Head LicePhase 1NCT00591331
Phototoxicity Potential of NatrOVA Creme Rinse - 1%
A Phase 1 study testing Spinosad (the active ingredient in NatrOVA) in people with Head Lice, run by ParaPRO LLC at 1 site in United States.
Trial summary
This study will evaluate the primary irritation potential of NatrOVA Creme Rinse - 1% in humans, after exposure to UV radiation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Head Lice
- What is being tested?
- Spinosad (the active ingredient in NatrOVA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2007
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects 18-65 years of age and in good health.
- Fitzpatrick skin type I, II or III
Who cannot join
- History of severe reactions from exposure to sunlight
- Known allergies or sensitivities to adhesives in patches
- Inability to evaluate the skin in and around the test sites
- Diabetes requiring medication
- Clinical significant skin disease
- Asthma or other severe respiratory disease
Show all 19Show fewer
- Known immunological disorders such as HIV, AIDS, lupus,rheumatoid arthritis
- History or current skin cancer
- Mastectomy for cancer involving removal of lymph nodes draining the test sites
- Epilepsy
- Pregnancy, lactation, or planned pregnancy during study period
- Chronic use of systemic antihistamine medication within 14 days of screening
- Use of anti-inflammatory drugs within 2 days of Screening Visit 1
- Currently receiving allergy injections
- Use of immunosuppressive drugs
- Topical drugs used at the test site within 7 days of Screening Visit 1
- Current participation in any clinical trial
- Participation in any patch test for irritation or sensitization or UV exposures within 4 weeks of study start
- Use of any investigational drug therapy within 4 weeks of study start.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Evaluation of the Phototoxic Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers
This study will evaluate the primary irritation potential of NatrOVA Creme Rinse - 1% in humans, after exposure to UV radiation.
- Conditions
- Head Lice
- Being tested
- Spinosad (the active ingredient in NatrOVA), placebo
- Keywords
- Head Lice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinosad (the active ingredient in NatrOVA)Drug
This is a patch test in which the test material is applied to the patch and the patch applied to the skin.
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | NatrOVA Creme Rinse - 1% Receives: Drug: Spinosad (the active ingredient in NatrOVA) |
| 2 | Experimental | NatrOVA Creme Rinse Vehicle Only Receives: Drug: Spinosad (the active ingredient in NatrOVA) |
| 3 | Placebo comparator | Blank patch Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoint will be visual grading of UV irradiated test sites and assessments of adverse experiences
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2007
- Study completionDec 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- ParaPRO LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John V Murray, MD, Principal investigator, Hill Top Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591331
- Sponsor's protocol ID
- SPN-107-07
- Other IDs
- HTR 07-128384-111
- Status last verified
- Dec 2007
- First submitted
- 28 Dec 2007
- Last updated
- 20 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Evaluation of the Phototoxic Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00591331
- Acronym / sponsor ID
- SPN-107-07
- Conditions
- Head Lice
- Keywords
- Head Lice
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- ParaPRO LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Jan 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.
This study will evaluate the primary irritation potential of NatrOVA Creme Rinse - 1% in humans, after exposure to UV radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Spinosad (the active ingredient in NatrOVA)NatrOVA Creme Rinse - 1% |
| 2 | Experimental | Drug: Spinosad (the active ingredient in NatrOVA)NatrOVA Creme Rinse Vehicle Only |
| 3 | Placebo comparator | Drug: placeboBlank patch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female subjects 18-65 years of age and in good health.
- Fitzpatrick skin type I, II or III
Key exclusion criteria (19 listed)
- History of severe reactions from exposure to sunlight
- Known allergies or sensitivities to adhesives in patches
- Inability to evaluate the skin in and around the test sites
- Diabetes requiring medication
- Clinical significant skin disease
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 |
|---|---|---|
| Spinosad (the active ingredient in NatrOVA)This is a patch test in which the test material is applied to the patch and the patch applied to the skin. | Drug | 1, 2 |
| placebo | Drug | 3 |
Primary outcome
Safety endpoint will be visual grading of UV irradiated test sites and assessments of adverse experiences
Time frame: 7 days
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 20 May 2008.
- sponsor web siteLink provided by the sponsor.
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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.
John V Murray, MD principal investigator
Hill Top Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Spinosad (the active ingredient in NatrOVA) in people with Head Lice, run by ParaPRO LLC 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 2 inclusion and 19 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 20 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety endpoint will be visual grading of UV irradiated test sites and assessments of adverse experiences (time frame: 7 days). 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 20 May 2008.