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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00240513
Recruitment Status : Terminated (Too much difficulty recruiting and retaining patients, PI decided to stop.)
First Posted : October 18, 2005
Last Update Posted : February 24, 2012
Sponsor:
Collaborator:
Stiefel, a GSK Company
Information provided by (Responsible Party):
David Richard THOMAS, Derm Research @ 888 Inc.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Minocycline Drug: Minocycline plus tretinoin Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : August 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Long-term efficacy [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Relapse rate [ Time Frame: 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240513


Locations
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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
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Principal Investigator: Richard Thomas, MD, FRCP(C) DermResearch @ 888 Inc.
More Information
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Responsible Party: David Richard THOMAS, MD FRCP(C), Derm Research @ 888 Inc.
ClinicalTrials.gov Identifier: NCT00240513    
Other Study ID Numbers: 2004-03
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: February 24, 2012
Last Verified: February 2012
Keywords provided by David Richard THOMAS, Derm Research @ 888 Inc.:
Acne
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Minocycline
Tretinoin
 Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents