A proof of concept clinical investigation to evaluate the activity of Hedrin® 4% gel in the treatment of head lice using a 1-hour application time

Not Applicable

Completed

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

• Registration Number: ISRCTN50373146
• Lead Sponsor: Thornton & Ross Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-13
• Study Completion: 2009-07-01
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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 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% 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