Head LiceNCT00672971
Safety and Efficacy Study to Compare a 4% Dimethicone Foam and Nix Cream Rinse (1% Permethrin) in the Control of Head Lice
A study testing 4% dimethicone foam and 1% permethrin in people with Head Lice, run by Oystershell NV at 1 site in United States.
Trial summary
The purpose of this study was to evaluate the efficacy of a dimethicone foam in the control of head lice and to compare the efficacy to a permethrin based product. Read more about this study
- Who is it for?
- Ages 4 to 85 years
- Conditions the study is for
- Head Lice
- What is being tested?
- 4% dimethicone foam and 1% permethrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Nov 2007
- 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 4 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 4 - 85 years of age
- active head lice infestation of at least ≥ 10 live lice
- short hair (hair no longer than 2 inches below the neck) or long hair (hair 2 inches below the neck to mid back)
Who cannot join
- had received or used an investigational new drug within the 30 days immediately preceding the study
- used any form of head lice treatment whether prescription, over-the-counter, or a home remedy for at least fourteen days prior to their study visit
- used topical medication of any kind on the hair for a period of 48 hours prior to the visit
- had a history of allergy to rag weed, permethrin, or mineral oil, or had taken trimethoprim or cotrimoxazole at evaluation or during the previous four weeks
- Female subjects that were pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Randomized Study to Compare the Safety and Efficacy of Silcap Plus (Approximately 4% Dimeticone) Against Nix Cream Rinse.
The purpose of this study was to evaluate the efficacy of a dimethicone foam in the control of head lice and to compare the efficacy to a permethrin based product.
- Conditions
- Head Lice
- Being tested
- 4% dimethicone foam, 1% permethrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4% dimethicone foamOther
Also called Oxykal, Neo-paraderma
The dimethicone foam is applied to dry hair and left on the hair for approximately 15 minutes. The product is then removed by washing the hair with baby shampoo. The foam is applied two time, separated by an interval of 7-9 days.
1% permethrinOther
Also called Nix cream rinse
Nix® Cream Rinse is applied as indicated on the product labeling. The cream rinse is applied to wet hair and left on the hair for 10 minutes. The hair is then rinsed with tepid water to remove the product, toweled dry, and combed with a detangling comb. The product is applied two times, separated by an interval of 7-9 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 4% dimethicone foam Receives: Other: 4% dimethicone foam |
| 2 | Active comparator | 1% permethrin Receives: Other: 1% permethrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate at the final visit (Day 14 or 15). Cure rate was defined as the number of subjects free of live head lice divided by the total number of subjects in the treatment group (x 100).
Measured: 14 or 15 days after 1st treatment
Secondary outcomes (1)
Any adverse events during or after application of the product
Measured: up to 7 or 8 d after product application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startSep 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oystershell NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lidia Serrano, CRI, Principal investigator, Lice Source Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672971
- Sponsor's protocol ID
- OYS001-07
- Status last verified
- May 2008
- First submitted
- 2 May 2008
- Last updated
- 6 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Randomized Study to Compare the Safety and Efficacy of Silcap Plus (Approximately 4% Dimeticone) Against Nix Cream Rinse.
- ClinicalTrials.gov ID
- NCT00672971
- Acronym / sponsor ID
- OYS001-07
- Conditions
- Head Lice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Oystershell NVIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 6 May 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 purpose of this study was to evaluate the efficacy of a dimethicone foam in the control of head lice and to compare the efficacy to a permethrin based product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: 4% dimethicone foam4% dimethicone foam |
| 2 | Active comparator | Other: 1% permethrin1% permethrin |
Who may qualify
- Ages
- 4 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 4 - 85 years of age
- active head lice infestation of at least ≥ 10 live lice
- short hair (hair no longer than 2 inches below the neck) or long hair (hair 2 inches below the neck to mid back)
Key exclusion criteria (5 listed)
- had received or used an investigational new drug within the 30 days immediately preceding the study
- used any form of head lice treatment whether prescription, over-the-counter, or a home remedy for at least fourteen days prior to their study visit
- used topical medication of any kind on the hair for a period of 48 hours prior to the visit
- had a history of allergy to rag weed, permethrin, or mineral oil, or had taken trimethoprim or cotrimoxazole at evaluation or during the previous four weeks
- Female subjects that were pregnant or breast feeding
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 |
|---|---|---|
| 4% dimethicone foamAlso: Oxykal, Neo-paradermaThe dimethicone foam is applied to dry hair and left on the hair for approximately 15 minutes. The product is then removed by washing the hair with baby shampoo. The foam is applied two time, separated by an interval of 7-9 days. | Other | 1 |
| 1% permethrinAlso: Nix cream rinseNix® Cream Rinse is applied as indicated on the product labeling. The cream rinse is applied to wet hair and left on the hair for 10 minutes. The hair is then rinsed with tepid water to remove the product, toweled dry, and combed with a detangling comb. The product is applied two times, separated by an interval of 7-9 days. | Other | 2 |
Primary outcome
Cure rate at the final visit (Day 14 or 15). Cure rate was defined as the number of subjects free of live head lice divided by the total number of subjects in the treatment group (x 100).
Time frame: 14 or 15 days after 1st treatment
1 secondary outcome
Any adverse events during or after application of the product
Time frame: up to 7 or 8 d after product application
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 6 May 2008.
Related trials for Head Lice
Recruiting
Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).
Lice; Head Lice
Not yet recruiting
Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
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Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.
Lice; Head Lice
Recruiting
Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo
Head Lice
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, CRI 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 4% dimethicone foam and 1% permethrin 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 3 inclusion and 5 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 6 May 2008. 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?
Cure rate at the final visit (Day 14 or 15). Cure rate was defined as the number of subjects free of live head lice divided by the total number of subjects in the treatment group (x 100). (time frame: 14 or 15 days after 1st treatment). 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 6 May 2008.