Activity of twice daily per os administration of CD06713 at 8mg versus its placebo during 4 weeks treatment, in patients with erythemato-telangiectatic rosacea.

• Conditions: Erythemato-Telangiectatic Rosacea (ETR); MedDRA version: 8.1Level: LLTClassification code 10039218Term: Rosacea

• Registration Number: EUCTR2006-003707-40-DE
• Lead Sponsor: Galderma Research and Development SNC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1 The subject is a male or female adult aged 18 to 65.

2 Subject with moderate to severe ETR characterized by:

2.1 A persistent erythema

2.2 An erythema severity score graded at least 2 on a 5-point scale, on each cheek

2.3 No history of inflammatory (papules and/or pustules) lesions during the past 3 months before inclusion

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1 The subject has a particular form of rosacea (papulopustular rosacea, rhinophyma, severe forms (rosacea conglobata or fulminans), corticosteroids-induced rosacea or isolated pustulosis of the chin), with facial erythrosis of any type (known carcinoid syndrome, dysthyroidism, mastocytosis, serotonin syndrome…) or with peri-oral dermatitis.

2 The subject has an underlying disease, surgical or medical condition, which:

2.1 could interfere with evaluations of the rosacea condition itself (e.g. lupus erythematosis, atopic dermatitis, eczema, acne vulgaris, and psoriasis)

2.2 could put the subject at risk (uncontrolled chronic or serious diseases which would normally prevent participation in any clinical trial, such as a cancer, AIDS, renal or hepatic impairment…)

3 The subject has a facial skin condition which would interfere with study assessments:

3.1 an abnormal pigmentation or skin type IV, V and VI on the Fitzpatrick scale

3.2 a beard or other facial hair

4. The subject has an abnormal ECG.

5. The subject has a past migraine history.

6. The subject is using an antimotility drug (i.e. loperamide).

7. The subject has a past digestive surgical history.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified