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Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
Sponsor: Perrigo CSCI
Summary
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). The most common symptom of infestation is pruritus (itching) on the head which normally intensifies 3 to 4 weeks after the initial infestation. The test item has been developed with the ambition to offer a complete head lice treatment, whilst also offering ultimate convenience in use - making treatment of head lice infestation easy, and effective in few minutes. The objectives of this clinical study are to assess the efficacy and the safety of a new Medical Device shampoo for lice infestation treatment compared to a comparator device, already in market.
Official title: Randomized Medical Device Class IIa Clinical Investigation to Assess the Safety and Efficacy of a New Shampoo for Head Lice Treatment
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2026-02
Completion Date
2026-05
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
INVESTIGATIONAL DEVICE, Paranix ® shampoo 2 minutes
New medical device shampoo for the treatment of head lice infestation: Paranix ® with 2 minute application time
INVESTIGATIONAL DEVICE, Paranix ® shampoo 5 minutes
New medical device shampoo for the treatment of head lice infestation: Paranix ®, with 5 minutes application time
COMPARATOR DEVICE, Pouxit ®
well established medical device shampoo for the treatment of head lice infestation - Pouxit ®
Locations (1)
CIDP
Phoenix, Mauritius