Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT07191457
Brief Summary:
Compare efficacy and safety of Elimax Green Lotion Emogreen (RID SUper Max Solution) to that of Walgreens Lice Killing Shampoo against headlice in infested individuals. Involved subjects aged 6 months and older, of both genders, with a confirmed diagnosis of head lice infestation are included. Local and global tolerability, skin and eye irritation are monitored throughout the study. Any adverse events will be monitored and recorded.
Detailed Description:
The primary objective of this study is to evaluate and compare efficacy and safety of X92001752 Emogreen with Walgreens Lice Killing Shampoo (Piperonyl Butoxide (4%), Pyrethrum Extract (Equivalent to 0.33% Pyrethrins)) against head lice (Pediculus capitis) in infested individuals. More specifically, the present study aims to confirm the clinical performance and safety of head lice treatment product: Elimax Green Lotion with Emogreen L15® (INCI C15-19 alkane) as main ingredient (X92001752). This product works in the same way as Elimax Green Lotion with Hemisqualane® (INCI hydrogenated farnesene) namely, by physically suffocating and dehydrating lice and their nits due to the presence of a bio-alkane and beeswax. They are generally combined with a lice comb in a procedure pack. Elimax Green Lotion is classified as Class I medical devices in Europe. In the US, the products are packaged with a lice comb and registered as a Lice Removal Kit, in accordance with 21 CFR 880.5960, which is 510(k)-exempt.
In line with US regulations, the guidelines for clinical trials of medical devices must be adhered to. The study will involve subjects aged 6 months and older, of both genders, with a confirmed diagnosis of head lice infestation. To support safety assessments, local and global tolerability, skin and ocular irritation, and adverse events (AEs) will be monitored and recorded.
Study:
NCT07191457
Study Brief:
Protocol Section:
NCT07191457