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

NCT06057506 | Unknown

• 1 other identifier: 22E1852
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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 items have been developed with the ambition to offer a complete head lice treatment, whilst also offering ultimative convenience in use - making treatment of head lice infestation easy, and effective in few minutes. The main objective of this clinical study is to confirm the efficacy on head lice treatment of two Medical Devices, already in market.

Conditions

Head Lice Infestation

Keywords

Head Lice Infestation; Pediculosis capitis

Outcome Measures

Primary Outcomes (1)

• Efficacy based on the cure rate after complete treatment

  The cure rate is defined as the rate of subjects having no live lice on hair 7 days after the last application of the product (Day 7 or Day 14 if second application is needed).

  Day 7, Day 14 if applicable

Secondary Outcomes (6)

• Cure rate of each individual investigational device

  Day 7, Day 14

• Cure rate after one dose of investigational device application

  Day 7

• Dead and live lice/nymphs after combing

  Day 0, Day 7 if applicable

• Live lice and nymphs after application

  Day 1, Day 7, Day 8 if applicable, Day 14 if applicable

• Number of participants with treatment-related adverse events, serious adverse events as assessed by investigator

  Day 0, Day 1, Day 7, Day 8 if applicable, and Day 14 if applicable

Study Arms (2)

Investigational Device

EXPERIMENTAL

Medical device for the treatment of head lice infestation: Paranix® Shampoo, already in the market in Europe Single topical application administered to hair and scalp for 10 minutes. Applied by principal investigator on site.

Device: Paranix® Shampoo

Comparator Device

ACTIVE COMPARATOR

Medical device for the treatment of head lice infestation: Paranix® Lotion, already in the market in Europe Single topical application administered to hair and scalp for 10 minutes. Applied by principal investigator on site.

Device: Paranix® Lotion

Interventions

Paranix® Shampoo DEVICE

well established medical device for the treatment of head lice infestation (osmolone based)

Investigational Device

Paranix® Lotion DEVICE

well established medical device for the treatment of head lice infestation (dimethicone based)

Comparator Device

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Perrigo CSCI: lead

Study Sites (1)

Insight Research

Quatre Bornes, Mauritius

RECRUITING

Study Officials

• Aslham Doarika, PhD

  Insight Collective

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manon Laune

CONTACT

+33 (0)4 72 82 36 56 4409; mla@dermscan.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 28, 2023
• Study Start: August 21, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)