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

June 3, 2010
June 3, 2010
February 2007
May 2007   (final data collection date for primary outcome measure)
Erythema and desquamation scores [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Sum of erythema and desquamation scores at Week 4
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Seborrhoeic Dermatitis of the Scalp
  • 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
  • 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.
  • 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.
    Intervention: Drug: K40a
  • 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.
    Intervention: Drug: K40b
  • 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
May 2007
May 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01137630
K40-3
No
Kjell Rensfeldt MD, Moberg Derma AB
Moberg Derma AB
Not Provided
Principal Investigator: Lennart Emtestam, MD Karolinska University Hospital
Moberg Derma AB
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP