A Phase 2 interventional study of Spinosad Creme Rinse - Vehicle Control and Spinosad Creme Rinse in Pediculosis Capitis and Head Lice, sponsored by ParaPRO LLC. Completed at 1 site in United States. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-20.
Sponsored by ParaPRO LLC · Phase 2, Interventional, and Treatment
A pilot dose ranging study to evaluate the safety and efficacy of different strengths of Spinosad Creme versus a vehicle control.
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.
43 studies on the registry are indexed under Lice Infestations; 4 are open to participants now.
This study's enrollment of 36 is below the median of 105 across 42 interventional studies indexed under Lice Infestations.
Browse Lice Infestations studies →ParaPRO LLC is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vehicle control
Drug: Spinosad Creme Rinse - Vehicle Control
0.5% Spinosad creme rinse
Drug: Spinosad Creme Rinse
1.0% Spinosad Creme Rinse
Drug: Spinosad Creme Rinse
2.0% Spinosad Creme Rinse
Drug: Spinosad Creme Rinse
One or two, 10-minute topical applications (7 days apart)
0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
1.0% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
2.0% Spinosad Creme Rinse - one or two, 10-minute topical applications (7 days apart)
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
Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation.
Time frame: 14 days
The record gives a start of Sep 2005, a primary completion of Nov 2005 and a completion of Nov 2005. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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ParaPRO LLC