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Sponsored by: |
Omega Pharma |
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Information provided by: | Omega Pharma |
ClinicalTrials.gov Identifier: | NCT00758823 |
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.
Condition | Intervention |
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Headlice Infections |
Device: Paranix |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Single Group Assignment |
Official Title: | Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides Acting Mechanically With Reference Product Acting Chemically (Prioderm) |
Estimated Enrollment: | 750 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 3 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
India, Tamil Nadu | |
St. Thomas Hospital | |
Chennai, Tamil Nadu, India, 600 016 |
Principal Investigator: | Claire Bouges-Michel, MD, MCU-¨H | Parasitology-Mycology, APHP, CHU Avicienne |
Principal Investigator: | Rexline, Dr. Sr. | St. Thomas Hospital |
Responsible Party: | Omega Pharma ( Maureen Tytgat/Plant Manager ) |
Study ID Numbers: | OMEGA-IZ2008-V6 |
Study First Received: | September 24, 2008 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00758823 History of Changes |
Health Authority: | India: Ministry of Health |
head lice |
Lice Infestations Malathion |
Infection |