Clinical trial NCT01137630: Two Topical K40 Formulations in Adults With Seborrhoeic Dermatitis (SD) of the Scalp
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Seborrhoeic Dermatitis of the Scalp
Keywords: seborrhoeic dermatitis
scalp
K40a
K40b
Lead sponsor: Moberg Pharma AB
Sponsor class: INDUSTRY
First posted: 2010-06-04
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Erythema and desquamation scores
timeFrame: Week 4
Secondary outcomes:
measure: Erythema and desquamation scores
timeFrame: Weeks 2 and 8
measure: Responder
timeFrame: Weeks 2, 4 and 8
measure: Erythema score
timeFrame: Weeks 2, 4 and 8
measure: Desquamation score
timeFrame: Weeks 2, 4 and 8
measure: Doctor's Global evaluation
timeFrame: Week 4 and 8
measure: Patient's Global evaluation
timeFrame: Weeks 4 and 8
measure: Pruritus score
timeFrame: Weeks 2, 4 and 8
measure: Dandruff score
timeFrame: Weeks 2, 4 and 8
measure: Dermatology Life Quality Index
timeFrame: Week 4 and 8
measure: Ease of application
timeFrame: Weeks 4 and 8
measure: Stickiness
timeFrame: Weeks 4 and 8
measure: Effect on hair quality
timeFrame: Weeks 4 and 8
measure: Adverse events
timeFrame: Weeks 0, 2, 4 and 8
Other outcomes:
Locations:
city: Delsbo
country: Sweden
facility: Dellenkliniken
city: Farsta
country: Sweden
facility: Läkarhuset Farsta Centrum
city: Gävle
country: Sweden
facility: Stortorgets Hälsocentral
city: Hedesunda
country: Sweden
facility: Hedesunda Hälsocentral
city: Hofors
country: Sweden
facility: Familjehälsan
city: Malmo
country: Sweden
facility: Derbykliniken
city: Malmo
country: Sweden
facility: Möllevångens Läkargrupp,
city: Malmo
country: Sweden
facility: Möllevångens Läkargrupp
city: Stockholm
country: Sweden
facility: Department of Dermatology, Karolinska University Hospital
city: Uppsala
country: Sweden
facility: Hälsojouren
city: Örebro
country: Sweden
facility: Österpraktiken
Study officials:
affiliation: Karolinska University Hospital
name: Lennart Emtestam, MD
role: PRINCIPAL_INVESTIGATOR
References: