Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% in the Treatment of Scabies

NCT03178942 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 71675502
• Study Type: interventional
• Target: 254
• Locations: 3 countries
• Sites: 15

Brief Summary

Study to Evaluate the Therapeutic Equivalence of Permethrin Cream 5%in the Treatment of Scabies.

Conditions

Scabies

Outcome Measures

Primary Outcomes (1)

• Number of Patients in Each Treatment Group With Therapeutic Cure (Parasitological Cure Plus Clinical Cure) of Scabies

  Parasitological cure is defined as failure to demonstrate microscopically the presence of scabies infestation (i.e., no living mites, no viable mite eggs, and no mite fecal matter present). Clinical cure is defined as visual evidence of absence of new lesions and healing of original lesions, regardless the presence of post-scabietic nodules (i.e., post-scabietic nodules need not be considered as new lesions or persistence of old lesions).

  Day 28 ± 4

Other Outcomes (3)

• Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days.

  Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days

• Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Between Day 26 and Day 32, Inclusive.

  Visit 2 within 14 ± 2 days and Visit 3 between Day 26 and Day 32, inclusive.

• Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days.

  Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days

Study Arms (2)

Reference: Elimite™ Cream

ACTIVE COMPARATOR

Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.)

Drug: Elimite™ Cream (permethrin) 5%

Test: Permethrin Cream, 5%

EXPERIMENTAL

Test: Permethrin Cream, 5% (Encube Ethicals)

Drug: Permethrin Cream, 5%

Interventions

Permethrin Cream, 5% DRUG

Permethrin Cream 5%

Test: Permethrin Cream, 5%

Elimite™ Cream (permethrin) 5% DRUG

Permethrin Cream 5%

Also known as: Elimite™ Cream

Reference: Elimite™ Cream

Eligibility Criteria

• Age: 2 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, 2 years of age or older.
• If female and of childbearing potential, prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., double barrier methods, intrauterine device (IUD), oral, transdermal or injected hormonal contraceptives). Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before baseline and should not change this regimen during the study.
• Signed informed consent that meets all criteria of current FDA and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) 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 Independent Review Board (IRB)-approved assent form and patients 6-10 years of age will provide verbal assent. Patients 2-5 years of age will be exempt from providing assent based on the child's comprehension and cognitive skills.
• Clinical diagnosis of active scabies by presence of a burrow and/or typical scabietic lesions at the classic sites of infestation.
• Parasitological confirmation of clinical diagnosis with demonstration under light microscope of mites and/or their products (larvae, eggs or fecal material).
• Symptom score of 2 or 3 on a 4-point rating scale of 0-3 for nocturnal itching/pruritus.
• Ability to apply or have study product applied as directed. If patient is a child, then parent/guardian will apply study product to him/her.

You may not qualify if:

• Patients who are pregnant, lactating, or planning to become pregnant during the study.
• Any systemic or dermatologic disorder that, in the opinion of the Investigator, will interfere with the study results or increase the risk of adverse events (AEs).
• Known hypersensitivity to permethrin cream or any of its components.
• Use of any systemic or topical acaricide or ectoparasiticide within one month before Screening.
• Patient has signs of a systemic infection or is receiving systemic therapy for an infectious disease.
• Patients with severe cutaneous bacterial or fungal infections requiring therapy (including systemic and topical antibiotics) or coexisting dermatological disorder that could interfere with the diagnosis and subsequent monitoring of scabies) or heavily crusted with lesions consistent with Norwegian scabies.
• Patients with an underlying immunodeficient state (including prolonged treatment with corticosteroids), immunosuppressive disorders requiring therapy, severe systemic disease and history of HIV infection.
• Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study.
• Family members of employees of the clinic or Investigator.
• Patients who, in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol.
• Patients whose close personal contacts will not or are not willing to comply with standard of care for Scabies management.
• Receipt of any drug as part of a research study within 30 days before Screening.
• History of seizures.
• Use of systemic corticosteroids within two weeks before Screening.
• Use of topical corticosteroids within one week before Screening.

Sponsors & Collaborators

• Encube Ethicals Pvt. Ltd.: lead
• Novum Pharmaceutical Research Services: collaborator

Study Sites (15)

Applied Research Center of Arkansas

Little Rock, Arkansas, 72212, United States

Location

St. Josephs Clinical Research

Anaheim, California, 92804, United States

Location

Long Beach Clinical Trials

Long Beach, California, 90806, United States

Location

Havana Research Institute

Pasadena, California, 91105, United States

Location

Integrity Clinical Research Center, Inc.

Hialeah, Florida, 33015, United States

Location

The Chappel Group Research

Kissimmee, Florida, 34744, United States

Location

Lenus Research & Medical Group, LLC

Sweetwater, Florida, 33172, United States

Location

DermDox Cetners for Dermatology

Hazleton, Pennsylvania, 18201, United States

Location

West Houston Clinical Research Services

Houston, Texas, 77055, United States

Location

Sun Research Instiute

San Antonio, Texas, 78215, United States

Location

Clinica Dermatologica/APF Research International

San Salvador, O1101, El Salvador

Location

Clinica Dermatologica Y Cirugia de Piel/APF Research International

San Salvador, O1501, El Salvador

Location

Clinica de la Doctora Laura Vargas

San Salvador, El Salvador

Location

APF Research International

Aguas Buenas, OO703, Puerto Rico

Location

APF Research International

Loíza, OO772, Puerto Rico

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: GM-Strategy & Commercial
• Organization: Encube Ethicals Pvt ltd

Pratik.K@EncubeEthicals.com

+91-22-6228-8000

Study Officials

• Pratik Kamani

  Encube Ethicals Pvt. Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study product will be randomized, packaged and blinded so that the packaging for both treatments look identical.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be assigned to the test or reference permethrin to treat scabies.

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 7, 2017
• Study Start: June 1, 2017
• Primary Completion: November 11, 2017
• Study Completion: November 11, 2017
• Last Updated: March 26, 2019
• Results First Posted: March 14, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

PR (2); US (10); EL (3)