EUCTR2006-005637-37-GB
Active, not recruiting
Not Applicable
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.
Astion Danmark A/S0 sitesDecember 7, 2006
ConditionsSeborrhoeic Dermatitis.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Seborrhoeic Dermatitis.
- Sponsor
- Astion Danmark A/S
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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