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

Perrigo

Status: Not yet enrolling

Conditions: Headlice

Treatments: Other: COMPARATOR DEVICE; Other: INVESTIGATIONAL DEVICE 5 MINUTES; Other: INVESTIGATIONAL DEVICE 2 MINUTES

Study type: Interventional

Funder types: Industry

Identifiers

NCT07391059

2425CMPH047

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

INVESTIGATIONAL DEVICE , 2 MINUTES

Experimental group

Description:

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

Treatment:

Other: INVESTIGATIONAL DEVICE 2 MINUTES

INVESTIGATIONAL DEVICE , 5 MINUTES

Experimental group

Description:

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

Treatment:

Other: INVESTIGATIONAL DEVICE 5 MINUTES

COMPARATOR DEVICE

Active Comparator group

Description:

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

Treatment:

Other: COMPARATOR DEVICE