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

Phase 3
Recruiting
Conditions
head lice infestations that resistance to existing treatment
Registration Number
JPRN-jRCT2031220028
Lead Sponsor
Ishii Norihisa
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
198
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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