A randomised, controlled, assessor-blind, clinical trial to demonstrate superiority of Hedrin 4% dimeticone lotion compared with Derbac-M 0.5% malathion aqueous liquid in the treatment of head lice - Is Hedrin 4% more effective than Derbac-M for the treatment of head lice?

Phase 1

• Conditions: Head louse infestation; MedDRA version: 14.1Level: LLTClassification code 10034214Term: Pediculus capitis (head louse)System Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2006-004136-73-GB
• Lead Sponsor: Thornton & Ross Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-16
• Last Update Posted: 21 August 2017

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 home visits by MEC 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 or Derbac-M liquid.

2. 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. 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 colour treated or permanently waved within the previous four weeks (wash in/wash out colours are acceptable).

5. Participants who have been treated with the antibiotics Co-Trimoxazole, Septrin 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