Seborrhoeic Dermatitis of the Scalp Clinical Trial
Official title:
A Multicenter, Randomised Double Blind, Placebo Controlled Study of Efficacy, Safety and Tolerability of Two Topical K40 Formulations in Adults With Seborrhoeic Dermatitis (SD) of the Scalp.
| Verified date | June 2010 |
| Source | Moberg Derma AB |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Medical Products Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 98 |
| Est. completion date | May 2007 |
| Est. primary completion date | May 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Dellenkliniken | Delsbo | |
| Sweden | Läkarhuset Farsta Centrum | Farsta | |
| Sweden | Stortorgets Hälsocentral | Gävle | |
| Sweden | Hedesunda Hälsocentral | Hedesunda | |
| Sweden | Familjehälsan | Hofors | |
| Sweden | Derbykliniken | Malmo | |
| Sweden | Möllevångens Läkargrupp | Malmo | |
| Sweden | Möllevångens Läkargrupp, | Malmo | |
| Sweden | Österpraktiken | Örebro | |
| Sweden | Department of Dermatology, Karolinska University Hospital | Stockholm | |
| Sweden | Hälsojouren | Uppsala |
| Lead Sponsor | Collaborator |
|---|---|
| Moberg Derma AB |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Erythema and desquamation scores | Sum of erythema and desquamation scores at Week 4 | Week 4 | No |
| Secondary | Erythema and desquamation scores | Sum of erythema and desquamation scores at Week 2 and 8 | Weeks 2 and 8 | No |
| Secondary | Responder | 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 | Weeks 2, 4 and 8 | No |
| Secondary | Erythema score | Erythema score at Week 2, 4 and 8 | Weeks 2, 4 and 8 | No |
| Secondary | Desquamation score | Desquamation score at Week 2, 4 and 8 | Weeks 2, 4 and 8 | No |
| Secondary | Doctor's Global evaluation | Doctor's Global evaluation at Week 4 and 8 | Week 4 and 8 | No |
| Secondary | Patient's Global evaluation | Patient's Global evaluation at Week 4 and 8 | Weeks 4 and 8 | No |
| Secondary | Pruritus score | Patient's pruritus score at Week 2, 4 and 8 | Weeks 2, 4 and 8 | No |
| Secondary | Dandruff score | Patient's dandruff score at Week 2, 4 and 8 | Weeks 2, 4 and 8 | No |
| Secondary | Dermatology Life Quality Index | Dermatology Life Quality Index (DLQI) assessed by the patient at Week 4 and 8 | Week 4 and 8 | No |
| Secondary | Ease of application | Cosmetic properties; ease of application at Week 4 and 8 | Weeks 4 and 8 | No |
| Secondary | Stickiness | Cosmetic properties; stickiness at Week 4 and 8 | Weeks 4 and 8 | No |
| Secondary | Effect on hair quality | Cosmetic properties; effect on hair quality at Week 4 and 8 | Weeks 4 and 8 | No |
| Secondary | Adverse events | Adverse Events classified by body system and preferred term | Weeks 0, 2, 4 and 8 | Yes |