A randomised, controlled, assessor-blind, clinical investigation of the activity of mosquito® LäuseShampoo compared with Infectopedicul® permethrin 0.5% lotion in the treatment of head lice - Comparing mosquito LauseShampoo with Infectopedicul lotio

Phase 1

• Conditions: MedDRA version: 9.1 Level: LLT Classification code 10019199 Term: Head pediculosis; Infestation by head lice (pediculosis capitis)

• Registration Number: EUCTR2010-019804-21-GB
• Lead Sponsor: Wepa Apothekenbedarf GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-04
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

1. Participants aged 2 years and over with no upper age limit.

2. Participants who upon examination, are confirmed to have at least five live head lice.

3. Participants who give written informed consent, or if the participant is below 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. People younger than 2 years

2. People with a known sensitivity to pyrethroid insecticides like permethrin, chrysanthemums, nuts, soya, or any of the ingredients in mosquito® LäuseShampoo or Infectopedicul® lotion.

3. People with asthma or a similar respiratory condition.

4. People 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).

5. People who have been treated with other head lice products within the previous two weeks.

6. People who have been treated with the antibiotics Co-Trimoxazole, Trimethoprim or any other medical treatment which could interfere with the study treatment within the previous four weeks, or who are currently taking such a course.

7. People who have bleached, permanently coloured, or permanent waved their hair within the previous four weeks.

8. People or parents / guardians not giving written consent or withdrawal of the written consent.

9. Pregnant or nursing mothers. Any potential participant in menses should confirm that they are not or not likely to be pregnant or are taking an appropriate form of contraception. In case of doubt a urine pregnancy test may be performed prior to entry.

10. People who have participated in another clinical study within 1 month before entry to this study.

11. People 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 non-inferiority of mosquito® LäuseShampoo in comparison with Infectopedicul® lotion in the eradication of head louse infestation.;<br> Secondary Objective: If there is sufficient margin in efficacy to detect superiority of efficacy of mosquito® LäuseShampoo over Infectopedicul® lotion in the eradication of head louse infestation.<br><br> To compare mosquito® LäuseShampoo with Infectopedicul® lotion with regard to safety, ease of application, and participant acceptability.<br> ;Primary end point(s): To investigate the non-inferiority of mosquito® LäuseShampoo in comparison with Infectopedicul® lotion in the eradication of head louse infestation.