Study Stopped
Too much difficulty recruiting and retaining patients, PI decided to stop.
Study Comparing Acne in Patients Taking Oral Minocycline to Patients Taking Minocycline Plus Topical Tretinoin
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
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2004
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 16, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFebruary 24, 2012
February 1, 2012
2.3 years
October 16, 2005
February 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-term efficacy
4 years
Secondary Outcomes (1)
Relapse rate
4 years
Study Arms (2)
Minocycline 3 mo
ACTIVE COMPARATORMinocycline 3 mo
Minocycline plus Tretinoin
EXPERIMENTALMinocycline plus Tretinoin for 3 months
Interventions
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
Eligibility Criteria
You may qualify if:
- Provision of written consent
- Either sex
- Any age
- Diagnosis of acne vulgaris with a minimum of 20 inflammatory acne lesions on the face.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Derm Research @ 888 Inc.lead
- Stiefel, a GSK Companycollaborator
Study Sites (1)
Derm Research @ 888 Inc
Vancouver, British Columbia, V5Z 3Y1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Thomas, MD, FRCP(C)
DermResearch @ 888 Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD FRCP(C)
Study Record Dates
First Submitted
October 16, 2005
First Posted
October 18, 2005
Study Start
August 1, 2004
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
February 24, 2012
Record last verified: 2012-02