Back to resultsCombination Treatment for Moderate to Severe Acne
Primary Purpose
Acne
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide
Sponsored by
About this trial
This is an interventional treatment trial for Acne focused on measuring Acne
Eligibility Criteria
Inclusion Criteria:
- moderate to severe acne, IGA = 3 or 4 (Investigator Global Assessment)
Exclusion Criteria:
- pregnancy and allergies
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open Label Combination
Arm Description
Solodyn, Ziana, Triaz FC
Outcomes
Primary Outcome Measures
Proportion of patients showing improvement from Baseline and Week 12
Secondary Outcome Measures
Full Information
NCT ID
NCT01206348
First Posted
September 17, 2010
Last Updated
November 28, 2011
Sponsor
Medicis Global Service Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01206348
Brief Title
Combination Treatment for Moderate to Severe Acne
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medicis Global Service Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
A Phase IV, Open-Label Study Evaluating the treatment for Combination Acne Therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
Acne
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Label Combination
Arm Type
Experimental
Arm Description
Solodyn, Ziana, Triaz FC
Intervention Type
Drug
Intervention Name(s)
Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide
Intervention Description
Solodyn 1 tablet, Q day Ziana Gel, topical Q am Triaz FC, topical Q night
Primary Outcome Measure Information:
Title
Proportion of patients showing improvement from Baseline and Week 12
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
moderate to severe acne, IGA = 3 or 4 (Investigator Global Assessment)
Exclusion Criteria:
pregnancy and allergies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Sanstead, BSN, CCRP
Organizational Affiliation
Medicis Global Service Corporation
Official's Role
Study Chair
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Santa Monica
State/Province
California
Country
United States
City
Hockessin
State/Province
Delaware
Country
United States
City
Chestnut Hill
State/Province
Massachusetts
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Henderson
State/Province
Nevada
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Hershey
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Combination Treatment for Moderate to Severe Acne
We'll reach out to this number within 24 hrs