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Clinical Endpoint Study of Ivermectin 0.5% Lotion

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ClinicalTrials.gov Identifier: NCT03301649
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Actavis Inc.

Brief Summary:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of Ivermectin Lotion 0.5% (Actavis Laboratories UT, Inc.) to SKLICE® (ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC) in the Treatment of Human Head Lice Infestation

Condition or disease Intervention/treatment Phase
Head Lice Drug: Ivermectin Lotion 0.5% Drug: Placebo/Vehicle Lotion Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of Ivermectin Lotion 0.5% (Actavis Laboratories UT, Inc.) to SKLICE® (Ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC) in the Treatment of Human Head Lice Infestation
Actual Study Start Date : October 7, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arm Intervention/treatment
Experimental: Ivermectin Lotion, 0.5%
Test Product, manufactured by Actavis Laboratories UT, Inc.
Drug: Ivermectin Lotion 0.5%
Ivermectin Lotion 0.5%

Active Comparator: SKLICE® (ivermectin) Lotion, 0.5%
Reference product, manufactured by Arbor Pharmaceuticals, LLC
Drug: Ivermectin Lotion 0.5%
Ivermectin Lotion 0.5%

Placebo Comparator: Placebo (vehicle) lotion
Placebo (vehicle) lotion, manufactured by Actavis Laboratories UT, Inc.
Drug: Placebo/Vehicle Lotion
Placebo




Primary Outcome Measures :
  1. Treatment Success with Index patients [ Time Frame: 14 days after treatment ]
    Presence/Absence of live lice at Day 15 (14 days after treatment) for index patients.


Secondary Outcome Measures :
  1. Treatment Success with Randomized patients [ Time Frame: 14 days after treatment ]
    Presence/Absence of live lice at Day 15 (14 days after treatment) for non-index patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Signed Institutional Review Board (IRB)-approved informed consent form that meets all criteria of current Food and Drug Administration regulations. For patients 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 patient "assent" form, as appropriate. Patients 11-17 years of age will read and sign an IRB-approved assent form and patients 6-10 years of age will provide verbal assent. Patients 6 months-5 years of age will be exempt from providing assent based on the child's comprehension and cognitive skills.
  2. The patient and/or the patient'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.
  3. Male or non-pregnant, non-lactating female, 6 months of age or older.
  4. Females of childbearing potential must not be pregnant or lactating at Visit 1 (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU/mL or equivalent units of human chorionic gonadotropin). Women of childbearing potential must agree to the use of a reliable method of contraception. (e.g., total abstinence, intrauterine device, a double-barrier method, oral, transdermal, injected, or implanted non-hormonal or hormonal contraceptive) throughout the study. Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before Visit 1 and should not change this regimen during the study. A sterile sexual partner is not considered an adequate form of birth control.
  5. Index patients (i.e., the youngest household member) must have an active head lice infestation, defined as ≥ 3 live lice (i.e., live adults and/or nymphs), at Visit 1.
  6. Household members participating in the study must have at least one live louse (i.e., live adults and/or nymphs) at Visit 1.
  7. All members of the household must be present for examination. Any male head of household who is unable to attend Visit 1 may be assessed by a second member of the household as being lice free.

Exclusion Criteria:

  1. Females who are pregnant, lactating or planning to become pregnant during the study period.
  2. Patients who do not have a known household affiliation with their household members (i.e., do not stay in one household consistently, sleeping at one 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).
  3. 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 but report infestation with lice.
  4. More than three members of the household infested with lice.
  5. 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.
  6. Presence of eczema or atopic dermatitis at the application site.
  7. Use of any prescription, over-the-counter, or home remedies for the treatment of head lice within 7 days before Visit 1.
  8. Use of pediculicides within four weeks before Visit 1.
  9. Use of systemic anti-parasitic agents within four weeks before Visit 1.
  10. Patients with very short (shaved) hair or who are planning to shave head during the study.
  11. Use of any hair dye, bleaches, hair straightening or permanent wave solution on the hair within 14 days before Visit 1.
  12. History of allergy or sensitivity to pediculicides or hair care products.
  13. History of any drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the patient or results of the study.
  14. Significant history or current acute or chronic infectious disease, system disorder, Netherton's Syndrome, organ disorder (e.g., 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 patient at undue risk by participating in the study.
  15. Patients 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.
  16. Receipt of any drug as part of a research study within 30 days before Visit 1.
  17. The patient is a member of the investigational study staff or a member of the family of the investigational study staff.
  18. Previous participation in this study.

Information from the National Library of Medicine

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): NCT03301649


Contacts
Contact: Nageshwar Thudi, Ph.D. 9736581835 nageshwar.thudi@actavis.com
Contact: Corrine Dias, Hon.BSc. 9736580326 corrine.dias@actavis.com

Locations
United States, Florida
APF Research, LLC Recruiting
Miami, Florida, United States, 33134
Contact: Felix Perez    786-220-9450      
Sponsors and Collaborators
Actavis Inc.

Additional Information:
Responsible Party: Actavis Inc.
ClinicalTrials.gov Identifier: NCT03301649     History of Changes
Other Study ID Numbers: 71691702
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Ivermectin
Antiparasitic Agents
Anti-Infective Agents