NCT07191457

Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo

In Vivo Testing: A Two-Arm, Randomized, Controlled, Investigator/Assessor-Blinded, Comparative Study to Evaluate the Safety and Efficacy of a Head Lice Physically Acting Product: ELIMAX GREEN LOTION EMOGREEN (X92001752) vs Walgreens Lice Killing Shampoo (Piperonyl Butoxide (4%),Pyrethrum Extract (Equivalent to 0.33% Pyrethrins)) in Subjects With Head Lice.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Oystershell NV · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Head Lice

Interventions

Type	Name	Description
DEVICE	Elimax Green Lotion with Emogreen	STEP 1: Apply the lotion to dry hair, completely saturating hair and scalp. Use a towel to cover eyes and exposed skin areas. Massage from the roots to the tips, paying particular attention to the area behind the ears and the hairline at the back of the head. Leave the lotion in the hair for 10 minutes (no longer). In the case of long hair, pin the hair up away from the skin after application. STEP 2: Wash out by applying shampoo to the hair and rinsing thoroughly. Repeat if needed to fully rinse out the lotion. STEP 3: Comb to remove lice and nits. Part the hair into sections and comb one section at a time. Place the teeth of the comb as close as possible to the scalp and comb away from the scalp to the end of the hair. Use clips to pin back each section of combed hair. Clean the comb during use by wiping onto a tissue. Discard the tissue into a sealable bag. Discard the sealed bag. Check hair for the following 7 to 10 days. If lice or nits are present, repeat steps 1-3.
DRUG	Walgreens Lice Killing Shampoo	Apply thoroughly to dry hair or other affected area. For head lice, first apply behind ears and to back of neck Allow product to remain for 10 minutes, but no longer Use warm water to form a lather, shampoo, then thoroughly rinse For head lice, towel dry hair and comb out tangles Remove lice and their eggs (nits) Use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove) Hair should remain slightly damp while removing nits If hair dries during combing, dampen slightly with water For head lice, part hair into sections. Do one section at a time starting at the top of the head. Longer hair may take 1 to 2 hours. Lift a 1- to 2- inch wide strand of the hair. Place comb as close as possible to the scalp and comb with a firm, even motion away from the scalp. Pin back each strand of the hair after combing Clean comb often. Wipe away nits with tissue and discard in a plastic bag. Seal bag and discard bag to prevent lice from coming back.

Timeline

• Start date: 2025-10-02
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2025-09-24
• Last updated: 2025-09-24

Locations

1 site across 1 country: United States