Headlice Infections
Conditions
Keywords
head lice
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.
Interventions
DEVICEParanix
pediculicide product
Sponsors
Omega Pharma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| statistical analysis will compare the number of successes and failures for each products | Day 1, Day 7 and day 14 |
Countries
India
Outcome results
None listed