Comparative Study for the Evaluation of a New Medical Device on the Treatment of Head Lice Infestation

NCT05379114 | Unknown

• 1 other identifier: 20E4084
• 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 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 for lice infestation treatment compared to a comparator device, already in market.

Conditions

Head Lice

Outcome Measures

Primary Outcomes (2)

• Cure Rate after complete treatment

  The cure rate is defined as the rate of subjects having no live lice on scalp 7 days after the last application of the product.

  day 7

• Cure Rate after complete treatment

  The cure rate is defined as the rate of subjects having no live lice on scalp 7 days after the last application of the product.

  day 14

Secondary Outcomes (5)

• Cure rate after one dose of Investigational device (ID)

  Day 7

• Dead and live lice/nymphs and number of eggs after combing

  Day 0 and Day 7 if applicable

• Live lice and nymphs, after application

  Day 1 and Day 8 if applicable

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

  Day 0, 7, 8 and 14 if applicable

• Subject reported perceived acceptability, effectiveness and subjective evaluation assessed via questionnaire data

  Day 7 or Day14

Study Arms (2)

INVESTIGATIONAL DEVICE

EXPERIMENTAL

new medical device for the treatment of head lice infestation: Paranix ®

Other: INVESTIGATIONAL DEVICE

COMPARATOR DEVICE

ACTIVE COMPARATOR

dimethicone based head lice treatment (medical device class 1) already in market in europe: Pouxit ®

Other: Comparator device

Interventions

INVESTIGATIONAL DEVICE OTHER

new medical device for the treatment of head lice infestation: Paranix ®

INVESTIGATIONAL DEVICE

Comparator device OTHER

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

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
• 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:

• In terms of population
• 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 (type 4a to 4c in the hair type scale above)
• 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 or comparator 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.

Sponsors & Collaborators

• Perrigo CSCI: lead

Study Sites (1)

Céline Lhéritier

Quatre Bornes, Mauritius

RECRUITING

Central Study Contacts

Céline Lhéritier

CONTACT

+33 (0)6 71 32 33 20; clh@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: May 6, 2022
• First Posted: May 18, 2022
• Study Start: May 18, 2022
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)