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

Randomized Medical Device Class IIa Clinical Investigation to Assess the Safety and Efficacy of a New Shampoo for Head Lice Treatment

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Headlice
• Intervention / Treatment: Other: INVESTIGATIONAL DEVICE, Paranix ® shampoo 2 minutes; Other: INVESTIGATIONAL DEVICE, Paranix ® shampoo 5 minutes; Other: COMPARATOR DEVICE, Pouxit ®

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nanda MUNGUR; Phone Number: +(230) 401 2600; Email: n.mungur@cidp-cro.com

Study Locations

• Mauritius
  • Phoenix, Mauritius, 73408
    • CIDP
    • Contact: Nanda MUNGUR; Phone Number: (230) 401 2600; Email: n.mungur@cidp-cro.com
    • Principal Investigator: Gitanjali PETKAR, Dermatologist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Female participants of childbearing potential, presenting with negative pregnancy test at inclusion.

Exclusion Criteria:

• 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 being in an exclusion period from a previous clinical investigation or who is currently participating to another clinical investigation on hair/scalp or who participated to another clinical clinical investigation on hair/scalp within 3 months before first visit.

• 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INVESTIGATIONAL DEVICE Paranix ® shampoo , 2 MINUTES; New medical device shampoo for the treatment of head lice infestation, 2 min treatment time : Paranix ®	Other: INVESTIGATIONAL DEVICE, Paranix ® shampoo 2 minutes; New medical device shampoo for the treatment of head lice infestation: Paranix ® with 2 minute application time
Experimental: INVESTIGATIONAL DEVICE Paranix ® shampoo, 5 MINUTES; New medical device shampoo for the treatment of head lice infestation, 5 min treatment time : Paranix ®	Other: INVESTIGATIONAL DEVICE, Paranix ® shampoo 5 minutes; New medical device shampoo for the treatment of head lice infestation: Paranix ®, with 5 minutes application time
Active Comparator: COMPARATOR DEVICE, Pouxit ® shampoo; Head lice shampoo treatment (medical device class 1) already in market in europe: Pouxit ®	Other: COMPARATOR DEVICE, Pouxit ®; well established medical device shampoo for the treatment of head lice infestation - Pouxit ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure rate after one dose of Investigational device (ID)	Comparison of the percentage of participants cured after one dose of the investigational device at 2 minutes compared to the percentage of participants cured with the investigational device at 5 minutes ( after one dose) , compared to the percentage of participants cured with one dose and two doses of the comparator device.	Day 7
Number of dead and live lice/nymphs after treatment	Assessment of the effect of the investigational shampoo on head lice infestation, measured by the number of dead and live lice/nymphs, and the presence of live or unbroken nits collected randomly from the anti-lice comb after treatment. Counting will be done visually using dermatoscope.	Day 0 and Day 7 if applicable
Number of live lice and nymphs, after application of treatment	Assessment of the effect of the investigational shampoo on head lice infestation, measured by the number of dead and live lice/nymphs, and the presence of live or unbroken nits collected randomly from the anti-lice comb one day after treatment. Counting will be done visually using dermatoscope.	Day 1 and Day 8 if applicable
Number of participants with treatment-related adverse events as assessed by investigator	Evaluation of the safety and tolerability of the investigational device versus comparator	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	Evaluation of the perceived acceptability, effectiveness and subjective evaluation. Subject perception questionnaire with: A questionnaire at day 1 consisting of 16 questions with a 4-levels scale (strongly disagree , disagree, agree, strongly agree) and 2 questions with a binary scale (yes, no).; A questionnaire at end of study (day 7 or day 14) consisting of 9 questions with a 4-levels scale (strongly disagree , disagree, agree, strongly agree) and 4 questions with a binary scale (yes, no).	Day 1 , Day 7 or Day 14 if applicable

Collaborators and Investigators

• Sponsor: Perrigo CSCI
• Investigators: Principal Investigator: Gitanjali PETKAR, Dermatologist

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: September 18, 2025
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2425CMPH047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No