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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 24, 2008

Last Updated Date

October 23, 2009

Start Date ^ICMJE

August 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00758823 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

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

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Headlice Infections

Intervention ^ICMJE

Device: Paranix

pediculicide product

Other Names:

Paranix Spray
Paranix Mousse
Paranix Lotion
Hedrin

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

750

Completion Date

September 2008

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

Gender

Both

Ages

3 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

India

Administrative Information

NCT Number ^ICMJE

NCT00758823

Other Study ID Numbers ^ICMJE

OMEGA-IZ2008-V6

Has Data Monitoring Committee

Yes

Responsible Party

Maureen Tytgat/Plant Manager, Omega Pharma

Study Sponsor ^ICMJE

Omega Pharma

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Omega Pharma

Verification Date

October 2009

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

To Top