Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema of Rosacea
This study is currently recruiting participants.
Verified April 2013 by Galderma R&D
Sponsor:
Galderma R&D
Information provided by (Responsible Party):
Galderma R&D
ClinicalTrials.gov Identifier:
NCT01789775
First received: February 8, 2013
Last updated: April 12, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Estimated Enrollment: | 110 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 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:
- Male or female who is at least 18 years of age or older.
- A clinical diagnosis of facial rosacea.
- 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).
- 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:
- More than 20 facial inflammatory lesions of rosacea
- 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.
- Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists.
- Less than 3 months stable dose treatment with tricyclic anti depressants, cardiac glycosides, beta blockers or other antihypertensive agents.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789775
Contacts
| Contact: Sandrine TEISSEDRE, MBsc | 33 4 92 95 29 95 | sandrine.teissedre@galderma.com |
| Contact: Jean Charles DHUIN, MBsc | 33 4 92 95 29 21 | jean-charles.dhuin@galderma.com |
Locations
| Russian Federation | |
| Galderma Investigational Site | Recruiting |
| Chelyabinsk, Russian Federation | |
| Contact: Galderma Investigational Site | |
| Galderma Investigational Site | Recruiting |
| Ekaterinburg, Russian Federation | |
| Contact: Galderma Investigational Site | |
| Galderma Investigational Site | Recruiting |
| Moscow, Russian Federation | |
| Contact: Galderma Investigational Site | |
| Galderma Investigational Site | Suspended |
| Saint-Petersburg, Russian Federation | |
| Galderma Investigational Site | Active, not recruiting |
| Saratov, Russian Federation | |
| Sweden | |
| Galderma Investigational Site | Recruiting |
| Eskilstuna, Sweden | |
| Contact: Galderma Investigational Site | |
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: | SPR40174 |
| Study First Received: | February 8, 2013 |
| Last Updated: | April 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 May 19, 2013