A Clinical Study Evaluating the Safety and Efficacy of IDP-115 in Patients With Rosacea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT00667173
First received: April 23, 2008
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to assess the safety and effectiveness of IDP-115 in treating patients with rosacea.


Condition Intervention Phase
Rosacea
Drug: IDP-115
Drug: Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Dow Pharmaceutical Sciences:

Primary Outcome Measures:
  • Change from baseline in the number of inflammatory lesions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Improvement from baseline in global severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in erythema [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: November 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667173

Locations
United States, Alabama
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
Solano Clinical Research
Vallejo, California, United States, 94589
United States, Colorado
Cherry Creek Dermatology Research Inc.
Denver,, Colorado, United States, 80246
United States, Florida
FXM Research Corp.
Miami, Florida, United States, 33175
United States, Georgia
MedaPhase Inc.
Newnan, Georgia, United States, 30263
United States, Michigan
Henry Ford Medical Center
Detroit, Michigan, United States, 48202
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, Ohio
University Dermatology Consultants, Inc.
Cincinnati, Ohio, United States, 45219
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
Sponsors and Collaborators
Dow Pharmaceutical Sciences
  More Information

No publications provided

Responsible Party: Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier: NCT00667173     History of Changes
Other Study ID Numbers: DPSI-IDP-115-P2-01
Study First Received: April 23, 2008
Last Updated: February 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014