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Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides

NCT00758823 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2009-10-27

No results posted yet for this study

Summary

THe main goal of our randomized controlled trial with blinded observer will be to compare four pediculicide products acting mechanically, Paranix Spray, Paranix Lotion, Paranix Mousse and Hedrin against a reference product acting chemically, Prioderm, during a non-inferiority (20% equivalence). THe randomization will be balanced every 10 families. The secondary objective will be to compare the lenticide efficacy of the products and their local tolerance and cosmetic acceptibility.

Conditions

  • Headlice Infections

Interventions

DEVICE

Paranix

pediculicide product

Sponsors & Collaborators

  • Omega Pharma

    lead INDUSTRY

Principal Investigators

  • Claire Bouges-Michel, MD, MCU-¨H · Parasitology-Mycology, APHP, CHU Avicienne

  • Rexline, Dr. Sr. · St. Thomas Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00758823 on ClinicalTrials.gov