Head LicePhase 1NCT00605956
NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers
A Phase 1 study testing NatrOVA Creme Rinse - 1% and Blank Patch in people with Head Lice, run by ParaPRO LLC at 1 site in United States.
Trial summary
Photoallergic reactions are assumed to be due to a delayed cell-mediated hypersensitivity response that requires the presence of ultraviolet irradiation. The predictive procedure is, therefore, based on modification of the Repeated Insult Patch Test (Kaidbey, 1991). 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?
- NatrOVA Creme Rinse - 1% and Blank Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Feb 2008
- 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
- Has the ability to understand and has signed a written informed consent form and HIPAA authorization
- Females of childbearing potential must agree to use an adequate birth control
- Fitzpatrick (1988) 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, medical tape, or ingredients found in the test articles
- Inability to evaluate the skin in and around the test sites
- Diabetes requiring medication
- Clinical significant skin diseases which may contraindicate participation
- Asthma or any other severe respiratory disease requiring chronic medication
Show all 20Show fewer
- Known immunological disorders such as HIV, AIDS, SLE and/or RA
- History, within the last six months, of current cancer, including skin cancer
- Mastectomy for cancer removal of lymph nodes draining test sites
- Epilepsy
- Pregnancy, lactation, or planning a pregnancy during the test period
- Chronic use of systemic antihistamine medication, or use within 14 days prior to Screening Visit
- Use of anti-inflammatory drugs (exception: acetaminophen and < 81 mg.day aspirin are permitted) within 2 days of Screening Visit
- Currently receiving allergy injections
- Currently taking or expecting to take any photosensitizing medications
- Use of immunosuppressive drugs
- Topical drugs used at the test sites within the last 7 days prior to screening
- Current participation in any clinical trial
- Participation in any patch test for irritation or sensitization or any test involving UV exposures within 4 wees of study start
- Use of any investigational therapy within the past 4 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Photoallergy Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers
Photoallergic reactions are assumed to be due to a delayed cell-mediated hypersensitivity response that requires the presence of ultraviolet irradiation. The predictive procedure is, therefore, based on modification of the Repeated Insult Patch Test (Kaidbey, 1991). Duplicate sets of patches of test articles are used with exposure of only one set to UV radiation and subsequent evaluation of both sets for skin reactions in order to compare irradiated versus non-irradiated test sites.
Read the detailed description
The study consists of of following phases: screening, induction, rest, challenge, and re-challenge (if necessary). The study will be conducted as a randomized, evaluator-blind test design.
- Conditions
- Head Lice
- Being tested
- NatrOVA Creme Rinse - 1%, NatrOVA Creme Rinse Vehicle Only, Blank Patch
- Keywords
- head lice, NatrOVA Creme Rinse - 1% is intended for the treatment of head lice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatrOVA Creme Rinse - 1%Drug
NatrOVA Creme Rinse - 1% spinosad
NatrOVA Creme Rinse Vehicle OnlyDrug
NatrOVA Creme Rinse Vehicle - no spinosad
Blank PatchDrug
Blank Patch
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | NatrOVA Creme Rinse - 1% Spinosad Receives: Drug: NatrOVA Creme Rinse - 1% |
| 2 | Experimental | NatrOVA Vehicle - no Spinosad Receives: Drug: NatrOVA Creme Rinse Vehicle Only |
| 3 | Placebo comparator | Blank Patch Receives: Drug: Blank Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual grading of test site and assessments of adverse experiences
Measured: Evaluations over a 6 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 2008
- Study completionFeb 2008
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 65 participants (estimated)
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
- NCT00605956
- Sponsor's protocol ID
- SPN-108-08
- Other IDs
- HTR Study #07-128385-111
- Status last verified
- May 2008
- First submitted
- 21 Jan 2008
- Last updated
- 4 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Photoallergy Potential of NatrOVA Creme Rinse - 1% in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00605956
- Acronym / sponsor ID
- SPN-108-08
- Conditions
- Head Lice
- Keywords
- head lice, NatrOVA Creme Rinse - 1% is intended for the treatment of head lice
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- ParaPRO LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 1 Feb 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.
Photoallergic reactions are assumed to be due to a delayed cell-mediated hypersensitivity response that requires the presence of ultraviolet irradiation. The predictive procedure is, therefore, based on modification of the Repeated Insult Patch Test (Kaidbey, 1991). Duplicate sets of patches of test articles are used with exposure of only one set to UV radiation and subsequent evaluation of both sets for skin reactions in order to compare irradiated versus non-irradiated test sites.
Detailed description
The study consists of of following phases: screening, induction, rest, challenge, and re-challenge (if necessary). The study will be conducted as a randomized, evaluator-blind test design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NatrOVA Creme Rinse - 1%NatrOVA Creme Rinse - 1% Spinosad |
| 2 | Experimental | Drug: NatrOVA Creme Rinse Vehicle OnlyNatrOVA Vehicle - no Spinosad |
| 3 | Placebo comparator | Drug: Blank PatchBlank Patch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects 18-65 years of age
- Has the ability to understand and has signed a written informed consent form and HIPAA authorization
- Females of childbearing potential must agree to use an adequate birth control
- Fitzpatrick (1988) skin type I, II, or III.
Key exclusion criteria (20 listed)
- History of severe reactions from exposure to sunlight
- Known allergies or sensitivities to adhesives in patches, medical tape, or ingredients found in the test articles
- Inability to evaluate the skin in and around the test sites
- Diabetes requiring medication
- Clinical significant skin diseases which may contraindicate participation
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 |
|---|---|---|
| NatrOVA Creme Rinse - 1%NatrOVA Creme Rinse - 1% spinosad | Drug | 1 |
| NatrOVA Creme Rinse Vehicle OnlyNatrOVA Creme Rinse Vehicle - no spinosad | Drug | 2 |
| Blank PatchBlank Patch | Drug | 3 |
Primary outcome
Visual grading of test site and assessments of adverse experiences
Time frame: Evaluations over a 6 week period
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 4 Aug 2008.
- sponsor websiteLink 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 NatrOVA Creme Rinse - 1% and Blank Patch 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 4 inclusion and 20 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 4 Aug 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?
Visual grading of test site and assessments of adverse experiences (time frame: Evaluations over a 6 week period). 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 4 Aug 2008.