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Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema of 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: NCT01789775
Recruitment Status : Completed
First Posted : February 12, 2013
Results First Posted : October 20, 2014
Last Update Posted : October 20, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea

Condition or disease Intervention/treatment Phase
Rosacea Drug: Drug: CD07805/47 gel Drug: CD07805/47 gel Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2012
Primary Completion Date : October 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: CD07805/47 gel Placebo
Placebo
Drug: Drug: CD07805/47 gel
Experimental: CD07805/47 gel
Intervention: Drug: CD07805/47 gel
Drug: CD07805/47 gel Placebo


Outcome Measures

Primary Outcome Measures :
  1. Composite Success Assessment (CEA) and Patient Self Assessment(PSA). [ Time Frame: Day 29 ]
    Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).


Secondary Outcome Measures :
  1. Composite Success Assessment (CEA) and Patient Self Assessment(PSA). [ Time Frame: D1 ]
    30 Minutes Effect is defined as 1 grade improvement on CEA and PSA at 30 minutes.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Male or female who is at least 18 years of age or older.
  2. A clinical diagnosis of facial rosacea.
  3. A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).
  4. A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).

Key Exclusion Criteria:

  1. More than 20 facial inflammatory lesions of rosacea
  2. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
  3. Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists.
  4. Less than 3 months stable dose treatment with tricyclic anti depressants, cardiac glycosides, beta blockers or other antihypertensive agents.
  5. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
Contacts and Locations

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): NCT01789775


Locations
France
Galderma Investigational Site
Montpellier, France, 34
Galderma Investigational Site
Nice, France, 06
Russian Federation
Galderma Investigational Site
Chelyabinsk, Russian Federation
Galderma Investigational Site
Ekaterinburg, Russian Federation
Galderma Investigational Site
Moscow, Russian Federation
Galderma Investigational Site
Saint-Petersburg, Russian Federation
Sweden
Galderma Investigational Site
Eskilstuna, Sweden
Sponsors and Collaborators
Galderma R&D
More Information

Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01789775     History of Changes
Other Study ID Numbers: RD.03.SPR.40174
First Posted: February 12, 2013    Key Record Dates
Results First Posted: October 20, 2014
Last Update Posted: October 20, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Rosacea
Skin Diseases