A Clinical Study Evaluating the Safety and Efficacy of IDP-115 in Patients With Rosacea
Sponsor
Dow Pharmaceutical Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT00667173
Collaborator
(none)
140
10
3
8
14
1.8
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety and effectiveness of IDP-115 in treating patients with rosacea.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multi-Center, Evaluator-Blind, Randomized, Vehicle-Controlled Clinical Study to Assess the Safety and Efficacy of IDP-115 in the Treatment of Rosacea
Study Start Date
:
Nov 1, 2007
Actual Primary Completion Date
:
Jul 1, 2008
Actual Study Completion Date
:
Jul 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: IDP-115
Topical application for 12 weeks
|
| Placebo Comparator: 2
|
Drug: Vehicle
Topical application for 12 weeks
|
| Placebo Comparator: 3
|
Drug: Vehicle
Topical application for 12 weeks
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in the number of inflammatory lesions [12 weeks]
- Improvement from baseline in global severity [12 weeks]
Secondary Outcome Measures
- Change from baseline in erythema [12 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Presence of facial rosacea
-
Presence of inflammatory lesions
Exclusion Criteria:
-
Dermatological conditions of the face that could interfere with clinical evaluations
-
Known history of photosensitivity disorders (such as lupus erythematosus or polymorphous light eruption)
-
Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical Affiliated Research Center, Inc. | Huntsville | Alabama | United States | 35801 |
| 2 | Therapeutics Clinical Research | San Diego | California | United States | 92123 |
| 3 | Solano Clinical Research | Vallejo | California | United States | 94589 |
| 4 | Cherry Creek Dermatology Research Inc. | Denver, | Colorado | United States | 80246 |
| 5 | FXM Research Corp. | Miami | Florida | United States | 33175 |
| 6 | MedaPhase Inc. | Newnan | Georgia | United States | 30263 |
| 7 | Henry Ford Medical Center | Detroit | Michigan | United States | 48202 |
| 8 | Academic Dermatology Associates | Albuquerque | New Mexico | United States | 87106 |
| 9 | University Dermatology Consultants, Inc. | Cincinnati | Ohio | United States | 45219 |
| 10 | DermResearch, Inc. | Austin | Texas | United States | 78759 |
Sponsors and Collaborators
- Dow Pharmaceutical Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT00667173
Other Study ID Numbers:
- DPSI-IDP-115-P2-01
First Posted:
Apr 25, 2008
Last Update Posted:
Feb 20, 2012
Last Verified:
Feb 1, 2012
Additional relevant MeSH terms: