Comparative, placebo controlled, double-blind efficacy and safety study in patients with seborrhoeic dermatitis comparing a topical cream containing 2% Nicotinamide combined with either 0%, 0.5% or 1.0% GMCY with the placebo cream.
- Conditions
- Seborrhoeic Dermatitis.
- Registration Number
- EUCTR2006-005637-37-GB
- Lead Sponsor
- Astion Danmark A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
The following criteria have to be met for inclusion of a patient in the study:
• Patients of either sex aged 18 to 70
• A clinical diagnosis of facial seborrhoeic dermatitis defined as inflamed dermatitis with erythema, scaling involving the medial part of the eyebrows, and/or the glabella, and/or the nasolabial folds,
• A baseline overall severity score >3 (sum of the erythema score and the scaling score)
• A score for erythema >2
• Phototype: I to IV
• Signed informed consent
• Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide.
• Willing and able to comply to the study procedures
• Prepared to grant authorized persons access to the medical records
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) yes
F.1.3.1 Number of subjects for this age range
Patients will not be included in the study when one or more of the following conditions are met:
• Female patient who is pregnant or breast-feeding
• Known allergy to one of the constituents of the product being tested
• Presence of a serious or progressive disease which, according to the investigator may interfere with treatment outcome
• Active skin disease in the face other than seborrhoeic dermatitis
• Patient receiving systemic medical treatment:
• Anti-inflammatory and/or antihistamine and/or antibiotics and/or anti-fungal during the week preceding the pre-inclusion day
• Immunosuppressant, corticoids during the 4 weeks preceding the pre-inclusion day
• Retinoids during the 6 months preceding the pre-inclusion day
• Excessive exposure to the sun or to U.V
• Patient planning to change his/her hygiene habits and toilet products during the study.
• Patient using dermopharmaceutical or cosmetic product other than the studied products on face over the period of the study.
• Patient who is taking part in another clinical trial or has taken part in one during the last month preceding the inclusion day (D0).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method