Clinical Endpoint Study of Ivermectin 0.5% Lotion | NCT03301649

NCT03301649

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Teva Pharmaceuticals USA	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Generic Ivermectin Lotion 0.5%	Experimental	Infested household participants will administer a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to the dry hair (avoiding contact with eyes) at home on Day 1, leave the lotion on the hair and scalp for 10 minutes, and then rinse off with warm water. Participants will be instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel is permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants are not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit has been completed.	Drug: Generic Ivermectin Lotion 0.5%
Sklice (Ivermectin) Lotion 0.5%	Active Comparator	Infested household participants will administer a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to the dry hair (avoiding contact with eyes) at home on Day 1, leave the lotion on the hair and scalp for 10 minutes, and then rinse off with warm water. Participants will be instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel is permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants are not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit has been completed.	Drug: Sklice® (Ivermectin) Lotion 0.5%
Vehicle Lotion	Placebo Comparator	Infested household participants will administer a single application of up to 117 grams (1 tube) of vehicle topical lotion to the dry hair (avoiding contact with eyes) at home on Day 1, leave the lotion on the hair and scalp for 10 minutes, and then rinse off with warm water. Participants will be instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel is permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants are not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit has been completed.

Name	Type	Description	Arm Group Labels	Other Names
Generic Ivermectin Lotion 0.5%	Drug	Topical lotion, generic formulation of the brand product.	Generic Ivermectin Lotion 0.5%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Index Participants Who Were Considered a Treatment Success: PP Population	Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice [ivermectin] lotion 0.5%) was done in this endpoint, hence placebo group was not included.	Day 15 ± 2
Percentage of Index Participants Who Were Considered a Treatment Success: mITT Population	Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study.	Day 15 ± 2

Secondary Outcomes

Measure	Description	Time Frame
Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: PP Population	Treatment success was defined as the absence of live lice. Non-index participant: Any household member who agreed to participate in the study but was not the youngest household member. Index participant: The youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice [ivermectin] lotion 0.5%) was done in this endpoint, hence placebo group was not included.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed Institutional Review Board (IRB)-approved informed consent form that meets all criteria of current FDA regulations. For participants who are considered minors in the state the study is being conducted (<18 years in most states), the parent or legal guardian should sign the consent form and the child will be required to sign a participant "assent" form, as appropriate. Participants 11-17 years of age will read and sign an IRB-approved assent form and participants 6-10 years of age will provide verbal assent. Participants 6 months-5 years of age will be exempt from providing assent based on the child's comprehension and cognitive skills.
The participant and/or the participant's parent (legal guardian) is willing to apply the study product as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
Male or non-pregnant, non-lactating female, 6 months of age or older.
Females of childbearing potential must not be pregnant or lactating at Visit 1 (Day -1 to 1) (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 milli-international units/milliliter [mIU/mL] or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception. (for example, total abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected, or implanted non-hormonal or hormonal contraceptive) throughout the study. Female participants using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before Visit 1 (Day -1 to 1) and should not change this regimen during the study. A sterile sexual partner is not considered an adequate form of birth control.
Index participants (that is, the youngest household member) must have an active head lice infestation, defined as ≥3 live lice (that is, live adults and/or nymphs), at Visit 1 (Day -1 to 1).
Household members participating in the study must have ≥1 live louse (that is; live adults and/or nymphs) at Visit 1 (Day -1 to 1).
All members of the household must be present for examination. Any male head of household who is unable to attend Visit 1 (Day -1 to 1) may be assessed by a second member of the household as being lice free.

Exclusion Criteria:

Females who are pregnant, lactating or planning to become pregnant during the study period.
Participants who do not have a known household affiliation with their household members (that is, do not stay in 1 household consistently, sleeping at 1 place several nights and then at another place or location). Household is defined as living in a shared area or space (for example the same house or apartment unit).
Any infested member of the household is unable or unwilling to be treated with the study product. This includes male heads of household who do not attend Visit 1 (Day -1 to 1) but report infestation with lice.
More than 3 members of the household infested with lice.
Presence of visible skin/scalp condition(s) or open wounds at the application site that are not attributable to head lice infestation and that in the opinion of the Investigator will interfere with safety and/or efficacy evaluations.
Presence of eczema or atopic dermatitis at the application site.
Use of any prescription, over-the-counter, or home remedies for the treatment of head lice within 7 days before Visit 1 (Day -1 to 1).
Use of pediculicides within 4 weeks before Visit 1 (Day -1 to 1).
Use of systemic anti-parasitic agents within four weeks before Visit 1.
Participants with very short (shaved) hair or who are planning to shave head during the study.
Use of any hair dye, bleaches, hair straightening, or permanent wave solution on the hair within 14 days before Visit 1 (Day -1 to 1).
History of allergy or sensitivity to pediculicides or hair care products.
History of any drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the participant or results of the study.
Significant history or current acute or chronic infectious disease, system disorder, Netherton's Syndrome, organ disorder (for example, hepatic or renal impairment) or insufficiency, immunosuppression (from medical treatment or disease), organ transplant, uncontrolled diabetes, uncontrolled hypertension, current ocular condition, or other medical condition that, in the Investigator's opinion, would place the study participant at undue risk by participating in the study.
Participants or non-infested household members who would act as the primary caregiver who are of intellectually competent age but unable to understand the protocol requirements, instructions, and study-related restrictions, the nature, scope, and possible consequences of the clinical study.
Receipt of any drug as part of a research study within 30 days before Visit 1 (Day -1 to 1).
The participant is a member of the investigational study staff or a member of the family of the investigational study staff.
Previous participation in this study.

Name	Affiliation	Role
Study Director	Actavis Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site 1		Miami	Florida	33134	United States

Label	URL
Related Info	View source

Arm/Group Information

ID	Title	Description
FG000	Generic Ivermectin Lotion 0.5%	Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
FG001	Sklice (Ivermectin) Lotion	Infested household participants administered a single application of up to 117 grams (1 tube) of Sklice ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.
FG002	Vehicle Lotion	Infested household participants administered a single application of up to 117 grams (1 tube) of vehicle topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Generic Ivermectin Lotion 0.5%	Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Percentage of Index Participants Who Were Considered a Treatment Success: PP Population

Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice [ivermectin] lotion 0.5%) was done in this endpoint, hence placebo group was not included.

Index participants in PP population. PP population: randomized participants who met all eligibility criteria, applied study drug, were treatment successes/failures and made the final study visit ( Day 15 ± 2), and had no significant protocol deviations.

Posted

Number

percentage of participants

Day 15 ± 2

ID	Title	Description
OG000	Generic Ivermectin Lotion 0.5%	Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Generic Ivermectin Lotion 0.5%	Infested household participants administered a single application of up to 117 grams (1 tube) of generic ivermectin 0.5% topical lotion to dry hair (avoiding contact with eyes) at home on Day 1, left the lotion on the hair and scalp for 10 minutes, and then rinsed off with warm water. Participants were instructed to wash their hands after application of the study drug, allow hair to dry naturally (pat drying with decontaminated towel was permitted), and to leave hair uncovered after application of the study drug. Following application and rinsing of the study drug, participants were not to shampoo, wash, or rinse their hair or scalp until the Day 2 visit had been completed.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 1, 2018	Nov 1, 2019	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Jan 12, 2018	Nov 1, 2019	SAP_001.pdf

ID	Term
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930	Organic Chemicals