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

Rosacea Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789775
• Other study ID #: RD.03.SPR.40174
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2013
• Last updated: October 14, 2014
• Start date: December 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2014
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review BoardRussia: Pharmacological Committee, Ministry of HealthRussia: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• Drug: CD07805/47 gel

• CD07805/47 gel Placebo

Locations

Country	Name	City	State
France	Galderma Investigational Site	Montpellier
France	Galderma Investigational Site	Nice
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
Sweden	Galderma Investigational Site	Eskilstuna

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

France,  Russian Federation,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Success Assessment (CEA) and Patient Self Assessment(PSA).	Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).	Day 29	No
Secondary	Composite Success Assessment (CEA) and Patient Self Assessment(PSA).	30 Minutes Effect is defined as 1 grade improvement on CEA and PSA at 30 minutes.	D1	No