Head LiceNCT03617926
A Clinical Trial to Evaluate Efficacy and Safety of a Water-soluble Head Lice Product.
A study testing X92001666 in people with Head Lice and Pediculosis Capitis, run by Oystershell NV at 2 sites in United States.
Trial summary
The present study is set-up to compare in vivo clinical performance and safety of the test product versus an in the US commercially available, pyrethrum-based product (RID® shampoo). Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head Lice, Pediculosis Capitis
- What is being tested?
- X92001666
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Mar 2018to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gender: male / female.
- Women of childbearing potential is a premenopausal female that is anatomically and physiologically capable of becoming pregnant following menarche.
- Female subjects: are women of childbearing potential who test negative for pregnancy and agree to use a reliable method of birth control or remain abstinent during the study. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring, diaphragm with contraceptive gel, or condom with contraceptive gel
- or are women of non-childbearing potential, defined as: women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation),
- or women who are ≥60 years of age.
- Age: ≥ 2 year of age at the time of enrollment.
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- Subject must have an active head lice infestation defined as at least 5 live lice (adults and/or nymphs) and 5 apparently live nits, present on the scalp and/or hair, as determined by a trained evaluator.
- Subject is in good general health based on medical history.
- The subject or his/her parent/legal guardian must give written informed consent, after having been oral and written informed about benefits and potential risks of the trial, as well as information regarding the insurance, taken out to cover the subjects participating in the study. A caregiver must sign an informed consent agreement for children not old enough to do so. Children ages 6-18 years of age will be administered a child's assent form. Subject or his/her parent/legal guardian must be capable of understanding and providing written informed consent.
- Following application and rinsing of the test products, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24-hour post treatment evaluation has been completed.
- The subject agrees not to cut or chemically treat their hair while participating in the study.
- No more than one working male per household may be excluded from evaluation if he is assessed as being lice free by himself or caregiver.
- Subject agrees to follow all study instructions, including attending all follow-up appointments.
- Agree to not use any other pediculicides or medicated hair grooming products for the duration of the study (through Day 10 visit).
- The parent or legal guardian of a child must be willing to have other family members screened for head lice. If other household members are found to have head lice and are eligible, they must be either enrolled in the study OR receive the standard of care at the site and in the same manner as study participants.
- Have a single place of residence.
- The subject or his/her parent or legal guardian must give written informed consent, after having been oral and written informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study
- Subjects must agree to not use any other ant-lice treatment for the duration of the study
Who cannot join
- Application of any form of head lice treatment, whether prescription or over-the-counter (OTC), or home remedy for 30 days prior to their screening visit (Day 1).
- Application of any topical medication of any kind on the hair for a period of 48 hours prior to the screening visit.
- Use of systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results.
- Known skin allergies, multiple drug allergies or multiple allergies to cosmetic products.
- History of allergy or hypersensitivity to ragweed, active ingredients or constituents of the test products.
- Subject 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.
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- Subjects with chronic scalp disorder.
- Subject or his/her legal guardian who, in the opinion of the investigative personnel, do not understand the subject requirements for study participations and/or may be likely to exhibit poor compliance with the required visits.
- Females who are pregnant or nursing.
- Hair longer than mid-back.
- Subject suspected or known not to follow instructions
- Previous participation in this study or participation in any other investigational trial within the preceding 30 days
- The subject is directly affiliated to the investigator site personnel and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- The subject is an Oystershell employee or is an employee of a third-party organizations involved in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
South Fla. Family Health & Research Ctr.LLC
Miami, Florida, 33186
Lice Source Services, Inc.
Plantation, Florida, 33313
About this study
Official title: A Randomized, Controlled, Investigator-Assessor Blinded, Comparative Study to Evaluate the Safety and Efficacy of a Water-Soluble Head Lice Suffocation Product (X92001666) vs RID Shampoo (Pyrethrin) in Subjects With Head Lice
The present study is set-up to compare in vivo clinical performance and safety of the test product versus an in the US commercially available, pyrethrum-based product (RID® shampoo).
Read the detailed description
The present study is set-up to compare in vivo clinical performance and safety of the test product versus an in the US commercially available, pyrethrum-based product (RID® shampoo). The study will be performed in subjects ≥2 year of both genders with confirmed diagnosis of head lice infestation. To support safety, local and global tolerability, skin and ocular irritation will be assessed and adverse events (AEs) will be registered.
- Conditions
- Head Lice, Pediculosis Capitis
- Being tested
- X92001666, RID shampoo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X92001666Device
Also called Test product
the X92001666 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 shampooOther
Also called Reference
Active Comparator: RID shampoo 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.
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Water-based lotion (internal code (X92001666) Receives: Device: X92001666 |
| Reference | Active comparator | Commercial, pyrethrin-based shampoo (RID shampoo) Receives: Other: RID shampoo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Including All Baseline Infestations).
Clinical efficacy is reflected by the % of subjects that are lice-free after 2 topical applications (at day 0 \& day 7 respectively) of the test product. In this analysis, all baseline infestations (mild, moderate, severe) have been included. Assessment is performed at study end (visit 4, day 10).
A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs
Measured: Day10
Secondary outcomes (12)
Number of Subjects That Are Lice-free After 2 Treatments With Reference Product (Including All Baseline Infestations).
Clinical efficacy is reflected by the % of subjects that are lice-free after 2 topical applications (at day 0 \& day 7 respectively) of the reference product. In this analysis, all baseline infestations (mild, moderate, severe) have been included. Assessment is performed at study end (visit 4, day 10).
A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs
Measured: Day 10
Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Only Mild and Moderate Baseline Infestations).
The % of subjects with a mild (5-9 lice and/or nymphs) and moderate (10-24 lice and/or nymphs) baseline infestation that are lice-free after two topical treatments (day 0 \& day 7) with the test product; assessed at study end (visit 4; day 10).
Measured: Day 10
Number of Subjects That Are Lice-free After 2 Treatments With Reference Product (Only Mild and Moderate Baseline Infestations).
The % of subjects with a mild (5-9 lice and/or nymphs) and moderate (10-24 lice and/or nymphs) baseline infestation that are lice-free after two topical treatments (day 0 \& day 7) with the reference product; assessed at study end (visit 4; day 10).
Measured: Day 10
Number of Subjects That Are Lice-Free After 1 Treatment With Test Product (All Baseline Infestations).
The % of subjects that are lice-free after one topical treatment with the test product (assessment 24h post treatment), considering all baseline infestations (mild, moderate, severe).
A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs
Measured: Day 1
Number of Subjects That Are Lice-free After 1 Treatment With Reference Product (All Baseline Infestations).
The % of subjects that are lice-free after one topical treatment with the reference product (assessment 24h post treatment), considering all baseline infestations (mild, moderate, severe).
A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs
Measured: Day 1
Effect of Both Investigational Treatments on Pruritus (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
The occurrence and degree of pruritus is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome).
None: the scalp does not itch; Mild: occasional episodes of itching, not bothersome; Moderate: frequent, several times a day, bothersome; Severe: nearly constant, frequent scratching, very bothersome.
Measured: Day 0, Day 1, Day 7, Day10
Effect of Both Investigational Treatments on Scalp Excoriation (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
The occurrence and degree of scalp excoriation (breaking of the skin, usually caused by scratching) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome).
None: no broken skin on the scalp; Mild: one or two areas on the scalp on which skin is broken; Moderate: more than two separate areas of the scalp with broken skin but not generalized across the scalp; Severe: widespread breaking of the skin involving most of the scalp.
Measured: Day 0, Day 1, Day 7, Day10
Effect of Both Investigational Treatments on Paraesthesia (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
The occurrence and degree of paraesthesia (tingling or prickling sensation) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome).
None: no tingling or prickling sensation; Mild: occasional tingling or prickling sensation; Moderate: frequent tingling or prickling sensation; Severe: nearly constant tingling or prickling sensation
Measured: Day 0, Day 1, Day 7, Day10
Effect of Both Investigational Treatments on Skin Erythema (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
The occurrence and degree of skin erythema (redness of the scalp) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome).
None: no redness of the scalp; Mild: faint, barely perceptible erythema with limited distribution; Moderate: diffuse pink areas of scalp are readily visible; Severe: large areas of the scalp are red.
Measured: Day 0, Day 1, Day 7, Day10
Effect of Both Investigational Treatments on Pyroderma (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
The occurrence and degree of pyroderma (sores filled with clear fluid, pus or crusting) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome).
None: no lesions visible on the scalp; Mild: one or two lesions visible with crusting or other evidence of infection; Moderate: presence of more than two lesions with crusting or other evidence of infection, but not generalized across the scalp; Severe: lesions with crusting or other evidence of infection, involving most of the scalp.
Measured: Day 0, Day 1, Day 7, Day10
Effect of Both Investigational Treatments on Eye Irritation, as Assessed by a Blinded Clinical Investigator.
The occurrence and degree of eye irritation (stinging, burning sensation, and/or pain) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome).
None: no stinging, burning or pain Mild: slight mild stinging, burning or pain Moderate: moderate stinging, burning or pain Severe: severe stinging, burning or pain
Measured: Day 0, Day 1, Day 7, Day10
Global Tolerability, Evaluated at Study End (Visit 4, Day 10)
Global tolerability is defined as the general well-being and comfort of the subjects. This parameter is assessed at day 10 in subjects, treated with either test product or reference product, respectively. The subject is asked to score his general feeling at study end and must provide a justification for his/her answer. Scoring was performed as follows: very good (best case), good, moderate, or poor (worst case).
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start7 Mar 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oystershell NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Rivera, CPI, Principal investigator, Study PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617926
- Sponsor's protocol ID
- OYS007-0017
- Status last verified
- Jun 2022
- First submitted
- 23 Jul 2018
- Last updated
- 5 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Eertmans F, Rossel B, Serrano L, Rivera E, Adriaens E. Efficacy and Safety of a Water-Based Head Lice Lotion: A Randomized, Controlled, Investigator-Blinded, Comparative, Bicentric Study. Dermatol Ther (Heidelb). 2019 Mar;9(1):143-157. doi: 10.1007/s13555-018-0274-x. Epub 2018 Nov 30.
PubMed 30506361
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Investigator-Assessor Blinded, Comparative Study to Evaluate the Safety and Efficacy of a Water-Soluble Head Lice Suffocation Product (X92001666) vs RID Shampoo (Pyrethrin) in Subjects With Head Lice
- ClinicalTrials.gov ID
- NCT03617926
- Acronym / sponsor ID
- OYS007-0017
- Conditions
- Head Lice, Pediculosis Capitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Oystershell NVIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 7 Aug 2018 (actual)
- Results
- Posted 7 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is set-up to compare in vivo clinical performance and safety of the test product versus an in the US commercially available, pyrethrum-based product (RID® shampoo).
Detailed description
The present study is set-up to compare in vivo clinical performance and safety of the test product versus an in the US commercially available, pyrethrum-based product (RID® shampoo). The study will be performed in subjects ≥2 year of both genders with confirmed diagnosis of head lice infestation. To support safety, local and global tolerability, skin and ocular irritation will be assessed and adverse events (AEs) will be registered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Device: X92001666Water-based lotion (internal code (X92001666) |
| Reference | Active comparator | Other: RID shampooCommercial, pyrethrin-based shampoo (RID shampoo) |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Gender: male / female.
- Women of childbearing potential is a premenopausal female that is anatomically and physiologically capable of becoming pregnant following menarche.
- Female subjects: are women of childbearing potential who test negative for pregnancy and agree to use a reliable method of birth control or remain abstinent during the study. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring, diaphragm with contraceptive gel, or condom with contraceptive gel
- Age: ≥ 2 year of age at the time of enrollment.
- Subject must have an active head lice infestation defined as at least 5 live lice (adults and/or nymphs) and 5 apparently live nits, present on the scalp and/or hair, as determined by a trained evaluator.
Key exclusion criteria (14 listed)
- Application of any form of head lice treatment, whether prescription or over-the-counter (OTC), or home remedy for 30 days prior to their screening visit (Day 1).
- Application of any topical medication of any kind on the hair for a period of 48 hours prior to the screening visit.
- Use of systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results.
- Known skin allergies, multiple drug allergies or multiple allergies to cosmetic products.
- History of allergy or hypersensitivity to ragweed, active ingredients or constituents of the test products.
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 |
|---|---|---|
| X92001666Also: Test productthe X92001666 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. | Device | Test product |
| RID shampooAlso: ReferenceActive Comparator: RID shampoo 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. | Other | Reference |
Primary outcome
Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Including All Baseline Infestations).
Time frame: Day10
Clinical efficacy is reflected by the % of subjects that are lice-free after 2 topical applications (at day 0 \& day 7 respectively) of the test product. In this analysis, all baseline infestations (mild, moderate, severe) have been included. Assessment is performed at study end (visit 4, day 10). A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs
12 secondary outcomes
Number of Subjects That Are Lice-free After 2 Treatments With Reference Product (Including All Baseline Infestations).
Time frame: Day 10
Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Only Mild and Moderate Baseline Infestations).
Time frame: Day 10
Number of Subjects That Are Lice-free After 2 Treatments With Reference Product (Only Mild and Moderate Baseline Infestations).
Time frame: Day 10
Number of Subjects That Are Lice-Free After 1 Treatment With Test Product (All Baseline Infestations).
Time frame: Day 1
Number of Subjects That Are Lice-free After 1 Treatment With Reference Product (All Baseline Infestations).
Time frame: Day 1
Effect of Both Investigational Treatments on Pruritus (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
Time frame: Day 0, Day 1, Day 7, Day10
Effect of Both Investigational Treatments on Scalp Excoriation (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
Time frame: Day 0, Day 1, Day 7, Day10
Effect of Both Investigational Treatments on Paraesthesia (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
Time frame: Day 0, Day 1, Day 7, Day10
Effect of Both Investigational Treatments on Skin Erythema (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
Time frame: Day 0, Day 1, Day 7, Day10
Effect of Both Investigational Treatments on Pyroderma (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
Time frame: Day 0, Day 1, Day 7, Day10
Effect of Both Investigational Treatments on Eye Irritation, as Assessed by a Blinded Clinical Investigator.
Time frame: Day 0, Day 1, Day 7, Day10
Global Tolerability, Evaluated at Study End (Visit 4, Day 10)
Time frame: Day 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30506361Eertmans F, Rossel B, Serrano L, Rivera E, Adriaens E. Efficacy and Safety of a Water-Based Head Lice Lotion: A Randomized, Controlled, Investigator-Blinded, Comparative, Bicentric Study. Dermatol Ther (Heidelb). 2019 Mar;9(1):143-157. doi: 10.1007/s13555-018-0274-x. Epub 2018 Nov 30.
- Individual participant dataSharing planned: No
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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.
Elisabeth Rivera, CPI principal investigator
Study PI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X92001666 in people with Head Lice and Pediculosis Capitis, run by Oystershell NV at 2 sites 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 18 inclusion and 14 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 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 7 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Including All Baseline Infestations). (time frame: Day10). 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 NCT03617926, 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 Jul 2022.