Study to Compare the Acne Relapse Rate of Oral Minocycline to Oral Minocycline in Combination With Topical Tretinoin, Followed by Topical Tretinoin Alone

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2005 by Derm Research @ 888 Inc.. Recruitment status was Recruiting

First Received on October 16, 2005. Last Updated on January 31, 2006 History of Changes

Sponsor:	Derm Research @ 888 Inc.
Collaborators:	Investigator initiated study Stiefel, a GSK Company
Information provided by:	Derm Research @ 888 Inc.
ClinicalTrials.gov Identifier:	NCT00240513

Purpose

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.

Condition	Intervention	Phase
Acne Vulgaris	Drug: Minocycline Drug: Minocycline + Tretinoin 0.01%	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Minocycline Minocycline hydrochloride Tretinoin

U.S. FDA Resources

Further study details as provided by Derm Research @ 888 Inc.:

Primary Outcome Measures:

Long-term efficacy

Secondary Outcome Measures:

Relapse rate

Estimated Enrollment:	50
Study Start Date:	August 2004
Estimated Study Completion Date:	December 2006

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240513

Contacts

Contact: Frances Maddin, MA	604-873-4049	trials@dermatologyresearch.com
Contact: Selena Roy, RN	604-873-4049	selena@acne.ca

Locations

Canada, British Columbia
DermResearch @ 888 Inc	Recruiting
Vancouver, British Columbia, Canada, V5Z 3Y1
Principal Investigator: Richard Thomas, MD, FRCP(C)
Sub-Investigator: Charles Morton, MD FRCP(C)

Sponsors and Collaborators

Derm Research @ 888 Inc.

Investigator initiated study

Stiefel, a GSK Company

Investigators

Principal Investigator:

Richard Thomas, MD, FRCP(C)

DermResearch @ 888 Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00240513 History of Changes
Other Study ID Numbers:	2004-03
Study First Received:	October 16, 2005
Last Updated:	January 31, 2006
Health Authority:	Canada: Health Canada

Keywords provided by Derm Research @ 888 Inc.:

Acne

Additional relevant MeSH terms:

Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Minocycline
Tretinoin

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 12, 2012