Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides
This study has been completed.
Sponsor:
Omega Pharma
Information provided by:
Omega Pharma
ClinicalTrials.gov Identifier:
NCT00758823
First received: September 24, 2008
Last updated: October 23, 2009
Last verified: October 2009
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Purpose
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 |
|---|---|
|
Headlice Infections |
Device: Paranix |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides Acting Mechanically With Reference Product Acting Chemically (Prioderm) |
Further study details as provided by Omega Pharma:
Primary Outcome Measures:
- statistical analysis will compare the number of successes and failures for each products [ Time Frame: Day 1, Day 7 and day 14 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 750 |
| Study Start Date: | August 2008 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Device: Paranix
- Paranix Spray
- Paranix Mousse
- Paranix Lotion
- Hedrin
pediculicide product
Other Names:
Eligibility| Ages Eligible for Study: | 3 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758823
Locations
| India | |
| St. Thomas Hospital | |
| Chennai, Tamil Nadu, India, 600 016 | |
Sponsors and Collaborators
Omega Pharma
Investigators
| Principal Investigator: | Claire Bouges-Michel, MD, MCU-¨H | Parasitology-Mycology, APHP, CHU Avicienne |
| Principal Investigator: | Rexline, Dr. Sr. | St. Thomas Hospital |
More Information
No publications provided
| Responsible Party: | Maureen Tytgat/Plant Manager, Omega Pharma |
| ClinicalTrials.gov Identifier: | NCT00758823 History of Changes |
| Other Study ID Numbers: | OMEGA-IZ2008-V6 |
| Study First Received: | September 24, 2008 |
| Last Updated: | October 23, 2009 |
| Health Authority: | India: Ministry of Health |
Keywords provided by Omega Pharma:
|
head lice |
ClinicalTrials.gov processed this record on June 17, 2013