search
Back to results

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

Primary Purpose

Seborrhoeic Dermatitis of the Scalp

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
K40a
K40b
Placebo
Sponsored by
Moberg Pharma AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seborrhoeic Dermatitis of the Scalp focused on measuring seborrhoeic dermatitis, scalp, K40a, K40b

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dellenkliniken
  • Läkarhuset Farsta Centrum
  • Stortorgets Hälsocentral
  • Hedesunda Hälsocentral
  • Familjehälsan
  • Derbykliniken
  • Möllevångens Läkargrupp,
  • Möllevångens Läkargrupp
  • Department of Dermatology, Karolinska University Hospital
  • Hälsojouren
  • Österpraktiken

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

K40a

K40b

Placebo

Arm Description

K40a 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. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning.

K40b 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. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning.

Placebo 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. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning.

Outcomes

Primary Outcome Measures

Erythema and desquamation scores
Sum of erythema and desquamation scores at Week 4

Secondary Outcome Measures

Erythema and desquamation scores
Sum of erythema and desquamation scores at Week 2 and 8
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
Erythema score
Erythema score at Week 2, 4 and 8
Desquamation score
Desquamation score at Week 2, 4 and 8
Doctor's Global evaluation
Doctor's Global evaluation at Week 4 and 8
Patient's Global evaluation
Patient's Global evaluation at Week 4 and 8
Pruritus score
Patient's pruritus score at Week 2, 4 and 8
Dandruff score
Patient's dandruff score at Week 2, 4 and 8
Dermatology Life Quality Index
Dermatology Life Quality Index (DLQI) assessed by the patient at Week 4 and 8
Ease of application
Cosmetic properties; ease of application at Week 4 and 8
Stickiness
Cosmetic properties; stickiness at Week 4 and 8
Effect on hair quality
Cosmetic properties; effect on hair quality at Week 4 and 8
Adverse events
Adverse Events classified by body system and preferred term

Full Information

First Posted
June 3, 2010
Last Updated
June 3, 2010
Sponsor
Moberg Pharma AB
search

1. Study Identification

Unique Protocol Identification Number
NCT01137630
Brief Title
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

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Moberg Pharma AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seborrhoeic Dermatitis of the Scalp
Keywords
seborrhoeic dermatitis, scalp, K40a, K40b

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
K40a
Arm Type
Experimental
Arm Description
K40a 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. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning.
Arm Title
K40b
Arm Type
Experimental
Arm Description
K40b 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. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 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. Approximately one tablespoon of the respective formulation is to be applied before bed and to be washed out with the patient's normal shampoo in the morning.
Intervention Type
Drug
Intervention Name(s)
K40a
Other Intervention Name(s)
K301a
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
K40b
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Erythema and desquamation scores
Description
Sum of erythema and desquamation scores at Week 4
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Erythema and desquamation scores
Description
Sum of erythema and desquamation scores at Week 2 and 8
Time Frame
Weeks 2 and 8
Title
Responder
Description
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
Time Frame
Weeks 2, 4 and 8
Title
Erythema score
Description
Erythema score at Week 2, 4 and 8
Time Frame
Weeks 2, 4 and 8
Title
Desquamation score
Description
Desquamation score at Week 2, 4 and 8
Time Frame
Weeks 2, 4 and 8
Title
Doctor's Global evaluation
Description
Doctor's Global evaluation at Week 4 and 8
Time Frame
Week 4 and 8
Title
Patient's Global evaluation
Description
Patient's Global evaluation at Week 4 and 8
Time Frame
Weeks 4 and 8
Title
Pruritus score
Description
Patient's pruritus score at Week 2, 4 and 8
Time Frame
Weeks 2, 4 and 8
Title
Dandruff score
Description
Patient's dandruff score at Week 2, 4 and 8
Time Frame
Weeks 2, 4 and 8
Title
Dermatology Life Quality Index
Description
Dermatology Life Quality Index (DLQI) assessed by the patient at Week 4 and 8
Time Frame
Week 4 and 8
Title
Ease of application
Description
Cosmetic properties; ease of application at Week 4 and 8
Time Frame
Weeks 4 and 8
Title
Stickiness
Description
Cosmetic properties; stickiness at Week 4 and 8
Time Frame
Weeks 4 and 8
Title
Effect on hair quality
Description
Cosmetic properties; effect on hair quality at Week 4 and 8
Time Frame
Weeks 4 and 8
Title
Adverse events
Description
Adverse Events classified by body system and preferred term
Time Frame
Weeks 0, 2, 4 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lennart Emtestam, MD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dellenkliniken
City
Delsbo
Country
Sweden
Facility Name
Läkarhuset Farsta Centrum
City
Farsta
Country
Sweden
Facility Name
Stortorgets Hälsocentral
City
Gävle
Country
Sweden
Facility Name
Hedesunda Hälsocentral
City
Hedesunda
Country
Sweden
Facility Name
Familjehälsan
City
Hofors
Country
Sweden
Facility Name
Derbykliniken
City
Malmo
Country
Sweden
Facility Name
Möllevångens Läkargrupp,
City
Malmo
Country
Sweden
Facility Name
Möllevångens Läkargrupp
City
Malmo
Country
Sweden
Facility Name
Department of Dermatology, Karolinska University Hospital
City
Stockholm
Country
Sweden
Facility Name
Hälsojouren
City
Uppsala
Country
Sweden
Facility Name
Österpraktiken
City
Örebro
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs