An interventional study of INVESTIGATIONAL DEVICE, Paranix ® shampoo 2 minutes and INVESTIGATIONAL DEVICE, Paranix ® shampoo 5 minutes in Headlice, sponsored by Perrigo CSCI. Not yet recruiting at 1 site in Mauritius. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Perrigo CSCI · Not applicable, Interventional, and 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.
Perrigo CSCI is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participant suspected to be non-compliant according to the Investigator's judgment.
Participant with curly hair (from 4A to 4C in the hair type scale).
Participant undergoing a topical treatment on the test area or a systemic treatment with:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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, 5 min treatment time : Paranix ®
Other: INVESTIGATIONAL DEVICE, Paranix ® shampoo 5 minutes
Head lice shampoo treatment (medical device class 1) already in market in europe: Pouxit ®
Other: COMPARATOR DEVICE, Pouxit ®
New medical device shampoo for the treatment of head lice infestation: Paranix ® with 2 minute application time
New medical device shampoo for the treatment of head lice infestation: Paranix ®, with 5 minutes application time
well established medical device shampoo for the treatment of head lice infestation - Pouxit ®
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.
Time frame: 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.
Time frame: 14 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: Day 1 , Day 7 or Day 14 if applicable
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for May 2026, 3 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Perrigo CSCI