An interventional study of Paranix® Shampoo and Paranix® Lotion in Head Lice Infestation, sponsored by Perrigo CSCI. Recruiting at 1 site in Mauritius. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-28.
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 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.
43 studies on the registry are indexed under Lice Infestations; 4 are open to participants now.
This study's planned enrollment of 136 is above the median of 105 across 42 interventional studies indexed under Lice Infestations.
Browse Lice Infestations studies →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:
In terms of associated pathology
Relating to previous or ongoing treatment
Subject 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.
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.
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.
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.
Device: Paranix® Shampoo
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.
Device: Paranix® Lotion
well established medical device for the treatment of head lice infestation (osmolone based)
well established medical device for the treatment of head lice infestation (dimethicone based)
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).
Time frame: Day 7, Day 14 if applicable
Cure rate of each individual investigational device
Evaluate the cure rate of each individual investigational device
Time frame: 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.
Time frame: Day 7
Dead and live lice/nymphs after combing
Number of dead and live lice/nymphs collected on the anti-lice comb after treatment.
Time frame: 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
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
Evaluation of the safety and tolerability of the investigational device versus comparator
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
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
Time frame: Day 1, Day 7 or Day 14 if applicable
Plan to share: No
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Perrigo CSCI