Head LiceNCT05379114
Comparative Study for the Evaluation of a New Medical Device on the Treatment of Head Lice Infestation
A study testing INVESTIGATIONAL DEVICE and Comparator device in people with Head Lice, 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
- What is being tested?
- INVESTIGATIONAL DEVICE and Comparator device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteMauritius
- Study dates
- 18 May 2022to Sep 2022
- 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
- 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
- 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 in an exclusion period from a previous study or who is currently participating to 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.
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- 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.
- 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
Céline Lhéritier
Quatre Bornes
Céline Lhéritier, +33671323320, clh@dermscan.com
Aslham DOARIKA, Dr
About this study
Official title: Comparative, Monocentric Study for the Evaluation of the Non-inferiority of a New Medical Device 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 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
- Being tested
- INVESTIGATIONAL DEVICE, Comparator device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVESTIGATIONAL DEVICEOther
new medical device for the treatment of head lice infestation: Paranix ®
Comparator deviceOther
well established medical device for the treatment of head lice infestation (dimethicone based) - Pouxit ®
| Study group | Role | What they receive |
|---|---|---|
| INVESTIGATIONAL DEVICE | Experimental | new medical device for the treatment of head lice infestation: Paranix ® Receives: Other: INVESTIGATIONAL DEVICE |
| COMPARATOR DEVICE | Active comparator | dimethicone based head lice treatment (medical device class 1) already in market in europe: Pouxit ® Receives: Other: Comparator device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: day 14
Secondary outcomes (5)
Cure rate after one dose of Investigational device (ID)
Comparison of the percentage of subjects cured after one dose of the investigational device compared to the percentage of subjects cured with two doses of the comparator device.
Measured: Day 7
Dead and live lice/nymphs and number of eggs after combing
Number of dead and live lice/nymphs and number of eggs collected on the anti-lice comb after treatment
Measured: Day 0 and 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 scalp
Measured: 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
Measured: Day 0, 7, 8 and 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 the following scale items:
totally agree agree rather agree rather disagree disagree
Measured: Day 7 or Day14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start18 May 2022
- Primary completionJul 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head LiceStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379114
- Sponsor's protocol ID
- 20E4084
- Status last verified
- May 2022
- First submitted
- 6 May 2022
- Last updated
- 1 Jun 2022
- 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 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Monocentric Study for the Evaluation of the Non-inferiority of a New Medical Device on the Treatment of Head Lice Infestation
- ClinicalTrials.gov ID
- NCT05379114
- Acronym / sponsor ID
- 20E4084
- Conditions
- Head Lice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Perrigo CSCIIndustry (pharma, biotech, devices)
- Study start
- 18 May 2022 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 18 May 2022 (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 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.
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 | Other: INVESTIGATIONAL DEVICEnew medical device for the treatment of head lice infestation: Paranix ® |
| COMPARATOR DEVICE | Active comparator | Other: Comparator devicedimethicone based head lice treatment (medical device class 1) already in market in europe: Pouxit ® |
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
- 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 (23 listed)
- 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 in an exclusion period from a previous study or who is currently participating to another study on hair/scalp or who participated to another clinical study on hair/scalp within 3 months before first visit.
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 |
|---|---|---|
| INVESTIGATIONAL DEVICEnew medical device for the treatment of head lice infestation: Paranix ® | Other | INVESTIGATIONAL DEVICE |
| Comparator devicewell established medical device for the treatment of head lice infestation (dimethicone based) - Pouxit ® | Other | COMPARATOR DEVICE |
Primary outcome
Cure Rate after complete treatment
Time frame: day 7
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.
Cure Rate after complete treatment
Time frame: day 14
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.
5 secondary outcomes
Cure rate after one dose of Investigational device (ID)
Time frame: Day 7
Dead and live lice/nymphs and number of eggs after combing
Time frame: Day 0 and Day 7 if applicable
Live lice and nymphs, after application
Time frame: Day 1 and Day 8 if applicable
Number of participants with treatment-related adverse events as assessed by investigator
Time frame: Day 0, 7, 8 and 14 if applicable
Subject reported perceived acceptability, effectiveness and subjective evaluation assessed via questionnaire data
Time frame: Day 7 or Day14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INVESTIGATIONAL DEVICE and Comparator device in people with Head Lice, 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 23 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 1 Jun 2022. 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 Céline Lhéritier (+33 (0)6 71 32 33 20, clh@dermscan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure Rate after complete treatment (time frame: day 7). The study lists 2 primary outcomes in all. 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 1 Jun 2022.