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

NCT07391059 | Not Yet Recruiting

• 1 other identifier: 2425CMPH047
• Study Type: interventional
• Target: 180
• 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 shampoo for lice infestation treatment compared to a comparator device, already in market.

Conditions

Headlice

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.

  7 days

• 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.

  14 days

Secondary Outcomes (5)

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

  Day 7

• Number of dead and live lice/nymphs after treatment

  Day 0 and Day 7 if applicable

• Number of live lice and nymphs, after application of treatment

  Day 1 and Day 8 if applicable

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

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

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

  Day 1 , Day 7 or Day 14 if applicable

Study Arms (3)

INVESTIGATIONAL DEVICE Paranix ® shampoo , 2 MINUTES

EXPERIMENTAL

New medical device shampoo for the treatment of head lice infestation, 2 min treatment time : Paranix ®

Other: INVESTIGATIONAL DEVICE, Paranix ® shampoo 2 minutes

INVESTIGATIONAL DEVICE Paranix ® shampoo, 5 MINUTES

EXPERIMENTAL

New medical device shampoo for the treatment of head lice infestation, 5 min treatment time : Paranix ®

Other: INVESTIGATIONAL DEVICE, Paranix ® shampoo 5 minutes

COMPARATOR DEVICE, Pouxit ® shampoo

ACTIVE COMPARATOR

Head lice shampoo treatment (medical device class 1) already in market in europe: Pouxit ®

Other: COMPARATOR DEVICE, Pouxit ®

Interventions

INVESTIGATIONAL DEVICE, Paranix ® shampoo 2 minutes OTHER

New medical device shampoo for the treatment of head lice infestation: Paranix ® with 2 minute application time

INVESTIGATIONAL DEVICE Paranix ® shampoo , 2 MINUTES

COMPARATOR DEVICE, Pouxit ® OTHER

well established medical device shampoo for the treatment of head lice infestation - Pouxit ®

COMPARATOR DEVICE, Pouxit ® shampoo

INVESTIGATIONAL DEVICE, Paranix ® shampoo 5 minutes OTHER

New medical device shampoo for the treatment of head lice infestation: Paranix ®, with 5 minutes application time

INVESTIGATIONAL DEVICE Paranix ® shampoo, 5 MINUTES

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy participant,
• Female or male participants,
• Aged 2 years and above (for participants in arms 1 and 2),
• Aged 3 years and above (for participants in arms 3) ,
• Participants with a slight to moderate lice infestation (According to EU norms: 0, 1, 2)
• Participants with various hair types (from 1 to 3C in the hair scale below) and hair length (from short to mid length hair not exceeding shoulder).
• Written informed consent for participants ≥18 years or legal guardian for participants \<18 years given freely and expressly before start of the clinical investigation.
• Participant/Participant's legal guardian is psychologically able to understand the clinical investigation related information and to give written informed consent.
• Participant/participant's legal guardian agreeing to follow the study requirements during the whole clinical investigation period.
• Females of childbearing potential and sexually active should use a contraceptive regimen recognized as effective at least 4 weeks before the beginning of the clinical investigation and during the entire clinical investigation.

You may not qualify if:

• Pregnant or nursing woman or planning a pregnancy during the clinical investigation;
• Participant who had been deprived of their freedom by an administrative or legal decision or major participant who is under guardianship;
• Participant in a social or sanitary establishment;
• Participant suspected to be non-compliant according to the Investigator's judgment.
• Participant allergic to any of the ingredients and/or materials of the intended to be used products (investigation device and anti-lice comb, comparative device, post-treatment shampoo).
• Participant with curly hair (from 4A to 4C in the hair type scale).
• Participant with hair length exceeding shoulder.
• Participants with more than 24 lice on the head.
• Participant suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the clinical investigation results.
• Participant with a cutaneous disease on the studied zone (scalp and hair).
• Severe scratches or open wounds/skin damage on the scalp (lice bites allowed however).
• Participant with a known or suspected allergy to one or more of the components of the investigational or comparator devices.
• Participant who has diabetes.
• Participant with known or suspected immune deficiency or autoimmune disease.
• Participant undergoing a topical treatment on the test area or a systemic treatment with:

Sponsors & Collaborators

• Perrigo CSCI: lead

Study Sites (1)

CIDP

Phoenix, 73408, Mauritius

Location

Study Officials

• Gitanjali PETKAR, Dermatologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nanda MUNGUR

CONTACT

+(230) 401 2600; n.mungur@cidp-cro.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: September 18, 2025
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)