Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00989014
Recruitment Status : Completed
First Posted : October 2, 2009
Results First Posted : November 21, 2013
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.

Condition or disease Intervention/treatment Phase
Erythematotelangiectatic Rosacea Drug: CD07805/47 Drug: CD07805/47 placebo Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Dose-Finding Study Investigating the Pharmacodynamics and Safety of Three Concentrations of CD07805/47 Topical Gel (0.07%, 0.18%, and 0.50%), Applied in Subjects With Moderate to Severe Erythematotelangiectatic Rosacea
Study Start Date : September 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: CD07805/47 0.5% Topical Gel
0.5% Topical Gel
 Drug: CD07805/47
0.5% Topical Gel
Experimental: CD07805/47 0.18% Topical Gel
0.18% Topical Gel
 Drug: CD07805/47
0.18% Topical Gel
Experimental: CD07805/47 0.07% Topical Gel
0.07% Topical Gel
 Drug: CD07805/47
0.07% Topical Gel
Placebo Comparator: CD07805/47 Vehicle Topical Gel
Vehicle Topical Gel
 Drug: CD07805/47 placebo
Vehicle Topical Gel


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing. [ Time Frame: Baseline and every hour for 12 hours following application ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female who is at least 18 years of age.
  • Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea.
  • CEA (clinician's erythema assessment) score greater than or equal to 3 at Screening and on Treatment visit at baseline.
  • PSA (patient self assessment) score of greater than or equal to 3 at Screening and on Treatment visit at baseline.
  • Presence of 2 or fewer inflammatory facial lesions.

Exclusion Criteria:

  • History of Raynaud's Syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression.
  • History of refractive surgery such as photorefractive keratectomy.
  • The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants.
  • The subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the Treatment visit.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00989014


Locations
Layout table for location information
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, Pennsylvania
Philadephia Institute of Dermatology
Fort Washington, Pennsylvania, United States, 19034
United States, Texas
Derm Research, Inc
Austin, Texas, United States, 78759
J&S Studies
College Station, Texas, United States, 77845
United States, Virginia
The Education & Research Foundation
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Galderma R&D
Investigators
Layout table for investigator information
Study Director: Michael Graeber, MD Galderma R&D
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT00989014    
Other Study ID Numbers: RD.06.SPR.18144
First Posted: October 2, 2009    Key Record Dates
Results First Posted: November 21, 2013
Last Update Posted: February 18, 2021
Last Verified: September 2013
Keywords provided by Galderma R&D:
Erythematotelangiectatic
Rosacea
Additional relevant MeSH terms:
Layout table for MeSH terms
Rosacea
Skin Diseases