Is Hedrin® 4% lotion Dev 42 more effective than Hedrin® 4% lotion against head louse eggs?

Phase 3

Completed

• Conditions: Head louse infestation; Infections and Infestations; Pediculosis and phthiriasis

• Registration Number: ISRCTN10431107
• Lead Sponsor: Thornton & Ross Ltd (UK)

Brief Summary

2009 results in https://www.ncbi.nlm.nih.gov/pubmed/19951427 (added 30/03/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2008-05-31
• Study Start: 2009-03-19
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Both males and females, aged 4 years 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 16 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

Exclusion Criteria

1. Participants with a known sensitivity to any of the ingredients in Hedrin® 4% lotion or Hedrin® 4% lotion Dev 42
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
<br> 1. To compare Hedrin® 4% lotion with Hedrin® 4% lotion Dev 42 with regard to inhibition of hatching of louse eggs (ovicidal activity): no nymphal lice emerging from eggs between treatments (i.e. on day 1, 2, or 6) or after the second treatment<br> 2. To compare the efficacy of Hedrin® 4% lotion with Hedrin® 4% lotion Dev 42 with regard to the eradication of head lice: assessed post-second treatment, i.e. no lice on days 9 or 14<br>

Secondary Outcome Measures

Name	Time	Method
To compare Hedrin® 4% lotion with Hedrin® 4% lotion Dev 42 with regard to safety, ease of application and participant acceptability, assessments made on days 0 and 7 post-treatment application and at each of the efficacy assessments on days 1, 2, 6, 9, and 14