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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05379114
Other study ID # 20E4084
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 18, 2022
Est. completion date September 2022

Study information

Verified date May 2022
Source Perrigo CSCI
Contact Céline Lhéritier
Phone +33 (0)6 71 32 33 20
Email clh@dermscan.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 136
Est. completion date September 2022
Est. primary completion date July 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years and older
Eligibility Inclusion Criteria: 1. Healthy subject; 2. Sex: male or female; 3. Age: 2 years and above; 4. Subject with a slight to moderate lice infestation 5. Subjects with various hair type (from 1 to 3C - hair scale) and hair length (from short to mid length hair, not exceeding shoulder) 6. Documented oral informed consent for all subjects, including minors, given freely and expressly before the start of the study 7. Written informed consent for subjects =18 years or legal guardian for subjects< 18 years given freely and expressly before start of the study; 8. Written assent for subjects =12 to <18 years. 9. Subject/Subject's legal guardian is psychologically able to understand the study related information and to give written informed consent; 10. Females of childbearing potential must have a negative pregnancy test before the beginning of the study Exclusion Criteria: In terms of population 1. Pregnant (confirmed by pregnancy test for women of childbearing potential) or nursing woman or planning a pregnancy during the study; 2. Subject who had been deprived of their freedom by administrative or legal decision or adult subject who is under guardianship; 3. Subject in a social or sanitary establishment; 4. 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. 5. Subject suspected to be non-compliant according to the Investigator's judgment. 6. Subject with curly or frizzy hair (type 4a to 4c in the hair type scale above) 7. Subject with hair length below the shoulder. 8. Subjects with more than 24 lice on the head In terms of associated pathology 9. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results. 10. Subject with a cutaneous disease on the studied zone (scalp and hair). 11. Subject with severe scratches or open wounds/skin damages on the scalp (lice bites allowed however). 12. 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. 13. Subject who has diabetes (type 1 or 2). 14. Subject with known or suspected immune deficiency or autoimmune disease. Relating to previous or ongoing treatment 15. 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. 16. Subject who received an anti-lice treatment in the previous 2 months.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
INVESTIGATIONAL DEVICE
new medical device for the treatment of head lice infestation: Paranix ®
Comparator device
well established medical device for the treatment of head lice infestation (dimethicone based) - Pouxit ®

Locations

Country Name City State
Mauritius Céline Lhéritier Quatre Bornes

Sponsors (1)

Lead Sponsor Collaborator
Perrigo CSCI

Country where clinical trial is conducted

Mauritius, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. day 7
Primary 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. day 14
Secondary 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. Day 7
Secondary 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 Day 0 and Day 7 if applicable
Secondary Live lice and nymphs, after application Evaluation of the presence of live lice and nymphs, for both groups, without combing on scalp Day 1 and Day 8 if applicable
Secondary Number of participants with treatment-related adverse events as assessed by investigator Evaluation of the safety and tolerability of the investigational device versus comparator Day 0, 7, 8 and 14 if applicable
Secondary 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
Day 7 or Day14
See also
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Completed NCT00858481 - A Pilot Dose Ranging Study of Spinosad Creme Rinse Phase 2
Completed NCT03301649 - Clinical Endpoint Study of Ivermectin 0.5% Lotion Phase 3
Completed NCT00994422 - Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects Phase 2
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Completed NCT03337490 - A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice Phase 3
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Completed NCT02213055 - Pediatric Head Lice Study Product Comparison Phase 2
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Completed NCT03617926 - A Clinical Trial to Evaluate Efficacy and Safety of a Water-soluble Head Lice Product. N/A
Completed NCT01803581 - A Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice N/A
Completed NCT01068158 - A Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects Phase 3
Completed NCT01066585 - A Safety and Efficacy Study Comparing 0.5% Ivermectin Cream to a Vehicle Control in Subjects With Head Lice Infestation Phase 3
Completed NCT00857935 - A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse Phase 2
Completed NCT00301340 - Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice Phase 3
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Completed NCT00605956 - NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers Phase 1
Completed NCT00479310 - Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice Phase 3