seborrhoeic dermatitis of the scalp MedDRA version: 9.1 Level: LLT Classification code 10039794 Term: Seborrhoeic dermatitis capitis
Conditions
Interventions
Product Name: Kaprolac K301
Product Code: K301
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: propylene glycol
CAS Number: 57-55-6
Concentration unit: % percent
Concentration type: equal
Sponsors
Moberg Derma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female (including fertile women) • 18-70 years of age • SE of the scalp for at least 2 months • Presenting erythema and desquamation of mild to moderate 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • SE or any other cutaneous disease of the face or scalp requiring a specific topical treatment (corticosteroids, antifungals, selenium sulphide, 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 • SE associated with Parkinson’s disease, human immunodeficiency virus (HIV) 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 • Subject who has been previously enrolled in the phase II study K40-3 investigating Kaprolac® K40
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the efficacy of K301 compared to placebo after 4 weeks treatment in adults with Seborrhoeic Dermatitis of the scalp. The primary efficacy variable is the sum of erythema and desquamation scores at week 4.;Secondary Objective: Secondary efficacy objectives are to evaluate the efficacy after 2 and 4 weeks of treatment with K301 compared to placebo and to assess safety and tolerability of K301 in adults with Seborrhoetic Dermatitis of the scalp. The secondary efficacy variables are: • Sum of erythema and desquamation scores at Week 2 • Erythema score at Week 2 and 4 • Desquamation score at Week 2 and 4 • Investigator’s Global evaluation at Week 4 • Patient’s Global evaluation at Week 4 • Patient’s pruritus/burning score at Week 2 and 4 • Patient’s dandruff score at Week 2 and 4 ;Primary end point(s): The primary efficacy variable is the sum of erythema and desquamation scores at week 4. | — |
Countries
Sweden
Outcome results
None listed