Head LiceNCT01803581
A Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice
A study testing X92001327 in people with Head Lice, run by Oystershell NV at 1 site in United States.
Trial summary
The purpose of this study is to compare the efficacy and safety of an insecticide-free head lice product with that of a pyrethrum-based product. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Head Lice
- What is being tested?
- X92001327
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2013to 12 Aug 2013
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female over the age of 1 at the time of signing the informed consent or giving assent
- Have an active head lice infestation of at least 5 live lice and 5 viable nits
- subject must be capable of understanding and providing written informed consent
- agree not to use any other pediculicides or medicated hair grooming products for the duration of the study
- agree not to use a lice comb during the study
- the parent or guardian of a child must be willing to have other family members screened for head lice.
- have a single place of residence
Who cannot join
- used any form of head lice treatment whether prescription or over the counter or home remedy at least four weeks prior to their screening visit
- used any topical medication of any kind for a period of 48 hours prior to the screening visit
- individuals on systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results
- has a history of allergy or hypersensitivity to ragweed, hydrocarbons, sesame oil, perfume or any ingredient in either test product
- individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel will interfere with the evaluation of the test product
- individuals who, in the opinion of the investigative personnel do not understand the subject requirements for study participation and/or may be likely to exhibit poor compliance with the required visits
Show all 9Show fewer
- females who are pregnant or nursing
- patients that have taken trimethoprim or a combination of sulfamethoxazole at evaluation or during the previous 4 weeks
- subjects with hair longer than mid back
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Investigator-blinded, Comparative Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice
The purpose of this study is to compare the efficacy and safety of an insecticide-free head lice product with that of a pyrethrum-based product.
Read the detailed description
The primary objective of the study was to compare the safety and efficacy of X92001327 versus RID in subjects with head lice. The subjects received a single application on Day 0 of either X92001327 or RID shampoo based on the randomization schedule. A repeat application of the test product was administered on Day 7. Subjects visited the clinic four times: on Day 0, Day 1, Day 7 and Day 10.
- Conditions
- Head Lice
- Being tested
- X92001327, RID shampoo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X92001327Other
RID shampooOther
| Study group | Role | What they receive |
|---|---|---|
| X92001327 | Experimental | the X92001327 product is a lotion to be applied on dry hair for 15 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7. Receives: Other: X92001327 |
| RID shampoo | Active comparator | The RID shampoo is to be applied on dry the hair for 10 minutes and then rinsed out with water. the product is to be applied on Day 0 and repeated again on Day 7. Receives: Other: RID shampoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects lice free at the end of the study (Day 10)
Primary objective of this study was the cure rate (%) in each treatment group, following two applications (day 0 and day 7) of the specific test product, as assessed on the last evaluation visit (day 10).
Measured: Day 10
Secondary outcomes (1)
The proportion of subjects lice free at each of the intermediate evaluations (Day 1, Day 7)
Secondary outcome involved the cure rate (%) in each treatment group, following one application of the specific test product, as assessed 24h post treatment (day 1) and on day 7 (prior to the second treatment).
Measured: Day 1, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study start5 Mar 2013
- Primary completion20 Jun 2013
- Study completion12 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head LiceStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oystershell NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lidia Serrano, Principal investigator, Lice Source Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803581
- Sponsor's protocol ID
- OYS004-0013
- Status last verified
- Nov 2013
- First submitted
- 12 Feb 2013
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Barker SC, Burgess I, Meinking TL, Mumcuoglu KY. International guidelines for clinical trials with pediculicides. Int J Dermatol. 2012 Jul;51(7):853-8. doi: 10.1111/j.1365-4632.2011.05446.x.
PubMed 22715834
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Investigator-blinded, Comparative Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice
- ClinicalTrials.gov ID
- NCT01803581
- Acronym / sponsor ID
- OYS004-0013
- Conditions
- Head Lice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Oystershell NVIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2013 (actual)
- Primary completion
- 20 Jun 2013 (actual)
- Study completion
- 12 Aug 2013 (actual)
- First posted
- 4 Mar 2013 (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 purpose of this study is to compare the efficacy and safety of an insecticide-free head lice product with that of a pyrethrum-based product.
Detailed description
The primary objective of the study was to compare the safety and efficacy of X92001327 versus RID in subjects with head lice. The subjects received a single application on Day 0 of either X92001327 or RID shampoo based on the randomization schedule. A repeat application of the test product was administered on Day 7. Subjects visited the clinic four times: on Day 0, Day 1, Day 7 and Day 10.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| X92001327 | Experimental | Other: X92001327the X92001327 product is a lotion to be applied on dry hair for 15 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7. |
| RID shampoo | Active comparator | Other: RID shampooThe RID shampoo is to be applied on dry the hair for 10 minutes and then rinsed out with water. the product is to be applied on Day 0 and repeated again on Day 7. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female over the age of 1 at the time of signing the informed consent or giving assent
- Have an active head lice infestation of at least 5 live lice and 5 viable nits
- subject must be capable of understanding and providing written informed consent
- agree not to use any other pediculicides or medicated hair grooming products for the duration of the study
- agree not to use a lice comb during the study
Key exclusion criteria (9 listed)
- used any form of head lice treatment whether prescription or over the counter or home remedy at least four weeks prior to their screening visit
- used any topical medication of any kind for a period of 48 hours prior to the screening visit
- individuals on systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results
- has a history of allergy or hypersensitivity to ragweed, hydrocarbons, sesame oil, perfume or any ingredient in either test product
- individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel will interfere with the evaluation of the test product
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 |
|---|---|---|
| X92001327 | Other | X92001327 |
| RID shampoo | Other | RID shampoo |
Primary outcome
The proportion of subjects lice free at the end of the study (Day 10)
Time frame: Day 10
Primary objective of this study was the cure rate (%) in each treatment group, following two applications (day 0 and day 7) of the specific test product, as assessed on the last evaluation visit (day 10).
1 secondary outcome
The proportion of subjects lice free at each of the intermediate evaluations (Day 1, Day 7)
Time frame: Day 1, Day 7
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 5 Apr 2018.
- Background: PubMed 22715834Barker SC, Burgess I, Meinking TL, Mumcuoglu KY. International guidelines for clinical trials with pediculicides. Int J Dermatol. 2012 Jul;51(7):853-8. doi: 10.1111/j.1365-4632.2011.05446.x.
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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.
Lidia Serrano principal investigator
Lice Source Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X92001327 in people with Head Lice, run by Oystershell NV at 1 site in United States.
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 7 inclusion and 9 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 5 Apr 2018. 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 United States. 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?
The proportion of subjects lice free at the end of the study (Day 10) (time frame: Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01803581, which also lists 1 linked publication.
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 5 Apr 2018.