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

A placebo-controlled, comparative study of KTZ-S 2% for Seborrhoeic dermatitis of the scalp

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250479

Enrollment

160

Registered

2025-11-11

Start date

2025-12-08

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seborrhoeic dermatitis of the scalp

Interventions

KTZ-S 2% once daily for 4 weeks placebo once daily for 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with seborrhoeic dermatitis of the scalp over 18 years old Malassezia fungi were detected of the lesions

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
TSS change for the entire scalp 4 weeks after the start of study treatment	—

Secondary

Measure	Time frame
(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	—

Measure

Time frame

(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

—

Contacts

Public ContactShigeto Mashimo

Seren Pharmaceuticals Inc.

mashimo@serenpharma.com+81-3-5244-9343

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026