Combination Treatment for Moderate to Severe Acne
A Phase IV, Open-Label Study Evaluating the Use of Solodyn (Minocycline HCL Extended-Release Tablets), Ziana, and Triaz Foaming Cloths as Combination Acne Therapy Prior to Treatment With Isotretinoin
1 other identifier
interventional
97
1 country
10
Brief Summary
To determine if a combination of three currently approved acne products are safe and effective for the treatment of moderate to severe acne
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2010
Shorter than P25 for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 17, 2010
CompletedFirst Posted
Study publicly available on registry
September 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedNovember 30, 2011
November 1, 2011
10 months
September 17, 2010
November 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients showing improvement from Baseline and Week 12
Week 12
Study Arms (1)
Open Label Combination
EXPERIMENTALSolodyn, Ziana, Triaz FC
Interventions
Solodyn 1 tablet, Q day Ziana Gel, topical Q am Triaz FC, topical Q night
Eligibility Criteria
You may qualify if:
- moderate to severe acne, IGA = 3 or 4 (Investigator Global Assessment)
You may not qualify if:
- pregnancy and allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Santa Monica, California, United States
Unknown Facility
Hockessin, Delaware, United States
Unknown Facility
Chestnut Hill, Massachusetts, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Henderson, Nevada, United States
Unknown Facility
High Point, North Carolina, United States
Unknown Facility
Hershey, Pennsylvania, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Salt Lake City, Utah, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mary Sanstead, BSN, CCRP
Medicis Global Service Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2010
First Posted
September 21, 2010
Study Start
September 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
November 30, 2011
Record last verified: 2011-11