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A randomized, Double-blind, Parallel-group Study of KAR in patients with head lice infestations that resistance to existing treatment

A randomized, Double-blind, Parallel-group Study of KAR in patients with head lice infestations that resistance to existing treatment

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031220028
Enrollment
198
Registered
2022-04-22
Start date
2022-07-16
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

head lice infestations that resistance to existing treatment

Interventions

Apply KAR lotion 0.5% or KAR 0%

Sponsors

Ishii Norihisa
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patient is at least 6 months of age at time of consent 2. Patients with at least 1 live head lice and at least 5 head lice eggs present on scalp and/or hair 3. Diagnosed as having head lice infestations that resistance to topical Phenothrin 0.4% or topical Dimethylpolysiloxane 4% 4. Patients who are able to participate in visit2 observation, examination, and investigation on the same day by all same household members with head lice infestations or suspected

Exclusion criteria

Exclusion criteria: 1. Do not live in fixed dwelling 2. Patients with same household member who fulfill inclusion criteria 2 but do not fulfill other inclusion criteria 3. Unable to apply appropriate drugs by the person or the same adult household member 4. Patients used ivermectin oral agents, topical phenotrin, topical dimethylpolysiloxane, and other drugs that are expected to be effective against head lice from 7 days before Visit2 to Visit2 5. Patients who have had their head lice physically wiped out with a comb after obtaining consent 6. Patients who have had a haircut or chemical treatment of the hair (hair dyeing, permanent wave, hair straightening) after obtaining consent

Design outcomes

Primary

MeasureTime frame
Successful treatment of the index human subject (Successful treatment : No live head lice in Visit 3 and Visit 4, maintained until Visit 5)

Contacts

Public ContactContact for Clinical Trial

Kaken Pharmaceutical Co. Ltd.

kaken-jrct@e-medinfo.com+81-120-391-004

Outcome results

None listed

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