A Pilot Dose Ranging Study of Spinosad Creme Rinse
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ClinicalTrials.gov Identifier: NCT00858481 |
Recruitment Status :
Completed
First Posted : March 9, 2009
Last Update Posted : October 20, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pediculosis Capitis Head Lice | Drug: Spinosad Creme Rinse - Vehicle Control Drug: Spinosad Creme Rinse | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | November 2005 |
Actual Study Completion Date : | November 2005 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1
Vehicle control
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Drug: Spinosad Creme Rinse - Vehicle Control
One or two, 10-minute topical applications (7 days apart) |
Active Comparator: 2
0.5% Spinosad creme rinse
|
Drug: Spinosad Creme Rinse
0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart) |
Active Comparator: 3
1.0% Spinosad Creme Rinse
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Drug: Spinosad Creme Rinse
1.0% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart) |
Active Comparator: 4
2.0% Spinosad Creme Rinse
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Drug: Spinosad Creme Rinse
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 ]

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Ages Eligible for Study: | 2 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858481
United States, Florida | |
Hill Top Research | |
West Palm Beach, Florida, United States, 33409 |
Principal Investigator: | Dyal Garg, Ph.D. | Hill Top Research |
Responsible Party: | Dyal Garg, Ph.D., Principal Investigator, Hill Top Research |
ClinicalTrials.gov Identifier: | NCT00858481 |
Other Study ID Numbers: |
SPN-201-05 HTR-124235 |
First Posted: | March 9, 2009 Key Record Dates |
Last Update Posted: | October 20, 2015 |
Last Verified: | October 2015 |
Pediculosis capitis Head Lice |
Lice Infestations Ectoparasitic Infestations Skin Diseases, Parasitic Parasitic Diseases |
Infections Skin Diseases, Infectious Skin Diseases |