A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies

A Randomized, Double-Blind, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% to Elimite™ Cream 5% in the Treatment of Scabies

Scabies is an infestation of the skin by the human itch mite (Sarcoptes scabiei). Diagnosis of scabies is made based on clinical symptoms, such as nocturnal itching, and appearance and distribution of the rash. Definitive diagnosis includes the microscopic identification of the mite, mite eggs, or mite fecal matter in the skin. Topical permethrin is considered the drug of choice for the treatment of scabies. It is a synthetic pyrethroid that is safe for use in adults and children 2 months and older.

This study will evaluate the therapeutic equivalence of a generic permethrin cream 5% to Elimite® in the Treatment of Scabies.

Study Overview

• Status: Completed
• Conditions: Scabies
• Intervention / Treatment: Drug: Permethrin

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 3

Contacts and Locations

Study Locations

• El Salvador
  • San Salvador, El Salvador
    • Clinica Dermatologica
  • Santa Tecla, La Libertad, El Salvador
    • Clinica Dermatologica y Cirugia de Piel
• Panama
  • PanamaCity
    • Ciudad de Panama, PanamaCity, Panama
      • Clinica Dermatologica Dra. Yariela Grajales
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Omni Dermatology
  • California
    • Bell Gardens, California, United States, 90201
      • Sun Rise Clinical Research, Inc
    • Pasadena, California, United States, 91105
      • Havana Research Institute
  • Florida
    • Jacksonville, Florida, United States, 32258
      • Solutions Through Advanced Research
    • Miami, Florida, United States, 33176
      • Vista Health Research, LLC
    • Miami, Florida, United States, 33015
      • San Marcus Research Clinic, Incorporation
    • Miami, Florida, United States, 33144
      • L & C Professional Medical Research Institute
  • Pennsylvania
    • Hazleton, Pennsylvania, United States, 18201
      • Derm Dx Center for Dermatology
  • Texas
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute
  • Washington
    • Richland, Washington, United States, 99352
      • Zain Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed Informed Consent that meets all criteria of current FDA regulations.
2. Male or non-pregnant, non-lactating female at least 2 years of age or older.
3. Diagnosis of active scabies by presence of a burrow and/or typical scabietic lesions at the classic sites of infestation.
4. Parasitological confirmation of clinical diagnosis with demonstration under light microscope of mites and/or their products (larvae, eggs or fecal material).
5. Symptom score of 2 or 3 on a 4-point rating scale of 0-3 for nocturnal itching.

6. Women must be either 1 year post-menopausal (no menstrual periods for at least 12 months), surgically sterile, or if they are of child-bearing potential, they must:

   • Have been using systemic birth control, intrauterine device, or used barrier methods such as diaphragm plus spermicide or condom plus spermicide consistently, at least 14 days before study cream administration.
   • Had a normal menstrual cycle for the month before start of treatment.
   • Have a negative urine pregnancy test result upon entry into the study.
   • Agree to use a medically accepted form of birth control (oral, implant, injectable or transdermal contraceptives, intrauterine device, condom plus spermicide, diaphragm plus spermicide) or practice abstinence throughout the study period.
7. Free from 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.
8. Ability to apply study product to self or to other person if a child. If patient is a child, then parent/guardian will apply study product to him/her.

Exclusion Criteria:

1. Known hypersensitivity to permethrin cream or any of its components, ragweed or chrysanthemums, synthetic pyrethroids or pyrethrin.
2. Use of any systemic or topical acaricide 1 month before enrollment.
3. Patients with crusted/Norwegian scabies.
4. Patients with an underlying immunodeficient state (including prolonged treatment with corticosteroids), immunosuppressive disorders requiring therapy, severe systemic disease and history of HIV infection.
5. Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study.
6. Women who are pregnant, planning pregnancy or lactating.
7. Family members of employees of the clinic or Investigator.
8. Patients who, in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol.
9. Patients whose close personal contacts will not or are not willing to comply with standard of care for Scabies management.
10. Patients less than 2 years of age.
11. Patients or guardians of patients, who are unable or unwilling to give informed consent or assent respectively.
12. Receipt of any drug as part of a research study within 30 days before screening.
13. History of seizures.
14. 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.
15. Treatment with systemic or topical corticosteroids less than 2 weeks and less than 1 week from enrollment, respectively.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Permethrin cream 5%; Manufactured by Dr. Reddy's Laboratories, Ltd	Drug: Permethrin
Active Comparator: Elimite™ Cream (permethrin) 5%; Manufactured by Prestium Pharma, Inc	Drug: Permethrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with therapeutic cure (parasitological cure plus clinical cure) of scabies	Day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients with no itch persistence	Day 28

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events assessment	Day 28

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Collaborators: Novum Pharmaceutical Research Services
• Investigators: Study Director: Ashis Patnaik, MD, Dr. Reddy's Laboratories Limited; Study Director: Prasanna Ganapathi, MD, Dr. Reddy's Laboratories Limited; Study Director: Shilpi Dhawan, MD, Dr. Reddy's Laboratories Limited

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: October 8, 2015
• First Submitted That Met QC Criteria: October 8, 2015
• First Posted (Estimate): October 9, 2015

Study Record Updates

• Last Update Posted (Estimate): October 14, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Mite Infestations; Scabies; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Permethrin
• Other Study ID Numbers: DRL-USG02-P/2015