Headlice InfectionsNCT00758823
Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides
A study testing Paranix in people with Headlice Infections, run by Omega Pharma at 1 site in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Headlice Infections
- What is being tested?
- Paranix
- Type of treatment
- Medical device
- How many people
- 750 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2008to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides Acting Mechanically With Reference Product Acting Chemically (Prioderm)
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.
- Conditions
- Headlice Infections
- Being tested
- Paranix
- Keywords
- head lice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParanixDevice
Also called Paranix Spray, Paranix Mousse, Paranix Lotion, Hedrin
pediculicide product
What is being measured
The primary outcome is the main question the study is designed to answer.
statistical analysis will compare the number of successes and failures for each products
Measured: Day 1, Day 7 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headlice InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omega Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Claire Bouges-Michel, MD, MCU-¨H, Principal investigator, Parasitology-Mycology, APHP, CHU AvicienneRexline, Dr. Sr., Principal investigator, St. Thomas Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758823
- Sponsor's protocol ID
- OMEGA-IZ2008-V6
- Status last verified
- Oct 2009
- First submitted
- 24 Sep 2008
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Efficacy and Tolerance of Four Pediculicides Acting Mechanically With Reference Product Acting Chemically (Prioderm)
- ClinicalTrials.gov ID
- NCT00758823
- Acronym / sponsor ID
- OMEGA-IZ2008-V6
- Conditions
- Headlice Infections
- Keywords
- head lice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Omega PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParanixAlso: Paranix Spray, Paranix Mousse, Paranix Lotion, Hedrinpediculicide product | Device | – |
Primary outcome
statistical analysis will compare the number of successes and failures for each products
Time frame: Day 1, Day 7 and day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Bouges-Michel, MD, MCU-¨H principal investigator
Parasitology-Mycology, APHP, CHU Avicienne
Rexline, Dr. Sr. principal investigator
St. Thomas Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paranix in people with Headlice Infections, run by Omega Pharma at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
statistical analysis will compare the number of successes and failures for each products (time frame: Day 1, Day 7 and day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2009.