Seborrhoeic Dermatitis of the scalp. MedDRA version: 8.1 Level: LLT Classification code 10039794 Term: Seborrhoeic dermatitis capitis
Conditions
Interventions
Product Name: Kaprolac K40a
Product Code: K40a
Pharmaceutical Form: Cutaneous solution
CAS Number: 57-55-6
Other descriptive name: PROPYLENE GLYCOLE
Concentration unit: mg/ml milligram(s)/millilitre
C
Sponsors
Moberg Derma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Male or female · 18-65 years of age · SD of the scalp for at least 2 months · Presenting erythema and desquamation of mild, moderate, pronounced or severe intensity · Signed written informed consent 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
Exclusion criteria: · Scalp SD requiring an antifungal, selenium sulphite or corticosteroid therapy · Any other cutaneous disease of the face requiring a specific topical treatment (corticosteroids, antifungals, antibiotics, retinoids, benzoyl peroxide or a-hydroxyacids) during the previous 15 days · Oral treatment with cyclines, lithium, antifungals or inhaled corticosteroids during the previous month · Use of systemic corticosteroids and retinoids during the previous 2 months · SD associated with Parkinson’s disease, human immunodeficiency virus infection · Current or any history of ear, nose and throat carcinoma, · Current or any history of severe concomitant disease according to Investigator’s judgement · Allergy to any of the tested treatment components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy variable is the sum of erythema and desquamation scores at Week 4. ;Main Objective: The primary objective of the study is to evaluate the efficacy of K40 (K40a and K40b combined) compared to placebo after 4 weeks treatment. The primary efficacy variable is the sum of erythema and desquamation scores at Week 4. The efficacy of the study product K40-a (which is composed of the active substances propylene glycol and lactic acid, together with the excipients urea, glycerol and water), and the efficacy of the study product K40-b (that has the same composition as K40-a with the addition of isopropanol) will be compared to the efficacy of placebo solution.;Secondary Objective: Secondary efficacy objectives are to evaluate the efficacy after 2, 4 and 8 weeks of treatment of K40 (K40a and K40b combined) compared to placebo, to assess safety and tolerability of K40a and K40b and to compare cosmetic properties of K40a and K40b. Secondary efficacy variables: · Sum of erythema and desquamation scores at Week 2 and 8. · Responder defined as a patient with complete remission (sum of erythema and desquamation scores=0) or partial remission (sum of scores=1 or 2) · Erythema score at Week 2, 4 and 8. · Desquamation score at Week 2, 4 and 8. · Doctor’s Global evaluation at Week 4 and 8. · Patient’s Global evaluation at Week 4 and 8. · Patient’s pruritus score at Week 2, 4 and 8. · Patient’s dandruff score at Week 2, 4 and 8. | — |
Countries
Sweden
Outcome results
None listed