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

This study has been completed.
Sponsor:
Information provided by:
Moberg Derma AB
ClinicalTrials.gov Identifier:
NCT01137630
First received: June 3, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Seborrhoeic Dermatitis of the Scalp
Drug: K40a
Drug: K40b
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Further study details as provided by Moberg Derma AB:

Primary Outcome Measures:
  • Erythema and desquamation scores [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Sum of erythema and desquamation scores at Week 4


Secondary Outcome Measures:
  • Erythema and desquamation scores [ Time Frame: Weeks 2 and 8 ] [ Designated as safety issue: No ]
    Sum of erythema and desquamation scores at Week 2 and 8

  • Responder [ Time Frame: Weeks 2, 4 and 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Weeks 2, 4 and 8 ] [ Designated as safety issue: No ]
    Erythema score at Week 2, 4 and 8

  • Desquamation score [ Time Frame: Weeks 2, 4 and 8 ] [ Designated as safety issue: No ]
    Desquamation score at Week 2, 4 and 8

  • Doctor's Global evaluation [ Time Frame: Week 4 and 8 ] [ Designated as safety issue: No ]
    Doctor's Global evaluation at Week 4 and 8

  • Patient's Global evaluation [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
    Patient's Global evaluation at Week 4 and 8

  • Pruritus score [ Time Frame: Weeks 2, 4 and 8 ] [ Designated as safety issue: No ]
    Patient's pruritus score at Week 2, 4 and 8

  • Dandruff score [ Time Frame: Weeks 2, 4 and 8 ] [ Designated as safety issue: No ]
    Patient's dandruff score at Week 2, 4 and 8

  • Dermatology Life Quality Index [ Time Frame: Week 4 and 8 ] [ Designated as safety issue: No ]
    Dermatology Life Quality Index (DLQI) assessed by the patient at Week 4 and 8

  • Ease of application [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
    Cosmetic properties; ease of application at Week 4 and 8

  • Stickiness [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
    Cosmetic properties; stickiness at Week 4 and 8

  • Effect on hair quality [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
    Cosmetic properties; effect on hair quality at Week 4 and 8

  • Adverse events [ Time Frame: Weeks 0, 2, 4 and 8 ] [ Designated as safety issue: Yes ]
    Adverse Events classified by body system and preferred term


Enrollment: 98
Study Start Date: February 2007
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: K40a
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.
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.
Other Name: K301a
Experimental: K40b
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.
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.
Placebo Comparator: Placebo
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137630

Locations
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
Department of Dermatology, Karolinska University Hospital
Stockholm, Sweden
Hälsojouren
Uppsala, Sweden
Österpraktiken
Örebro, Sweden
Sponsors and Collaborators
Moberg Derma AB
Investigators
Principal Investigator: Lennart Emtestam, MD Karolinska University Hospital
  More Information

No publications provided

Responsible Party: Kjell Rensfeldt MD, Moberg Derma AB
ClinicalTrials.gov Identifier: NCT01137630     History of Changes
Other Study ID Numbers: K40-3
Study First Received: June 3, 2010
Last Updated: June 3, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by Moberg Derma AB:
seborrhoeic dermatitis
scalp
K40a
K40b

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Seborrheic
Sebaceous Gland Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 20, 2014