Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides

October 23, 2009 updated by: Omega Pharma

Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides Acting Mechanically With Reference Product Acting Chemically (Prioderm)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 016
        • St. Thomas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject-male or female, child > 3 years and adult
  • Pediculosis of scalp, confirmed by the identification of minimum 5 live lice with a fine-tooth comb
  • Negative urine pregnancy test before inclusion for women of childbearing potential
  • Use of a contraceptive method by hormonal contraceptives or IUDs or tubal ligation or condoms for women of childbearing potential
  • Subject agreeing to participate in the study with written informed consent for participation
  • Written consent of both parents for the minor patients.

Exclusion Criteria:

  • Children under 3 years.
  • Woman pregnant or lactating or without contraception
  • Use of a pediculicide or lenticide treatment within 2 weeks before entry into the study
  • Subject with known hypersensitivity to any component of the tested products
  • Subject who participated in a clinical study in the 3 months prior to inclusion
  • Ongoing treatment potentially interacting with the treatment under study (other pediculicide products)
  • Subject undertreatment susceptible to influence the evaluation of the trial (including trimethoprim-sulfamethoxazole).
  • Severe medical or psychiatric illness considered by the investigator as potentially dangerous to the subject or incompatible with the conduct of the study
  • Asthma
  • Subject unable for linguistic or psychiatric reasons to understand the information and give informed consent
  • Subject refusing to give written consent
  • Subject deprived of his liberty by administrative or judicial decision, or guardianship
  • Patient hospitalized in a medical or social facility for another reason that biomedical research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
statistical analysis will compare the number of successes and failures for each products
Time Frame: Day 1, Day 7 and day 14
Day 1, Day 7 and day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Omega Pharma

Investigators

  • Principal Investigator: Claire Bouges-Michel, MD, MCU-¨H, Parasitology-Mycology, APHP, CHU Avicienne
  • Principal Investigator: Rexline, Dr. Sr., St. Thomas Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

September 24, 2008

First Submitted That Met QC Criteria

September 24, 2008

First Posted (ESTIMATE)

September 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 27, 2009

Last Update Submitted That Met QC Criteria

October 23, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OMEGA-IZ2008-V6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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