Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides

Omega Pharma

Status

Completed

Conditions

Headlice Infections

Treatments

Device: Paranix

Study type

Interventional

Funder types

Industry

Identifiers

NCT00758823

OMEGA-IZ2008-V6

Details and patient eligibility

About

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.

Enrollment

750 estimated patients

Sex

All

Ages

3+ years old

Volunteers

Accepts Healthy Volunteers

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