Seborrhoeic Dermatitis.
Conditions
Interventions
Product Name: ASF-1057 cream glycerylmonocaprylate 1.0% + nictotinamide 2%
Pharmaceutical Form: Cream
INN or Proposed INN: glycerylmonocaprylate
Concentration unit: % (W/W) percent weight/weight
Conce
Sponsors
Astion Danmark A/S
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria
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 • 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the treatment effect obtained with ASF-1057 Cream GMCY 0% + Nicotinamide 2% or ASF-1057 Cream GMCY 0.5% + Nicotinamide 2% or ASF-1057 Cream GMCY 1.0% + Nicotinamide 2% to each others and versus ASF-1057 Cream Placebo with respect to number of responders, defined as patients obtaining absence of symptoms (overall severity score (OSS) =1) at the last visit (D21). ;Secondary Objective: To compare the treatment effect obtained with ASF-1057 Cream GMCY 0% + Nicotinamide 2% or ASF-1057 Cream GMCY 0.5% + Nicotinamide 2% or ASF-1057 Cream GMCY 1.0% + Nicotinamide 2% to each others and versus placebo cream with regard to the response/rating on/of: •Absence/clearance of symptoms •Erythema •Scaling •Pruritus •Global status •Quality of Life (QOL) •Recurrence rate of symptoms To assess and compare the safety profile of the active treatment groups with the placebo group. ;Primary end point(s): The primary efficacy variable of the study is the number of treatment responders, defined as patients obtaining absence of symptoms (overall severity score =1) | — |
Countries
United Kingdom
Outcome results
None listed