Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides

This study has been completed.
Sponsor:
Information provided by:
Omega Pharma
ClinicalTrials.gov Identifier:
NCT00758823
First received: September 24, 2008
Last updated: October 23, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention
Headlice Infections
Device: Paranix

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides Acting Mechanically With Reference Product Acting Chemically (Prioderm)

Further study details as provided by Omega Pharma:

Primary Outcome Measures:
  • statistical analysis will compare the number of successes and failures for each products [ Time Frame: Day 1, Day 7 and day 14 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 750
Study Start Date: August 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Paranix
    pediculicide product
    Other Names:
    • Paranix Spray
    • Paranix Mousse
    • Paranix Lotion
    • Hedrin
  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758823

Locations
India
St. Thomas Hospital
Chennai, Tamil Nadu, India, 600 016
Sponsors and Collaborators
Omega Pharma
Investigators
Principal Investigator: Claire Bouges-Michel, MD, MCU-¨H Parasitology-Mycology, APHP, CHU Avicienne
Principal Investigator: Rexline, Dr. Sr. St. Thomas Hospital
  More Information

No publications provided

Responsible Party: Maureen Tytgat/Plant Manager, Omega Pharma
ClinicalTrials.gov Identifier: NCT00758823     History of Changes
Other Study ID Numbers: OMEGA-IZ2008-V6
Study First Received: September 24, 2008
Last Updated: October 23, 2009
Health Authority: India: Ministry of Health

Keywords provided by Omega Pharma:
head lice

ClinicalTrials.gov processed this record on April 17, 2014