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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Moberg Pharma AB

Current Primary Outcome: Erythema and desquamation scores [ Time Frame: Week 4 ]

Sum of erythema and desquamation scores at Week 4


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Erythema and desquamation scores [ Time Frame: Weeks 2 and 8 ]
    Sum of erythema and desquamation scores at Week 2 and 8
  • 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
  • Erythema score [ Time Frame: Weeks 2, 4 and 8 ]
    Erythema score at Week 2, 4 and 8
  • Desquamation score [ Time Frame: Weeks 2, 4 and 8 ]
    Desquamation score at Week 2, 4 and 8
  • Doctor's Global evaluation [ Time Frame: Week 4 and 8 ]
    Doctor's Global evaluation at Week 4 and 8
  • Patient's Global evaluation [ Time Frame: Weeks 4 and 8 ]
    Patient's Global evaluation at Week 4 and 8
  • Pruritus score [ Time Frame: Weeks 2, 4 and 8 ]
    Patient's pruritus score at Week 2, 4 and 8
  • Dandruff score [ Time Frame: Weeks 2, 4 and 8 ]
    Patient's dandruff score at Week 2, 4 and 8
  • Dermatology Life Quality Index [ Time Frame: Week 4 and 8 ]
    Dermatology Life Quality Index (DLQI) assessed by the patient at Week 4 and 8
  • Ease of application [ Time Frame: Weeks 4 and 8 ]
    Cosmetic properties; ease of application at Week 4 and 8
  • Stickiness [ Time Frame: Weeks 4 and 8 ]
    Cosmetic properties; stickiness at Week 4 and 8
  • Effect on hair quality [ Time Frame: Weeks 4 and 8 ]
    Cosmetic properties; effect on hair quality at Week 4 and 8
  • Adverse events [ Time Frame: Weeks 0, 2, 4 and 8 ]
    Adverse Events classified by body system and preferred term


Original Secondary Outcome: Same as current

Information By: Moberg Pharma AB

Dates:
Date Received: June 3, 2010
Date Started: February 2007
Date Completion:
Last Updated: June 3, 2010
Last Verified: June 2010