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Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00758823
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : October 27, 2009
Information provided by:
Omega Pharma

Tracking Information
First Submitted Date  ICMJE September 24, 2008
First Posted Date  ICMJE September 25, 2008
Last Update Posted Date October 27, 2009
Study Start Date  ICMJE August 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2008)
statistical analysis will compare the number of successes and failures for each products [ Time Frame: Day 1, Day 7 and day 14 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00758823 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides
Official Title  ICMJE Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides Acting Mechanically With Reference Product Acting Chemically (Prioderm)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Headlice Infections
Intervention  ICMJE Device: Paranix
pediculicide product
Other Names:
  • Paranix Spray
  • Paranix Mousse
  • Paranix Lotion
  • Hedrin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 24, 2008)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00758823
Other Study ID Numbers  ICMJE OMEGA-IZ2008-V6
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maureen Tytgat/Plant Manager, Omega Pharma
Study Sponsor  ICMJE Omega Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claire Bouges-Michel, MD, MCU-¨H Parasitology-Mycology, APHP, CHU Avicienne
Principal Investigator: Rexline, Dr. Sr. St. Thomas Hospital
PRS Account Omega Pharma
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP