Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema of Rosacea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma R&D
ClinicalTrials.gov Identifier:
NCT01789775
First received: February 8, 2013
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Rosacea
Drug: Drug: CD07805/47 gel
Drug: CD07805/47 gel Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Galderma R&D:

Primary Outcome Measures:
  • Composite Success Assessment (CEA) and Patient Self Assessment(PSA). [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).


Secondary Outcome Measures:
  • Composite Success Assessment (CEA) and Patient Self Assessment(PSA). [ Time Frame: D1 ] [ Designated as safety issue: No ]
    30 Minutes Effect is defined as 1 grade improvement on CEA and PSA at 30 minutes.


Enrollment: 114
Study Start Date: December 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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
Sponsors and Collaborators
Galderma R&D
  More Information

No publications provided

Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01789775     History of Changes
Other Study ID Numbers: RD.03.SPR.40174
Study First Received: February 8, 2013
Last Updated: November 12, 2013
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Russia: Pharmacological Committee, Ministry of Health
Russia: Ethics Committee

Additional relevant MeSH terms:
Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014