@dermatologyresearch.com
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: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
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
Frances Maddin, MA, Phone: 604-873-4049, Email: trials@dermatologyresearch.com
DermResearch @ 888 Inc, Vancouver, British Columbia V5Z 3Y1, Canada; Recruiting
Richard Thomas, MD, FRCP(C), Principal Investigator
Charles Morton, MD FRCP(C), Sub-Investigator
Additional Information
Starting date: August 2004
Ending date: December 2006
Last updated: January 31, 2006
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