Trial | NCT00240513  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    38
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.
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 Started
Aug 31
2004
Primary Completion
Dec 31
2006
Study Completion
Dec 31
2006
Last Update
Feb 24
2012
Estimate

Drug Minocycline

100 mg capsules OD for 3 months

  • Other names: Minocin

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

Minocycline 3 mo Active Comparator

Minocycline 3 mo

Minocycline plus Tretinoin Experimental

Minocycline plus Tretinoin for 3 months

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.
No Results Posted