Head Lice InfestationNCT06057506
Comparative Study for the Evaluation of Two Medical Devices on the Treatment of Head Lice Infestation
A study testing Paranix® Lotion in people with Head Lice Infestation, run by Perrigo CSCI at 1 site in Mauritius.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head Lice Infestation
- What is being tested?
- Paranix® Lotion
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteMauritius
- Study dates
- 21 Aug 2023to Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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 in an exclusion period from a previous study or who is currently participating in another study on hair/scalp or who participated to another clinical study on hair/scalp within 3 months before first visit;
- 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);
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- 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
- Subject 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 study;
- corticosteroids during the 2 previous weeks and during the study;
- retinoids and/or immunosuppressors during the 3 previous months and during the study;
- any medication stabilized for less than one month.
- Subject who received an anti-lice treatment in the previous 2 months.
Trial locations and contacts
1 site in 1 country.
Mauritius1 site, 1 recruiting
- Recruiting
Insight Research
Quatre Bornes
Manon Laune, +33 (0)4 72 82 36 56 4409, mla@dermscan.com
About this study
Official title: Comparative, Monocentric Study for the Evaluation of the Efficacy of Two Medical Devices on the Treatment of Head Lice Infestation
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
- Being tested
- Paranix® Shampoo, Paranix® Lotion
- Keywords
- Head Lice Infestation, Pediculosis capitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paranix® ShampooDevice
well established medical device for the treatment of head lice infestation (osmolone based)
Paranix® LotionDevice
well established medical device for the treatment of head lice infestation (dimethicone based)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Paranix® Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 7, Day 14 if applicable
Secondary outcomes (6)
Cure rate of each individual investigational device
Evaluate the cure rate of each individual investigational device
Measured: Day 7, Day 14
Cure rate after one dose of investigational device application
Comparison of the percentage of subjects cured after one dose of the investigational device compared to the percentage of subjects cured with one dose of the comparator device.
Measured: Day 7
Dead and live lice/nymphs after combing
Number of dead and live lice/nymphs collected on the anti-lice comb after treatment.
Measured: Day 0, Day 7 if applicable
Live lice and nymphs after application
Evaluation of the presence of live lice and nymphs, for both groups, without combing on hair and close to scalp
Measured: 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
Evaluation of the safety and tolerability of the investigational device versus comparator
Measured: Day 0, Day 1, Day 7, Day 8 if applicable, and Day 14 if applicable
Subject reported perceived acceptability, efficacy and subjective evaluation assessed via questionnaire
Evaluation of the perceived acceptability, subjective efficacy and risk of re-infestation;
Subject perception questionnaire with the following scale items:
totally agree, agree, rather disagree, disagree
Measured: Day 1, Day 7 or Day 14 if applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start21 Aug 2023
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Lice InfestationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perrigo CSCI
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aslham Doarika, PhD, Principal investigator, Insight Collective
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057506
- Sponsor's protocol ID
- 22E1852
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Monocentric Study for the Evaluation of the Efficacy of Two Medical Devices on the Treatment of Head Lice Infestation
- ClinicalTrials.gov ID
- NCT06057506
- Acronym / sponsor ID
- 22E1852
- Conditions
- Head Lice Infestation
- Keywords
- Head Lice Infestation, Pediculosis capitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Perrigo CSCIIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Device | Experimental | Device: Paranix® ShampooMedical 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. |
| Comparator Device | Active comparator | Device: Paranix® LotionMedical 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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);
Key exclusion criteria (22 listed)
- 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 in an exclusion period from a previous study or who is currently participating in another study on hair/scalp or who participated to another clinical study on hair/scalp within 3 months before first visit;
- Subject suspected to be non-compliant according to the investigator's judgment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paranix® Shampoowell established medical device for the treatment of head lice infestation (osmolone based) | Device | Investigational Device |
| Paranix® Lotionwell established medical device for the treatment of head lice infestation (dimethicone based) | Device | Comparator Device |
Primary outcome
Efficacy based on the cure rate after complete treatment
Time frame: Day 7, Day 14 if applicable
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).
6 secondary outcomes
Cure rate of each individual investigational device
Time frame: Day 7, Day 14
Cure rate after one dose of investigational device application
Time frame: Day 7
Dead and live lice/nymphs after combing
Time frame: Day 0, Day 7 if applicable
Live lice and nymphs after application
Time frame: 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
Time frame: Day 0, Day 1, Day 7, Day 8 if applicable, and Day 14 if applicable
Subject reported perceived acceptability, efficacy and subjective evaluation assessed via questionnaire
Time frame: Day 1, Day 7 or Day 14 if applicable
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Head Lice Infestation
Recruiting
Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).
Lice; Head Lice
Not yet recruiting
Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
Headlice
Not yet recruiting
Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.
Lice; Head Lice
Recruiting
Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo
Head Lice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aslham Doarika, PhD principal investigator
Insight Collective
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paranix® Lotion in people with Head Lice Infestation, run by Perrigo CSCI at 1 site in Mauritius.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mauritius. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manon Laune (+33 (0)4 72 82 36 56 4409, mla@dermscan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy based on the cure rate after complete treatment (time frame: Day 7, Day 14 if applicable). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.