Seborrhoeic Dermatitis of the Scalp
Conditions
Keywords
seborrhoeic dermatitis, scalp, K40a, K40b
Brief summary
Seborrhoeic dermatitis (SD) is a papulosquamous (presence of both papules and scales) disorder patterned on the sebum-rich areas of the scalp, face, and trunk. The current treatment does not cure the disease permanently. Therefore it must be repeated when the symptoms recur, or even prophylactically. Corticosteroids and antifungals are the mainstay of therapy. Topical corticosteroids rapidly reduce the cutaneous signs of disease, but are associated with a high frequency of relapse when treatment is stopped. They are reserved for acute flare-ups only as they may precipitate recurrences and dependence. In addition, chronic use of corticosteroids is associated with side-effects. The scientific rationale for the use of K40 for treatment of SD was based on clinical evidence that K40 improves erythema and desquamation with mild adverse reactions in a few cases. The primary objective of the study was to evaluate the efficacy of K40 (K40a and K40b combined) compared to placebo after 4 weeks treatment as measured by the sum of erythema and desquamation scores at Week 4.
Interventions
DRUGK40a
One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week.
DRUGK40b
One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week.
DRUGPlacebo
One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week.
Sponsors
Moberg Pharma AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female (including fertile women) * 18-65 years of age * Seborrhoeic dermatitis of the scalp for at least 2 months * Presenting erythema and desquamation of mild, moderate, pronounced or severe intensity * Signed written informed consent
Exclusion criteria
* Patient on an antifungal, selenium sulphite or corticosteroid therapy within the last 2 weeks prior to start of study treatment * 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'sjudgement * Allergy to any of the tested treatment components
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erythema and desquamation scores | Week 4 | Sum of erythema and desquamation scores at Week 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder | Weeks 2, 4 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) at Week 2, 4 and 8 |
| Erythema score | Weeks 2, 4 and 8 | Erythema score at Week 2, 4 and 8 |
| Desquamation score | Weeks 2, 4 and 8 | Desquamation score at Week 2, 4 and 8 |
| Doctor's Global evaluation | Week 4 and 8 | Doctor's Global evaluation at Week 4 and 8 |
| Patient's Global evaluation | Weeks 4 and 8 | Patient's Global evaluation at Week 4 and 8 |
| Pruritus score | Weeks 2, 4 and 8 | Patient's pruritus score at Week 2, 4 and 8 |
| Erythema and desquamation scores | Weeks 2 and 8 | Sum of erythema and desquamation scores at Week 2 and 8 |
| Dermatology Life Quality Index | Week 4 and 8 | Dermatology Life Quality Index (DLQI) assessed by the patient at Week 4 and 8 |
| Ease of application | Weeks 4 and 8 | Cosmetic properties; ease of application at Week 4 and 8 |
| Stickiness | Weeks 4 and 8 | Cosmetic properties; stickiness at Week 4 and 8 |
| Effect on hair quality | Weeks 4 and 8 | Cosmetic properties; effect on hair quality at Week 4 and 8 |
| Adverse events | Weeks 0, 2, 4 and 8 | Adverse Events classified by body system and preferred term |
| Dandruff score | Weeks 2, 4 and 8 | Patient's dandruff score at Week 2, 4 and 8 |
Countries
Sweden
Outcome results
None listed