Pediculosis CapitisPhase 2NCT00858481
A Pilot Dose Ranging Study of Spinosad Creme Rinse
A Phase 2 study testing Spinosad Creme Rinse in people with Pediculosis Capitis and Head Lice, run by ParaPRO LLC at 1 site in United States.
Trial summary
A pilot dose ranging study to evaluate the safety and efficacy of different strengths of Spinosad Creme versus a vehicle control. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediculosis Capitis, Head Lice
- What is being tested?
- Spinosad Creme Rinse
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Nov 2005
- Phase
- Phase 2
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Active head lice infestation
- Male or female, 2 years of age or older
- Good general health
- Appropriately signed Informed Consent
- Subject agreement to not use any other form of lice treatment during the course of the study
- Subject agreement to not cut or chemically treat their hair between visits
Who cannot join
- History of irritation or sensitivity to pediculicides or hair care products
- Individuals with any visible skin/scalp condition that would interfere with the evaluation
- Individuals previously treated with a pediculicide within 4 weeks prior to study enrollment
- Individuals using hair dyes, bleaches, permanent waves or relaxing solutions 2 weeks prior to study enrollment
- Individuals who have participated in any clinical trial within 30 days of enrollment
- Individuals with family members who were infested with lice but were unwilling or unable to enroll in the study or use a standard course of lice treatment
- Females who were pregnant or nursing
- Sexually active females not using effective contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Different Strengths of Spinosad Topical Creme (0%, 0.5%, 1.0% or 2%) in Subjects With Pediculosis Capitis - a Dose Ranging Study
A pilot dose ranging study to evaluate the safety and efficacy of different strengths of Spinosad Creme versus a vehicle control.
Read the detailed description
A Phase 2a, randomized, single investigational site, investigator/evaluator-blind, four-arm, parallel-group, vehicle-controlled, pilot study to evaluate the safety and efficacy of different strengths of Spinosad Creme rinse verses vehicle control.
- Conditions
- Pediculosis Capitis, Head Lice
- Being tested
- Spinosad Creme Rinse - Vehicle Control, Spinosad Creme Rinse
- Keywords
- Pediculosis capitis, Head Lice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinosad Creme Rinse - Vehicle ControlDrug
One or two, 10-minute topical applications (7 days apart)
Spinosad Creme RinseDrug
0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
Spinosad Creme RinseDrug
1.0% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
Spinosad Creme RinseDrug
2.0% Spinosad Creme Rinse - one or two, 10-minute topical applications (7 days apart)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Vehicle control Receives: Drug: Spinosad Creme Rinse - Vehicle Control |
| 2 | Active comparator | 0.5% Spinosad creme rinse Receives: Drug: Spinosad Creme Rinse |
| 3 | Active comparator | 1.0% Spinosad Creme Rinse Receives: Drug: Spinosad Creme Rinse |
| 4 | Active comparator | 2.0% Spinosad Creme Rinse Receives: Drug: Spinosad Creme Rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of various doses of Spinosad, based on the presence or absence of live lice at 7 and 14 days post-treatment. The efficacy evaluation was performed by a trained evaluator.
Measured: 14 days
Secondary outcomes (1)
Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startSep 2005
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediculosis CapitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- ParaPRO LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dyal Garg, Ph.D., Principal investigator, Hill Top Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858481
- Sponsor's protocol ID
- SPN-201-05
- Other IDs
- HTR-124235
- Status last verified
- Oct 2015
- First submitted
- 5 Mar 2009
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Different Strengths of Spinosad Topical Creme (0%, 0.5%, 1.0% or 2%) in Subjects With Pediculosis Capitis - a Dose Ranging Study
- ClinicalTrials.gov ID
- NCT00858481
- Acronym / sponsor ID
- SPN-201-05
- Conditions
- Pediculosis Capitis, Head Lice
- Keywords
- Pediculosis capitis, Head Lice
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ParaPRO LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 9 Mar 2009 (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.
A pilot dose ranging study to evaluate the safety and efficacy of different strengths of Spinosad Creme versus a vehicle control.
Detailed description
A Phase 2a, randomized, single investigational site, investigator/evaluator-blind, four-arm, parallel-group, vehicle-controlled, pilot study to evaluate the safety and efficacy of different strengths of Spinosad Creme rinse verses vehicle control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Spinosad Creme Rinse - Vehicle ControlVehicle control |
| 2 | Active comparator | Drug: Spinosad Creme Rinse0.5% Spinosad creme rinse |
| 3 | Active comparator | Drug: Spinosad Creme Rinse1.0% Spinosad Creme Rinse |
| 4 | Active comparator | Drug: Spinosad Creme Rinse2.0% Spinosad Creme Rinse |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Active head lice infestation
- Male or female, 2 years of age or older
- Good general health
- Appropriately signed Informed Consent
- Subject agreement to not use any other form of lice treatment during the course of the study
Key exclusion criteria (8 listed)
- History of irritation or sensitivity to pediculicides or hair care products
- Individuals with any visible skin/scalp condition that would interfere with the evaluation
- Individuals previously treated with a pediculicide within 4 weeks prior to study enrollment
- Individuals using hair dyes, bleaches, permanent waves or relaxing solutions 2 weeks prior to study enrollment
- Individuals who have participated in any clinical trial within 30 days of enrollment
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 Creme Rinse - Vehicle ControlOne or two, 10-minute topical applications (7 days apart) | Drug | 1 |
| Spinosad Creme Rinse0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart) | Drug | 2 |
| Spinosad Creme Rinse1.0% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart) | Drug | 3 |
| Spinosad Creme Rinse2.0% Spinosad Creme Rinse - one or two, 10-minute topical applications (7 days apart) | Drug | 4 |
Primary outcome
Efficacy of various doses of Spinosad, based on the presence or absence of live lice at 7 and 14 days post-treatment. The efficacy evaluation was performed by a trained evaluator.
Time frame: 14 days
1 secondary outcome
Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation.
Time frame: 14 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 Oct 2015.
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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.
Dyal Garg, Ph.D. 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 2 study testing Spinosad Creme Rinse in people with Pediculosis Capitis and 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 6 inclusion and 8 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 Oct 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Efficacy of various doses of Spinosad, based on the presence or absence of live lice at 7 and 14 days post-treatment. The efficacy evaluation was performed by a trained evaluator. (time frame: 14 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 Oct 2015.