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Suffocating Agent

Test product for Head Lice

N/A
Recruiting
Led By Susel Gonzalez Acosta, ARNP
Research Sponsored by Oystershell NV
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0, day 1, day 7, day 10
Awards & highlights

Study Summary

The present study is set-up to compare in vivo clinical performance and safety of the test product (X92001752) versus 3 other pediculicides (2 medical devices and 1 conventional pesticide).

Eligible Conditions
  • Head Lice

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, day 1, day 7, day 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, day 1, day 7, day 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Including All Baseline Infestations).
Secondary outcome measures
Assessment of Adverse Events Occurring After 1 and/or 2 Treatments With Both Investigational Products.
Effect of All Investigational Treatments on Eye Irritation, as Assessed by a Blinded Clinical Investigator.
Effect of All Investigational Treatments on Paraesthesia (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Test productExperimental Treatment1 Intervention
Hemisqualane & beeswax-based lotion (X92001752), killing lice and nits via suffocation.
Group II: RID Super Max SolutionActive Control1 Intervention
Oligodecene oil-based lotion, killing lice and nits via suffocation.
Group III: Nix CrèmeActive Control1 Intervention
Conventional pesticide, containing 1% permethrin.
Group IV: Pouxit VégétalActive Control1 Intervention
Fatty acid salt-based lotion, killing lice and nits via suffocation.

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Who is running the clinical trial?

Oystershell NVLead Sponsor
12 Previous Clinical Trials
973 Total Patients Enrolled
Susel Gonzalez Acosta, ARNPPrincipal InvestigatorPI

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial to Evaluate Efficacy and Safety of a New Suffocating Head Lice Product.
2022. "A Clinical Trial to Evaluate Efficacy and Safety of a New Suffocating Head Lice Product.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05378477.
~68 spots leftby Apr 2025
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