Randomized Controlled Trial Comparing Efficacy and Tolera... | NCT00758823

Studies
Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides

NCT00758823

Sponsor

Omega Pharma

Status

Completed

Last Update Posted

Oct 27, 2009Estimated

Enrollment

750Estimated

Phase

Not Applicable

Conditions

Headlice Infections

Interventions

Paranix

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Sep 24, 2008

First Submission Date that Met QC Criteria

Sep 24, 2008

First Posted Date

Sep 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2009

Last Update Posted Date

Oct 27, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

750Estimated

Name	Type	Description	Arm Group Labels	Other Names
Paranix	Device	pediculicide product		Paranix Spray Paranix Mousse Paranix Lotion Hedrin

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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