Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neem Lotion With Combing for Lice

NCT02974088

Pediculoses Head Lice

COMPLETED PHASE2

Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice

NCT00963508

Pediculosis

COMPLETED PHASE3

Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice

NCT00927407

Pediculosis

COMPLETED PHASE1

Phototoxicity Potential of NatrOVA Creme Rinse - 1%

NCT00591331

Head Lice

COMPLETED PHASE1

Clinical Endpoint Study of Ivermectin 0.5% Lotion

NCT03301649

Head Lice

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Headlice Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Paranix

pediculicide product

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Paranix Spray Paranix Mousse Paranix Lotion Hedrin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes