Comparing mosquito® LäuseShampoo with Infectopedicul® lotio

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 96

Inclusion Criteria

1. Both males and females 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 study team members over the 14 days following first treatment

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the non-inferiority of mosquito® LäuseShampoo in comparison with Infectopedicul® lotion in the eradication of head louse infestation, defined as no evidence of head lice, assessed between completion of the second application of treatment on day 9 and day 14 (the first treatment being applied on day 0).

Secondary Outcome Measures

Name	Time	Method
1. 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>2. To compare mosquito® LäuseShampoo with Infectopedicul® lotion with regard to the following factors:<br>2.1. Safety of the products monitored by observation for adverse events on days 0, 2, 9, 11, and 14 of the study<br>2.2. Ease of use by investigators, assessed by a questionnaire on the day of the first treatment<br>2.3. Participant acceptability, assessed by a questionnaire at the assessment on day 2