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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.


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.


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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