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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00240513
• Other study ID #: 2004-03
• Status: Terminated
• Phase: Phase 4
• First received: October 16, 2005
• Last updated: February 22, 2012
• Start date: August 2004
• Est. completion date: December 2006

Study information

• Verified date: February 2012
• Source: Derm Research @ 888 Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Minocycline
100 mg capsules OD for 3 months
• 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

Locations

Country	Name	City	State
Canada	Derm Research @ 888 Inc	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Derm Research @ 888 Inc.	Stiefel, a GSK Company

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term efficacy		4 years	No
Secondary	Relapse rate		4 years	No