Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.

NCT02978508 | Completed Phase 3 Results

• 1 other identifier: MAP-8184
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multi-center, double-blind, randomized, two arm parallel design study. This study is comprised of two phases: screening and treatment. The screening period will be up to 5 days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will be randomized to receive either test or reference treatments in a double-blind manner in an outpatient setting. Randomization of subjects will be in a 1:1 ratio for the test and reference drug arms and will be stratified by site. Screening will begin at visit 1, during which eligibility will be determined and prohibited treatments will be discontinued. Randomization will occur following the confirmation of the eligibility criteria at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The treatment phase will be 28±4 days in duration wherein subject will receive treatment with investigational product (either test or reference) on Day 1 or Baseline (visit 2). Safety and tolerability assessments will be performed on Day 7 (visit 3). Efficacy, safety and tolerability will be assessed on Day 14 (visit 4) followed by the End of study visit on Day 28 (visit 5). If positive identification of scabies is confirmed at Day 14 (visit 4), the subject will be retreated with the second application of the investigational product.

Conditions

Scabies

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients That Are Identified as Cured.

  To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.

  Day 28

Secondary Outcomes (1)

• Proportion of Patients That Are Identified as Cured.

  Day 14

Study Arms (2)

Permethrin Cream, 5%

EXPERIMENTAL

Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.

Drug: Permethrin Cream, 5%

Elimite

ACTIVE COMPARATOR

Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. ("Prestium"), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.

Drug: Elimite

Interventions

Permethrin Cream, 5% DRUG

Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.

Permethrin Cream, 5%

Elimite DRUG

Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.

Also known as: Permethrin Cream, 5%

Elimite

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-lactating female subject at least 12 years of age or older.
• Subject must have a positive identification for mites, eggs, or mite fecal matter by microscopic examination of a skin scraping.
• Subjects must have at least two of the three following: a) excoriations and inflammatory papules with a typical distribution pattern and localization (webbed spaces of the fingers, flexor surfaces of the wrists, elbows, axillae, belt line, feet, skin surface of external genitalia, or areolae); b) presence of burrows; c) family or contacts with moderate to severe itching which increases during the night.
• Subjects must be willing to make every effort to immediately disinfect clothes, towels, and linens and all potentially infected household items upon diagnosis of infestation to prevent re-infestation.
• All household members with prolonged physical contact with the subject must be willing to attend Baseline visit and receive treatment with standard of care if deemed necessary by the Investigator in order to prevent re-infestation of the subject enrolled.
• Subject or representative must read and sign an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved Informed Consent Form (ICF); for minor subjects (18 years or younger in most states) the parent or legal guardian should sign the ICF and the child will be required to sign the Assent Form that will written in such a way as to be understandable to a child.
• Subject must be able to apply study product to self. If the subject is a child, then parent/guardian will apply study product to him/her.

You may not qualify if:

• Females who are pregnant as shown in a urine pregnancy test at the Baseline visit, prior to randomization, or lactating, or of childbearing potential (for purpose of this study a female of childbearing potential is considered to be not surgically sterile or postmenopausal for at least 1 year) who are not using or do not agree to use an acceptable form of contraception (oral /implant /injectable /transdermal contraceptives, intrauterine device (IUD), condom, diaphragm, or abstinence) during the study, or who intends to become pregnant during the study; contraceptive method must also be consistent throughout the study.
• Treatment for scabies \<4 weeks prior to enrollment, including permethrin, benzyl alcohol, lindane, crotamiton, malathion, and ivermectin.
• Use of prohibited medications:
• Topical or oral scabicidal/antiparasitic treatment including: permethrin, benzyl alcohol, benzyl benzoate, lindane, crotamiton, malathion, ivermectin, precipitated sulfur, albendazole, keratolytic cream, tea tree oil, or oil of the leaves of Lippia multiflora Moldenke within 28 days of visit 2.
• Systemic corticosteroids (including inhaled steroids) taken within 14 days of visit 2.
• Topical corticosteroids including hydrocortisone taken within 24 hours of visit 2.
• Topical antipruritics, including antihistamines within 24 hours of any study visits.
• Oral antihistamine including diphenhydramine (Benadryl) taken within 24 hours of any study visits.
• Topical antibiotics including mupirocin taken within 24 hours of any study visits.
• Patients with immunosuppressive disorders requiring therapy, severe systemic disease, history of HIV infection and/or seizures.
• Patients with crusted/Norwegian scabies.
• Presence of underlying skin disease that would obscure evaluation of the papules and burrows associated with scabies infection as determined by the Investigator.
• Presence of severe cutaneous bacterial or fungal infections requiring therapy (including systemic and topical antibiotics) as determined by the Investigator.
• Sensitivity or allergy to Permethrin Cream or any of its components, synthetic pyrethroids, pyrethrin, chrysanthemums or ragweed.
• A recent (less than 1 year) history of alcoholism, drug abuse, or other problems which would likely make the subject unreliable for the study.

Sponsors & Collaborators

• Mayne Pharma International Pty Ltd: lead
• bioRASI, LLC: collaborator

Study Sites (3)

LCC Medical Research Institute

Miami, Florida, 33126, United States

Location

Southcoast Research Center

Miami, Florida, 33136, United States

Location

Mid Columbia Research

Richland, Washington, 99352, United States

Location

MeSH Terms

Conditions

Scabies

Interventions

Permethrin

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrethrins; Cyclopentane Monoterpenes; Monoterpenes; Terpenes

Results Point of Contact

• Title: Associate Director, Clinical Operations
• Organization: Mayne Pharma LLC

phoevos.hughes@maynepharma.com

919 573 7948

Study Officials

• Phoevos Hughes, JD

  bioRASI, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: December 1, 2016
• Study Start: November 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 2, 2020
• Results First Posted: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)