NCT01137630

Two Topical K40 Formulations in Adults With Seborrhoeic Dermatitis (SD) of the Scalp

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.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Moberg Pharma AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Seborrhoeic Dermatitis of the Scalp

Interventions

Type	Name	Description
DRUG	K40a	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.
DRUG	K40b	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.
DRUG	Placebo	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.

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2010-06-04
• Last updated: 2010-06-04

Locations

11 sites across 1 country: Sweden