Comparison of phenothrin mousse, phenothrin lotion and wet-combing for head lice

A randomised controlled assessor-blind parallel group clinical trial to assess the efficacy, safety and acceptability of phenothrin mousse, phenothrin lotion and wet-comb technique in the eradication of head lice

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN73201839

Enrollment

266

Registered

2013-07-30

Start date

1997-06-14

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Head louse (Pediculus capitis) infestation Infections and Infestations Pediculosis due to Pediculus humanus capitis

Interventions

1. d-phenothrin 0.5% mousse in an alcohol/water emulsifying wax base plus butane propellant supplied in 50mL pressurised containers, used once by application to dry hair for 30 minutes followed by sha

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males and females over the age of 4 who are suffering from head lice 2. People who give written informed consent or, if the person is under 18 years of age, whose guardians give written informed consent to participate in the study 3. People who are available for visits from the research investigators over the following 28 days 4. People who have an adult/guardian who is able to treat or comb the hair (depending on the allocated treatment group)

Exclusion criteria

Exclusion criteria: 1. People with a known sensitivity to pyrethroid insecticides and/or chrysanthemums 2. People who have been treated with other head lice products within the last 4 weeks 3. People who have any persistent skin disorder of the scalp (i.e. eczema, chronic dermatitis, psoriasis) 4. People receiving treatment for asthma 5. People who have bleached hair, or hair which has been colour treated or permed within the last 4 weeks 6. Pregnant or nursing mothers 7. People who have participated in another clinical trial within 1 month prior to entry to this study 8. People who have already participated in this clinical trial 9. People who have been treated with antibiotics within the last 4 weeks

Design outcomes

Primary

Measure	Time frame
1. The between-treatment comparison of the number of participants with evidence of active head lice infestation 14 days after treatment. 2. In the case of the two insecticide-based treatments this meant that no lice should be found during the follow up assessments up to the 14th day after application of the product. 3. In the case of wet-combing this referred to the assessment on the 14th day after initiation of treatment and for 14 days thereafter, i.e. to the 28th day.	—

Measure

Time frame

1. The between-treatment comparison of the number of participants with evidence of active head lice infestation 14 days after treatment. 2. In the case of the two insecticide-based treatments this meant that no lice should be found during the follow up assessments up to the 14th day after application of the product. 3. In the case of wet-combing this referred to the assessment on the 14th day after initiation of treatment and for 14 days thereafter, i.e. to the 28th day.

—

Secondary

Measure	Time frame
Comparison between treatments with respect to occurrence of untoward effects, whether or not they are thought to be related to the study treatment.	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026