Condition(s) treated: Acne Vulgaris

Intervention: Minocycline (Drug); Minocycline + Tretinoin 0.01% (Drug)

Phase: Phase 4

Enrollment status: Recruiting

Sponsor: Derm Research @ 888 Inc.

Principal investigator(s) or official(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

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.

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.

Eligible 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.

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

Start date: August 2004
End date: December 2006
Last updated: January 31, 2006

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