Comparing mosquito® LäuseShampoo with Infectopedicul® lotion

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2010
INTERVENTION: Participants will be randomly divided into two equal groups. Half the participants (48) will receive mosquito® LäuseShampoo (modified coconut oil and soya oil based shampoo): the product is first used like an ordinary shampoo and partially towel dried. The product will be applied directly to the damp hair. Sufficient product will be applied to the hair and scalp that when thoroughly massaged in produces a homogenous and stable foam, which covers all the hair and the scalp. If no such foam is built, more product has to be applied. The foamed product will be left in place for 30 minutes (a shower cap will be used to secure the foam) before being rinsed off with warm water and towel dried. The product is then reapplied to produce a stable foam and left in place for a further 30 minutes (maximum dose 100 ml per treatment application). The product will be reapplied at Day 9. The other half (48) will receive Infectopedicul® 0.5% permethrin alcoholic lotion: The product will be applied directly to washed and towel dried hair. Sufficient product will be applied to saturate the hair and scalp (maximum dose 100 ml per application). The product will be left in place for 30 minutes before being rinsed off with warm water. The product will be reapplied at Day 9. CONDITION: Head louse infestation ; Infections and Infestations ; Pediculosis and phthiriasis PRIMARY OUTCOME: 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: 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; 2. To compare mosquito® LäuseShampoo with Infectopedicul® lotion with regard to the following factors:; 2.1. Safety of the products monitored by observation for adverse events on days 0, 2, 9, 11, and 14 of the study; 2.2. Ease of use by investigators, assessed by a questionnaire on the day of the first treatment; 2.3. Participant acceptability, assessed by a questionnaire at the assessment on day 2 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
Epistemonikos ID: a9443c6f74f21d26712fb17a3fbe169021b264db
First added on: Aug 22, 2024