Combination Treatment for Moderate to Severe Acne
Sponsor
Medicis Global Service Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01206348
Collaborator
(none)
97
10
1
10
9.7
1
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
A Phase IV, Open-Label Study Evaluating the treatment for Combination Acne Therapy.
Study Design
Study Type:
Interventional
Actual Enrollment
:
97 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date
:
Sep 1, 2010
Actual Primary Completion Date
:
Jul 1, 2011
Actual Study Completion Date
:
Jul 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Open Label Combination Solodyn, Ziana, Triaz FC |
Drug: Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide
Solodyn 1 tablet, Q day Ziana Gel, topical Q am Triaz FC, topical Q night
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients showing improvement from Baseline and Week 12 [Week 12]
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- moderate to severe acne, IGA = 3 or 4 (Investigator Global Assessment)
Exclusion Criteria:
- pregnancy and allergies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | ||
| 2 | Santa Monica | California | United States | ||
| 3 | Hockessin | Delaware | United States | ||
| 4 | Chestnut Hill | Massachusetts | United States | ||
| 5 | Detroit | Michigan | United States | ||
| 6 | Henderson | Nevada | United States | ||
| 7 | High Point | North Carolina | United States | ||
| 8 | Hershey | Pennsylvania | United States | ||
| 9 | Nashville | Tennessee | United States | ||
| 10 | Salt Lake City | Utah | United States |
Sponsors and Collaborators
- Medicis Global Service Corporation
Investigators
- Study Chair: Mary Sanstead, BSN, CCRP, Medicis Global Service Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT01206348
Other Study ID Numbers:
- MP-0104-28
First Posted:
Sep 21, 2010
Last Update Posted:
Nov 30, 2011
Last Verified:
Nov 1, 2011
Keywords provided by Medicis Global Service Corporation
Additional relevant MeSH terms: