Randomized Medical Device Class IIa Clinical Investigation to Assess the Safety and Efficacy of a New Shampoo for Head Lice Treatment
Sponsor study identifier
interventional
180
1 country
1
Study Start
February 2026
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Primary Completion
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2026
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 18, 2025
Actual (reported)February 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 5, 2026
Actual (reported)May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
14 days
Cure rate after one dose of Investigational device (ID)
Day 7
Number of dead and live lice/nymphs after treatment
Day 0 and Day 7 if applicable
Number of live lice and nymphs, after application of treatment
Day 1 and Day 8 if applicable
Number of participants with treatment-related adverse events as assessed by investigator
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
Day 1 , Day 7 or Day 14 if applicable
New medical device shampoo for the treatment of head lice infestation, 2 min treatment time : Paranix ®
New medical device shampoo for the treatment of head lice infestation, 5 min treatment time : Paranix ®
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
CIDP
Phoenix, 73408, Mauritius
Gitanjali PETKAR, Dermatologist
First Submitted
September 18, 2025
First Posted
February 5, 2026
Study Start
February 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2026
Estimated (date passed)Head lice shampoo treatment (medical device class 1) already in market in europe: Pouxit ®
well established medical device shampoo for the treatment of head lice infestation - Pouxit ®
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 10, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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