Seborrhoeic dermatitis.
Conditions
Interventions
Product Name: ASF-1057 Cream 0.5%
Pharmaceutical Form: Cream
INN or Proposed INN: glycerylmonocaprylate
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number
Sponsors
Astion Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be entered into this trial only if they meet all of the following criteria: 1. Patients of either sex at least 18 years of age, 2. A clinical diagnosis of seborrhoeic dermatitis defined as inflamed dermatitis with both erythema and scaling, involving at least the medial part of the eyebrows, and/or the glabella, and/or the nasolabial folds, 3. Moderate to severe seborrhoeic dermatitis defined as an involvement of at least 4 cm2 skin area with an OSS = 4 score units and a score for erythema = 2 score units: Note: The degree of erythema and scaling at inclusion should be predominating throughout the area to be evaluated. It is not sufficient that there is only a small spot in the area with e.g., an erythema score = 2 score units for the patient to be included. 4. Skin type: I to IV, 5. Signed and dated informed consent, 6. Sexually active females of childbearing potential must be either surgically sterile (hysterectomy or tubal ligation) or use a medically accepted contraceptive method (and agree to use it during the trial) such as: Systemic contraceptive (oral, implant, injection), Diaphragm or cervical cap with intravaginal spermicide, Intrauterine device, or Condom with intravaginal spermicide. In Denmark and Germany, one of these contraceptive regimens must have been used for at least 12 weeks before Visit 2, and the patients must agree to continue their contraception during the trial and for 1 month after the end of the trial. 7. Willingness and ability to comply with the trial procedures. 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 enrolled if they meet any of the following criteria: 1. Female patients who are pregnant or breast-feeding, 2. Known allergy to any of the constituents of the product being tested, 3. Known immunosuppressive (e.g., AIDS/HIV) or neurological diseases (e.g., Parkinson’s disease or MS), 4. Presence of another serious or progressive disease which, according to the Investigator may interfere with treatment outcome, 5. Active skin disease such as psoriasis, atopic dermatitis, rosacea, lupus erythematosus, or other inflammatory or infectious skin disease which, according to the Investigator may interfere with treatment outcome, 6. Use of topical medical treatment in the face, e.g., anti inflammatory (e.g., corticosteroids, non-steroidal anti inflammatory drugs [NSAIDs] or calcineurine inhibitors), coal tar preparations, anti-seborrhoeic preparations, antihistamine, antibiotics, or antifungal during the 2 weeks preceding the baseline visit (Day 0), 7. Use of systemic medical treatment: a. Anti-inflammatory drugs (e.g., calcineurine inhibitors), antihistamines, antibiotics, antifungals during the 2 weeks before the baseline visit (Day 0), b. Corticosteroids and immunosuppressant treatment during the 4 weeks preceding the baseline visit (Day 0), c. Retinoids during the 6 months preceding the baseline visit (Day 0), 8. Planned change in hygiene habits and toilet products in the face during the trial, 9. Planned extensive sun exposure during trial participation (i.e., sun exposure leading to reddening of the skin), 10. Planned use of cosmetic products on the area to be treated such as; moisturizer, cleanser, facemasks, peeling creams and acne-stick or any other stick used to mask pimples during treatment period, 11. Participation in another clinical trial during the last month preceding the baseline visit (Day 0).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to show a superior treatment effect of ASF 1057 cream 0.5% over vehicle and/or placebo on moderate to severe seborrhoeic dermatitis in adult patients following 3 weeks twice daily treatment regimen in terms of responder rate (overall severity score [OSS] = 1 score units).;Secondary Objective: The secondary objectives are to compare and describe the efficacy and safety of ASF 1057 cream 0.5%, vehicle and placebo with regards to: • OSS, • Erythema, • Scaling, • Investigator global assessment (IGA) of disease status, • Pruritus, • Patient global assessment of disease status, • Safety and local tolerance profile. ;Primary end point(s): Percentages of responders (patients with OSS = 1 score units) at Visit 5 will be tabulated by treatment group. Two-sided 95% CIs for these proportions will be calculated by Wilson’s method. 2 sided 95% CIs for the pair-wise differences of the proportions (ASF 1057 minus vehicle, ASF-1057 minus placebo and placebo minus vehicle) will be computed by Newcombe’s method. ASF-1057 will be compared to the control treatments using a hierarchical testing scheme: In step 1, ASF-1057 will be statistically significantly superior to vehicle, if the 2-sided p-value of the ?2 test for ASF-1057 versus vehicle does not exceed 0.05 and the estimated response rate of ASF-1057 is larger than the vehicle response rate. If a statistically significant superiority to vehicle could be shown in step 1, then a statistically significantly superiority of ASF-1057 versus placebo will be concluded in step 2, if the 2-sided p-value of the ?2 test for ASF-1057 versus placebo does not exceed 0.05 and the estimated response rate of ASF-1057 is larger than the placebo response rate. This hierarchical testing procedure will constitute the confirmatory analysis. All other analyses will be regarded as exploratory. The p-value of the ?2 test for the comparison of the placebo and vehicle response rates will also be calculated. The | — |
Countries
Finland, France, Germany, Sweden, United Kingdom
Outcome results
None listed