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Completed

NCT Number: NCT01137630

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.

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Key information

Conditions

Seborrhoeic Dermatitis of the Scalp Dermatitis Dermatitis, Seborrheic Sebaceous Gland Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Dellenkliniken, Delsbo, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

K40a

Drug

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 names: K301a

K40b

Drug

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

Drug

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 outcomes

  1. Erythema and desquamation scores

    Time frame: Week 4

    Sum of erythema and desquamation scores at Week 4

Secondary outcomes

  1. Erythema and desquamation scores

    Time frame: Weeks 2 and 8

    Sum of erythema and desquamation scores at Week 2 and 8

  2. Responder

    Time frame: Weeks 2, 4 and 8

    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

  3. Erythema score

    Time frame: Weeks 2, 4 and 8

    Erythema score at Week 2, 4 and 8

  4. Desquamation score

    Time frame: Weeks 2, 4 and 8

    Desquamation score at Week 2, 4 and 8

  5. Doctor's Global evaluation

    Time frame: Week 4 and 8

    Doctor's Global evaluation at Week 4 and 8

  6. Patient's Global evaluation

    Time frame: Weeks 4 and 8

    Patient's Global evaluation at Week 4 and 8

  7. Pruritus score

    Time frame: Weeks 2, 4 and 8

    Patient's pruritus score at Week 2, 4 and 8

  8. Dandruff score

    Time frame: Weeks 2, 4 and 8

    Patient's dandruff score at Week 2, 4 and 8

  9. Dermatology Life Quality Index

    Time frame: Week 4 and 8

    Dermatology Life Quality Index (DLQI) assessed by the patient at Week 4 and 8

  10. Ease of application

    Time frame: Weeks 4 and 8

    Cosmetic properties; ease of application at Week 4 and 8

  11. Stickiness

    Time frame: Weeks 4 and 8

    Cosmetic properties; stickiness at Week 4 and 8

  12. Effect on hair quality

    Time frame: Weeks 4 and 8

    Cosmetic properties; effect on hair quality at Week 4 and 8

  13. Adverse events

    Time frame: Weeks 0, 2, 4 and 8

    Adverse Events classified by body system and preferred term

Sponsors and collaborators

Lead sponsor

Moberg Pharma AB

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jun 4, 2010
Registry last updated
Jun 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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