Hedrin® Once vs Lyclear® against head lice

Completed

Conditions: Head louse infestation
Infections and Infestations
Pediculosis due to Pediculus humanus capitis

Registration Number: ISRCTN88144046

Lead Sponsor: Thornton & Ross Ltd (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 84

Inclusion Criteria

1. Both males and females, aged 6 months and over with no upper age limit
2. People who upon examination, are confirmed to have live head lice
3. People 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. People 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® Once liquid gel or Lyclear® 1% permethrin creme rinse, pyrethroid insecticides, or plants related to dandelions or chrysanthemums.
2. People 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. People who have been treated with other head lice products within the previous two weeks
4. People who have bleached hair, or hair that has been permanently waved within the previous four weeks
5. People 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. People who have participated in another clinical study within one month before entry to this study
8. People who have already participated in this clinical study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To demonstrate cure of infestation, defined as no evidence of head lice. <br>1.1. For Hedrin® Once following a single 15 minute application up to day 14 <br>1.2. For Lyclear® creme rinse using two applications assessed between completion of the second application of treatment on day 7 and day 14 (the first treatment for both products being applied on day 0).

Secondary Outcome Measures

Name	Time	Method
1. To compare the efficacy of Hedrin® Once with Lyclear® creme rinse and to identify superiority of one product over the other if appropriate.<br>2. Safety of the products monitored by observation for adverse events on days 0, 1, 6, 7, 9, and 14 of the study