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

Primary Purpose

Acne Vulgaris

Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Minocycline
Minocycline plus tretinoin
Sponsored by
Derm Research @ 888 Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Derm Research @ 888 Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Minocycline 3 mo

Minocycline plus Tretinoin

Arm Description

Minocycline 3 mo

Minocycline plus Tretinoin for 3 months

Outcomes

Primary Outcome Measures

Long-term efficacy

Secondary Outcome Measures

Relapse rate

Full Information

First Posted
October 16, 2005
Last Updated
February 22, 2012
Sponsor
Derm Research @ 888 Inc.
Collaborators
Stiefel, a GSK Company
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1. Study Identification

Unique Protocol Identification Number
NCT00240513
Brief Title
Study Comparing Acne in Patients Taking Oral Minocycline to Patients Taking Minocycline Plus Topical Tretinoin
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 Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Why Stopped
Too much difficulty recruiting and retaining patients, PI decided to stop.
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Derm Research @ 888 Inc.
Collaborators
Stiefel, a GSK Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minocycline 3 mo
Arm Type
Active Comparator
Arm Description
Minocycline 3 mo
Arm Title
Minocycline plus Tretinoin
Arm Type
Experimental
Arm Description
Minocycline plus Tretinoin for 3 months
Intervention Type
Drug
Intervention Name(s)
Minocycline
Other Intervention Name(s)
Minocin
Intervention Description
100 mg capsules OD for 3 months
Intervention Type
Drug
Intervention Name(s)
Minocycline plus tretinoin
Other Intervention Name(s)
Minocin, Tretinoin
Intervention Description
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
Primary Outcome Measure Information:
Title
Long-term efficacy
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Relapse rate
Time Frame
4 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Thomas, MD, FRCP(C)
Organizational Affiliation
DermResearch @ 888 Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Derm Research @ 888 Inc
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3Y1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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