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OpenTrials
Completed

NCT Number: NCT00758823

Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides

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.

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Key information

Conditions

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Thomas Hospital

Chennai, Tamil Nadu, 600 016, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paranix

Device

pediculicide product

Other names: Paranix Spray, Paranix Mousse, Paranix Lotion, Hedrin

Primary outcomes

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

    Time frame: Day 1, Day 7 and day 14

Sponsors and collaborators

Lead sponsor

Omega Pharma

Industry

Registry information

Official study title

Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides Acting Mechanically With Reference Product Acting Chemically (Prioderm)

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 25, 2008
Registry last updated
Oct 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.