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

• Conditions: Head louse infestation (pediculosis capitis); MedDRA version: 9.1Level: LLTClassification code 10034214Term: Pediculus capitis (head louse)

• Registration Number: EUCTR2008-005787-13-GB
• Lead Sponsor: Thornton & Ross Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Participants 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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Participants with a known sensitivity to any of the ingredients in Hedrin 4% lotion.

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the activity of Hedrin 4% lotion with regard to elimination of infestation by head lice using a 1 hour application time.;Secondary Objective: 1. To investigate the activity of Hedrin 4% lotion with regard to prevention of louse egg hatching (ovicidal action) by monitoring the presence/absence of juvenile stages of lice following the first treatment using a 1 hour application.<br><br>2. To investigate Hedrin 4% lotion with regard to safety, ease of application and participant acceptability using a 1 hour application.<br>;Primary end point(s): The primary measure is elimination of head lice following the second application of product by checks on days 9 and 14 of the study.