A proof of concept clinical investigation to evaluate the activity of Hedrin® liquid gel in the treatment of head lice using a 15 minutes application time
- Conditions
- Head louse infestationInfections and InfestationsPediculosis and phthiriasis
- Registration Number
- ISRCTN59227204
- Lead Sponsor
- Thornton & Ross Ltd (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 0
1. Both males and females, aged 6 months and over with no upper age limit
2. Participants who upon examination, are confirmed to have live head lice
3. Participants who give written informed consent, or if the participant is under 11 years of age whose parent/guardian gives written informed consent to participate in the study
4. Participants who will be available for follow-up visits by study team members over the 14 days following first treatment
1. Participants with a known sensitivity to any of the ingredients in Hedrin® liquid gel
2. Participants with a secondary bacterial infection of the scalp (e.g. impetigo) or who have an active long-term scalp condition (e.g. psoriasis of the scalp)
3. Participants who have been treated with other head lice products within the previous two weeks
4. Participants who have bleached hair, or hair that has been permanently waved within the previous four weeks
5. Participants who have been treated with the antibiotics co-trimoxazole or trimethoprim within the previous four weeks, or who are currently taking such a course
6. Pregnant or nursing mothers
7. Participants who have participated in another clinical study within 1 month before entry to this study
8. Participants who have already participated in this clinical study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cure of infestation, defined as no evidence of head lice, assessed between completion of the second application of treatment on day 7 and day 14 (the first treatment being applied on day 0).
- Secondary Outcome Measures
Name Time Method 1. Prevention of louse egg hatching (ovicidal action), defined as no 1st and 2nd stage nymphs found at assessments during the week following the first treatment or after the second application of treatment<br>2. Safety of the product monitored by observation for adverse events on days 0, 1, 6, 7, 9, and 14 of the study<br>3. Ease of use by investigators, assessed by a questionnaire on the day of the first treatment<br>4. Ease of washing from the hair, assessed by a participant questionnaire at the final assessment on day 14<br>5. Participant acceptability, assessed by a questionnaire at the final assessment on day 14