Comparing two medical devices for treating head lice

Comparative, Monocentric Study for the Evaluation of the Efficacy of Two Medical Devices on the Treatment of Head Lice Infestation

This study is testing two different products, Paranix® Shampoo and Paranix® Lotion, to see which one works better for treating head lice in people aged 2 and older.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 2 Years and up
• Sex: All
• Sponsor: Perrigo CSCI (industry)
• Locations: 1 site (Quatre Bornes)
• Trial ID: NCT06057506 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of two medical devices, Paranix® Shampoo and Paranix® Lotion, in treating head lice infestation, a common condition caused by the parasitic insect Pediculus humanus capitis. The trial aims to confirm the efficacy of these treatments, which are designed to provide a convenient and effective solution for patients suffering from head lice. Participants will include healthy individuals aged 2 years and older with a slight to moderate lice infestation. The study will assess the treatments' performance in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates include healthy individuals aged 2 years and older with a slight to moderate head lice infestation.

Not a fit: Patients with severe lice infestations or those who are pregnant or nursing may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective and convenient solution for patients dealing with head lice infestations.

How similar studies have performed: Other studies have shown success with similar treatments for head lice, indicating a potential for effective outcomes.

Eligibility criteria

Inclusion Criteria:

* Healthy subject;
* Sex: male or female;
* Age: 2 years and above;
* Subject with a slight to moderate lice infestation (according to EU norms);
* Subjects with various hair type (from 1 to 3C - hair scale) and hair length (from short to mid length hair, not exceeding shoulder);
* Documented oral informed consent for all subjects, including minors, given freely and expressly before the start of the study;
* Written informed consent for subjects ≥18 years or legal guardian for subjects \< 18 years given freely and expressly before start of the study;
* Written assent for subjects ≥12 to \<18 years;
* Subject/Subject's legal guardian is psychologically able to understand the study related information and to give written informed consent;
* Females of childbearing potential must have a negative pregnancy test before the beginning of the study.

Exclusion Criteria:

* Pregnant (confirmed by pregnancy test for women of childbearing potential) or nursing woman or planning a pregnancy during the study;
* Subject who had been deprived of their freedom by administrative or legal decision or adult subject who is under guardianship;
* Subject in a social or sanitary establishment;
* Subject in an exclusion period from a previous study or who is currently participating in another study on hair/scalp or who participated to another clinical study on hair/scalp within 3 months before first visit;
* Subject suspected to be non-compliant according to the investigator's judgment;
* Subject with curly or frizzy hair (from 4A to 4C in the hair type scale);
* Subject with hair length below the shoulder;
* Subjects with more than 24 lice on the head.

In terms of associated pathology

* Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results;
* Subject with a cutaneous disease on the studied zone (scalp and hair);
* Subject with severe scratches or open wounds/skin damages on the scalp (lice bites allowed however);
* Subject with a known or suspected allergy to any of the components/materials of the investigational devices, anti-lice comb or post-treatment shampoo;
* Subject who has diabetes (type 1 or 2);
* Subject with known or suspected immune deficiency or autoimmune disease.

Relating to previous or ongoing treatment

* Subject undergoing a topical treatment on the test area or a systemic treatment with:

  * anti-inflammatory medication and/or anti-histamines during the previous 2 weeks and during the study;
  * corticosteroids during the 2 previous weeks and during the study;
  * retinoids and/or immunosuppressors during the 3 previous months and during the study;
  * any medication stabilized for less than one month.
* Subject who received an anti-lice treatment in the previous 2 months.

Where this trial is running

Quatre Bornes

• Insight Research — Quatre Bornes, Mauritius (RECRUITING)

Study contacts

• Principal investigator: Aslham Doarika, PhD — Insight Collective
• Study coordinator: Manon Laune

Conditions: Head Lice Infestation, Pediculosis capitis