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

NCT01137630 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2010-06-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Moberg Pharma AB

    lead INDUSTRY

Principal Investigators

  • Lennart Emtestam, MD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • Sweden

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01137630 on ClinicalTrials.gov