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

This study has been terminated.
(Too much difficulty recruiting and retaining patients, PI decided to stop.)
Sponsor:
Collaborator:
Stiefel, a GSK Company
Information provided by (Responsible Party):
David Richard THOMAS, Derm Research @ 888 Inc.
ClinicalTrials.gov Identifier:
NCT00240513
First received: October 16, 2005
Last updated: February 22, 2012
Last verified: February 2012
  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 plus tretinoin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
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:


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

Primary Outcome Measures:
  • Long-term efficacy [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse rate [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: August 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Minocycline 3 mo
Minocycline 3 mo
Drug: Minocycline
100 mg capsules OD for 3 months
Other Name: Minocin
Experimental: Minocycline plus Tretinoin
Minocycline plus Tretinoin for 3 months
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, British Columbia
Derm Research @ 888 Inc
Vancouver, British Columbia, Canada, V5Z 3Y1
Sponsors and Collaborators
Derm Research @ 888 Inc.
Stiefel, a GSK Company
Investigators
Principal Investigator: Richard Thomas, MD, FRCP(C) DermResearch @ 888 Inc.
  More Information

No publications provided

Responsible Party: David Richard THOMAS, MD FRCP(C), Derm Research @ 888 Inc.
ClinicalTrials.gov Identifier: NCT00240513     History of Changes
Other Study ID Numbers: 2004-03
Study First Received: October 16, 2005
Last Updated: February 22, 2012
Health Authority: Canada: Health Canada

Keywords provided by Derm Research @ 888 Inc.:
Acne

Additional relevant MeSH terms:
Tretinoin
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on September 18, 2014