Clinical trial NCT00758823: Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides
Official title: Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides Acting Mechanically With Reference Product Acting Chemically (Prioderm)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headlice Infections
Keywords: head lice
Lead sponsor: Omega Pharma
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 750
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: statistical analysis will compare the number of successes and failures for each products
timeFrame: Day 1, Day 7 and day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai
country: India
facility: St. Thomas Hospital
state: Tamil Nadu
Study officials:
affiliation: Parasitology-Mycology, APHP, CHU Avicienne
name: Claire Bouges-Michel, MD, MCU-¨H
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Thomas Hospital
name: Rexline, Dr. Sr.
role: PRINCIPAL_INVESTIGATOR
References: