NIPH Clinical Trials Search

A phase III of KTZ-S 2% for Seborrhoeic dermatitis of the scalp

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Seborrhoeic dermatitis of the scalp
Date of first enrollment	08/12/2025
Target sample size	160
Countries of recruitment
Study type	Interventional
Intervention(s)	KTZ-S 2% once daily for 4 weeks placebo once daily for 4 weeks

Outcome(s)

Primary Outcome

TSS change for the entire scalp 4 weeks after the start of study treatment

Secondary Outcome

(1) Percentage of subjects achieving negative Malassezia fungi at each evaluation time point (percentage of subjects with fewer than 10 Malassezia fungi per field of view under direct microscopic examination at 400x magnification) (2) Change in erythema score, change in scaling score (entire scalp and lesion site), change in pruritus score at each evaluation time point (3) Change in lesion extent score at each evaluation time point

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Patients with seborrhoeic dermatitis of the scalp over 18 years old Malassezia fungi were detected of the lesions
Exclude criteria	Patients complicated with diseases considered inappropriate for participation in clinical trials such as serious cardiac / hepatic / renal / pulmonary / hematologic disease Patients with atopic dermatitis, psoriasis vulgaris, contact dermatitis, and inflammatory skin diseases other than seborrhoeic dermatitis of the scalp