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Shampoo to prevent head lice

A randomised, double-blind, cross-over, placebo controlled clinical trial to demonstrate the effectiveness of a product designed to protect against establishment of a head louse infestation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14615267
Enrollment
70
Registered
2015-04-30
Start date
2015-05-01
Completion date
Unknown
Last updated
2020-11-02

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

Conditions

Head louse infestation (pediculosis capitis) Infections and Infestations

Interventions

Elimax shampoo and placebo shampoo. Both preparations will be applied in the same way as a conventional hair washing shampoo by the parent/carer. All participants are first treated using Elimax lotion

Sponsors

Oystershell NV
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Potential participants attending school with no upper age limit, although they must be the youngest qualifying member of the household 2. Potential participants who upon examination, are confirmed to be at risk of infestation with head lice 3. Potential participants who give written informed consent, or if the participant is under 16 years of age whose parent/guardian gives written informed consent to participate in the study 4. Potential participants who will be available for home visits by MEC study team members over the 13 weeks of the study

Exclusion criteria

Exclusion criteria: 1. Potential participants with a known sensitivity to sesame, sesame oil, any of the ingredients in Elimax shampoo, Elimax lotion or the placebo shampoo preparations 2. Potential participants with a secondary bacterial infection of the scalp (e.g. impetigo) or who have a long term scalp condition (e.g. psoriasis of the scalp) 3. Pregnant or nursing mothers 4. Potential participants who have participated in another clinical study within 1 month before entry to this study 5. Potential participants who have already participated in this clinical study

Design outcomes

Primary

MeasureTime frame
Time to first infestation of head lice during the six week period of treatment

Secondary

MeasureTime frame
Secondary endpoints are: 1. Whether an infestation occurred during either of the the six week treatment periods (active or placebo) 2. The number of infestations occurring during either of the treatment periods

Countries

United Kingdom

Outcome results

None listed

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