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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00240513

Enrollment

Registered

2005-10-18

Start date

2004-08-31

Completion date

2006-12-31

Last updated

2012-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

Acne

Brief 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.

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.

Interventions

DRUGMinocycline

100 mg capsules OD for 3 months

DRUGMinocycline 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Long-term efficacy	4 years

Secondary

Measure	Time frame
Relapse rate	4 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026