A Pilot Study to Evaluate the Efficacy and Safety of Low-Strength Cryosim-1 (TRPM8 Agonist) Cream in Adults with Chronic Prurigo

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011008

Enrollment

Registered

2025-09-10

Start date

2023-06-14

Completion date

Unknown

Last updated

2025-09-22

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

Conditions

None listed

Interventions

Medical Device : Apply assigned cream three times daily (TID: morning, evening, bedtime) for 4 weeks to all target lesions

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =20 years. 2. Chronic prurigo per international consensus: - Chronic itch =6 weeks, and - Multiple pruriginous papules/nodules attributable to scratching, documented by clinical examination (typical distribution on arms/legs or trunk; morphology recorded). 3. Able to comply and provide IRB(Institution Review Board)-approved written consent. 4. Stable background therapy (if any) for =2 weeks prior to baseline.

Exclusion criteria

Exclusion criteria: • Active clinically significant infection. • Pregnancy or breastfeeding. • Known hypersensitivity to study products/components. • Any condition judged by investigator to make participation unsafe or impracticable.

Design outcomes

Primary

Measure	Time frame
Between-group difference (each Cryosim-1 dose vs vehicle) in change ) in PAS(Prurigo Activity Score) 0–11.	—

Secondary

Measure	Time frame
Within-group PAS(Prurigo Activity Score) change ;Itch NRS(Numeric rating scale);Treatment satisfaction ;TEWL(TransEpidermal Water Loss)/Corneometer changes ;DLQI(Dermatology Life Quality Index);Safety: Incidence/severity/relatedness of AEs(adverse event)	—

Countries

Korea, Republic of

Contacts

Public ContactHye One KIM

Hallym University Medical Center-Kangnam

hyeonekim@gmail.com+82-2-829-5221

Outcome results