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

NCT ID: NCT03178942

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2017-11-11

Brief Summary

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

Detailed Description

A Randomized, Double-Blind, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream 5% (Encube Ethicals) Compared to Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) in the Treatment of Scabies.

The objectives of this study are to:

1. Evaluate the therapeutic equivalence of the Test formulation, Permethrin Cream, 5% (Encube Ethicals) to the marketed product, Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) in patients with scabies.

2. Compare the safety of Test and Reference treatments in patients with scabies.

Conditions

Scabies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Reference: Elimite™ Cream

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

Group Type: ACTIVE_COMPARATOR

Elimite™ Cream (permethrin) 5%

Intervention Type: DRUG

Permethrin Cream 5%

Test: Permethrin Cream, 5%

Test: Permethrin Cream, 5% (Encube Ethicals)

Group Type: EXPERIMENTAL

Permethrin Cream, 5%

Intervention Type: DRUG

Permethrin Cream 5%

Interventions

Permethrin Cream, 5%

Permethrin Cream 5%

Intervention Type: DRUG

Elimite™ Cream (permethrin) 5%

Permethrin Cream 5%

Intervention Type: DRUG

Other Intervention Names

Elimite™ Cream

Eligibility Criteria

Inclusion Criteria

1. Male or non-pregnant, non-lactating female, 2 years of age or older.

2. 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.

3. 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.

4. Clinical diagnosis of active scabies by presence of a burrow and/or typical scabietic lesions at the classic sites of infestation.

5. Parasitological confirmation of clinical diagnosis with demonstration under light microscope of mites and/or their products (larvae, eggs or fecal material).

6. Symptom score of 2 or 3 on a 4-point rating scale of 0-3 for nocturnal itching/pruritus.

7. 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.

Exclusion Criteria

1. Patients who are pregnant, lactating, or planning to become pregnant during the study.

2. 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).

3. Known hypersensitivity to permethrin cream or any of its components.

4. Use of any systemic or topical acaricide or ectoparasiticide within one month before Screening.

5. Patient has signs of a systemic infection or is receiving systemic therapy for an infectious disease.

6. 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.

7. Patients with an underlying immunodeficient state (including prolonged treatment with corticosteroids), immunosuppressive disorders requiring therapy, severe systemic disease and history of HIV infection.

8. Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study.

9. Family members of employees of the clinic or Investigator.

10. Patients who, in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol.

11. Patients whose close personal contacts will not or are not willing to comply with standard of care for Scabies management.

12. Receipt of any drug as part of a research study within 30 days before Screening.

13. History of seizures.

14. Use of systemic corticosteroids within two weeks before Screening.

15. Use of topical corticosteroids within one week before Screening.

16. Previous participation in this study.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novum Pharmaceutical Research Services

INDUSTRY

Sponsor Role: collaborator

Encube Ethicals Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pratik Kamani

Role: STUDY_DIRECTOR

Encube Ethicals Pvt. Ltd.

Locations

Applied Research Center of Arkansas

Little Rock, Arkansas, United States

St. Josephs Clinical Research

Anaheim, California, United States

Long Beach Clinical Trials

Long Beach, California, United States

Havana Research Institute

Pasadena, California, United States

Integrity Clinical Research Center, Inc.

Hialeah, Florida, United States

The Chappel Group Research

Kissimmee, Florida, United States

Lenus Research & Medical Group, LLC

Sweetwater, Florida, United States

DermDox Cetners for Dermatology

Hazleton, Pennsylvania, United States

West Houston Clinical Research Services

Houston, Texas, United States

Sun Research Instiute

San Antonio, Texas, United States

Clinica Dermatologica/APF Research International

San Salvador, , El Salvador

Clinica Dermatologica Y Cirugia de Piel/APF Research International

San Salvador, , El Salvador

Clinica de la Doctora Laura Vargas

San Salvador, , El Salvador

APF Research International

Aguas Buenas, , Puerto Rico

APF Research International

Loíza, , Puerto Rico

Countries

United States; El Salvador; Puerto Rico

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

71675502

Identifier Type: -

Identifier Source: org_study_id