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| Name | Class |
|---|---|
| South Florida Family Health and Research Centers | NETWORK |
| Axis Clinical Trials | OTHER |
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To establish the therapeutic equivalence and safety of a generic Benzyl Alcohol Lotion 5% with Ulesfia Lotion 5% in eradication of head lice in the study subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benzyl Alcohol Lotion 5% | Experimental | Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. |
|
| Ulesfia (Benzyl Alcohol Lotion 5%) | Active Comparator | Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. |
|
| Vehicle Placebo Lotion 0% | Placebo Comparator | Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benzyl Alcohol Lotion 5% | Drug | White topical lotion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Infestation Successfully Eliminated by Active Treatment. | Successful elimination of infestation by active treatment [Time frame: 22 + 2 days]. No evidence of active head lice infestation 22 days after enrollment. | Study Day 22 +/-2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Rivera | South Florida Family Health and Research Centers | Principal Investigator |
| Lydie Hazan, MD | Axis Clinical Trials | Principal Investigator |
| Patrick Clarke, MD | Axis Clinical Trials | Principal Investigator |
| Lidia E Serrano | South Florida Family Health and Research Centers | Principal Investigator |
| Nancy Pyram-Bernard, D.O. | South Florida Family Health and Research Centers | Principal Investigator |
| Ian F Burgess, M.Phil. | Insect Research and Development LTD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Axis Clinical Trials | Los Angeles | California | 90017 | United States | ||
| Axis Clinical Trials |
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| ID | Title | Description |
|---|---|---|
| FG000 | Benzyl Alcohol Lotion 5% | Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. Benzyl Alcohol Lotion 5%: White topical lotion |
| FG001 | Ulesfia (Benzyl Alcohol Lotion 5%) | Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. Ulesfia (benzyl alcohol lotion) 5%: White topical lotion |
| FG002 | Vehicle Placebo Lotion 0% | Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. Placebo: White topical lotion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Benzyl Alcohol Lotion 5% | Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. Benzyl Alcohol Lotion 5%: White topical lotion |
| BG001 | Ulesfia (Benzyl Alcohol Lotion 5%) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Infestation Successfully Eliminated by Active Treatment. | Successful elimination of infestation by active treatment [Time frame: 22 + 2 days]. No evidence of active head lice infestation 22 days after enrollment. | PP | Posted | Count of Participants | Participants | Study Day 22 +/-2 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Benzyl Alcohol Lotion 5% | Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. Benzyl Alcohol Lotion 5%: White topical lotion |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin, nervous system and general disorder | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Hot paraesthesia on scalp |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elisabeth Rivera | South Florida Family Health & Research | 3053870051 | elisabeth@sffhrc.com |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D001592 | Benzyl Alcohols |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D001593 | Benzyl Compounds |
| D001555 | Benzene Derivatives |
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| Ulesfia (benzyl alcohol lotion) 5% |
| Drug |
White topical lotion |
|
| Placebo | Drug | White topical lotion |
|
| Los Angeles |
| California |
| 90036 |
| United States |
| South Florida Family Health and Research Centers (Lice Source Services Inc) | Miami | Florida | 33186 | United States |
| South Florida Family Health and Research Centers (Lice Source Services Inc) | Plantation | Florida | 33313 | United States |
Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. Ulesfia (benzyl alcohol lotion) 5%: White topical lotion |
| BG002 | Vehicle Placebo Lotion 0% | Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. Placebo: White topical lotion |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Vehicle Placebo Lotion 0% | Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. Placebo: White topical lotion |
|
|
| 0 |
| 107 |
| 0 |
| 107 |
| 2 |
| 107 |
| EG001 | Ulesfia (Benzyl Alcohol Lotion 5%) | Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. Ulesfia (benzyl alcohol lotion) 5%: White topical lotion | 0 | 108 | 0 | 108 | 1 | 108 |
| EG002 | Vehicle Placebo Lotion 0% | Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out. Placebo: White topical lotion | 0 | 24 | 0 | 24 | 0 | 24 |
|
| redness of eye | Eye disorders | Non-systematic Assessment | redness of eyes |
|
| fever | General disorders | fever |
|
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |