Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides

NCT00758823 | Completed DMC

• 1 other identifier: OMEGA-IZ2008-V6
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Headlice Infections

Keywords

head lice

Outcome Measures

Primary Outcomes (1)

• statistical analysis will compare the number of successes and failures for each products

  Day 1, Day 7 and day 14

Interventions

Paranix DEVICE

pediculicide product

Also known as: Paranix Spray, Paranix Mousse, Paranix Lotion, Hedrin

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Omega Pharma: lead

Study Sites (1)

St. Thomas Hospital

Chennai, Tamil Nadu, 600 016, India

Location

Study Officials

• Claire Bouges-Michel, MD, MCU-¨H

  Parasitology-Mycology, APHP, CHU Avicienne

  PRINCIPAL INVESTIGATOR

• Rexline, Dr. Sr.

  St. Thomas Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 27, 2009

Record last verified: 2009-10

Locations

IN (1)