NCT07244523

Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.

Prospective, Comparative, Two-arms, Randomized, Controlled, Investigator/Assessor-blinded Study for the Evaluation of the Efficacy and Safety of a Medical Device With a Physical Mode of Action (X92001919) Versus Paranic Anti-lice Shampoo on the Treatment of Head Lice Infestation.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Oystershell NV · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

Comparison of the efficacy of a new medical device with a physical mode of action to Paranix anti-lice shampoo in the treatment of head lice infestation.

Detailed description

Pediculosis capitis or head lice infestation is a human medical condition caused by the infestation of the hair by the parasitic insect Pediculus humanus capitis (human head lice). When lice feed, they inject saliva into the scalp. The saliva is an anticoagulant which keeps blood from clotting making their feeding process easier. Many individuals experience an allergic reaction to the saliva, causing up to 50% of the population with head lice to itch. For this reason, the most common symptom of infestation is pruritus (itching) on the head. The bite reaction is very mild and it can be rarely seen between the hairs. In rare cases, the itch scratch cycle can lead to secondary infection. Swelling of the local lymph nodes and fever are rare. There are a range of interventions available for the management of head lice. The main stay of therapy has been largely dependent on insecticidal-based approaches for several decades. However, the accumulating evidence with resistance to frontline insecticidal treatments like pyrethrins, permethrin and malathion has led to a growing incentive to develop newer and more effective treatments to treat the condition safely \[3\]. Over the past couple of decades, alternative candidates have been introduced into the market, including products with a physical mode of action that works via dehydration and suffocation of the lice \[4-8\]. The tested product has been developed with the ambition to offer a complete and safe head lice treatment, highly effective against head lice and eggs, whilst also offering ultimate convenience in use - making treatment of head lice infestation easy, and effective in few minutes. This is a medical device, not yet on the market, with a physical mode of action of suffocation and dehydration. The comparator product, Paranix® Anti-Lice Shampoo, is a reference product with a physical mode of action, available on the market in Europe as a class I medical device. The main objective of the current study is to evaluate the efficacy and safety on head lice treatment of the device X92001919 versus Paranix® Anti-Lice Shampoo comparator.

Conditions

• Lice; Head Lice

Interventions

Type	Name	Description
DEVICE	Pulverize (X92001919)	Treatment at Day 0, Day 3 and Day 7 with the Pulverize Dry Shampoo formulation (X92001919)
DEVICE	Paranix Anti-Lice Shampoo	Treatment at Day 0 and Day 7 with the Paranix Anti-Lice Shampoo

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2025-11-24
• Last updated: 2025-11-24