A skin irritation study of KMW-1 in healthy adults (phase 1)

A skin irritation study of KMW-1 in healthy adults (phase 1) - A skin irritation study of KMW-1 (phase 1)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030423

Enrollment

Registered

2017-12-16

Start date

2017-12-16

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

burn

Interventions

KMW-1(0.09 g/g),Placebo, Deionized water (negative-controlled) and Patch test unit only will be applied on the back (paraspinal site) of the study subjects for 4 hours, 8 hours and 12 hours by using a

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Health volunteers 2. Japanese 3. BMI of 18.5 to 25.0 (rounded to one decimal place)

Exclusion criteria

Exclusion criteria: 1. Does NOT have dermatological diseases such as dermatitis and eczema 2. Does NOT have history of skin rash from e.g. plaster or contact dermatitis metal, cosmetics or household appliance 3. Has a wound, scar, birthmark, or tattoo on the back (paraspinal sites) 4. Has a history of allergic reactions to medications, pineapple, papaya or specific constitutions (e.g. alcohol hypersensitivity) 5. Complicated with liver, kidney, heart diseases or hematological disorders or has a history of them 6. Regularly uses drugs 7. Has a history of drug abuse (narcotics/stimulants/psychotropics) or alcohol dependence

Design outcomes

Primary

Measure	Time frame
Skin irritability at 4 hours, 8 hours, 12hours, 24hours and 48 hours after administraion	—

Countries

Japan

Contacts

Public ContactKeita Shoshi

KAKEN PHARMACEUTICAL CO., LTD. Clinical Development Depertment

shoshi_keita@kaken.co.jp03-5977-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026