Two Topical K40 Formulations in Adults With Seborrhoeic Dermatitis (SD) of the Scalp
Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
Participant gender:
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.