TO-210 Phase 1 Study

JRCT ID: jRCT2071230128

Registered date:15/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acne Vulgaris
• Date of first enrollment: 29/03/2024
• Target sample size: 34
• Study type: Interventional

Intervention(s)

Cohort 1-3
Single dose application of TO-210 5% or Placebo
Cohort 4
Multiple dose application of TO-210 5% or Placebo once daily for 7 days

Outcome(s)

• Primary Outcome: Safety, Pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 49age old
• Gender: Both

Include criteria

-Japanese patients aged between 18 and 49 years at informed consent
-Patients with facial acne valgaris with an Investigator's Global Assessment (IGA) score of 2-4
-Patients with 5-100 inflammatory lesions (papules, pustules) on the face (including the nose)

Exclude criteria

-Patients with a history of serious diseases such as brain, liver, kidney, heart, lung, digestive system, blood, endocrine system, metabolic system and mental system, or those currently under treatment
-Patients whose acne symptoms suddenly changed within at least 12 weeks before screening
-Patients with other skin diseases (e.g., urticaria, atopic dermatitis) or skin infections (bacterial, fungal, or viral) that might interfere with the evaluation of acne or TO-210 safety, except for tinea pedis

Related Information

• Primary Sponsor: Natsui Kensuke