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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572986
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : October 14, 2016
Sponsor:
Collaborator:
Novum Pharmaceutical Research Services
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Scabies Drug: Permethrin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scabies
Drug Information available for: Permethrin

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



Primary Outcome Measures :
  1. Proportion of patients with therapeutic cure (parasitological cure plus clinical cure) of scabies [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. The proportion of patients with no itch persistence [ Time Frame: Day 28 ]

Other Outcome Measures:
  1. Adverse events assessment [ Time Frame: Day 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02572986


Locations
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United States, Arizona
Omni Dermatology
Phoenix, Arizona, United States, 85018
United States, California
Sun Rise Clinical Research, Inc
Bell Gardens, California, United States, 90201
Havana Research Institute
Pasadena, California, United States, 91105
United States, Florida
Solutions Through Advanced Research
Jacksonville, Florida, United States, 32258
San Marcus Research Clinic, Incorporation
Miami, Florida, United States, 33015
L & C Professional Medical Research Institute
Miami, Florida, United States, 33144
Vista Health Research, LLC
Miami, Florida, United States, 33176
United States, Pennsylvania
Derm Dx Center for Dermatology
Hazleton, Pennsylvania, United States, 18201
United States, Texas
Sun Research Institute
San Antonio, Texas, United States, 78215
United States, Washington
Zain Research, LLC
Richland, Washington, United States, 99352
El Salvador
Clinica Dermatologica
San Salvador, El Salvador
Clinica Dermatologica y Cirugia de Piel
Santa Tecla, La Libertad, El Salvador
Panama
Clinica Dermatologica Dra. Yariela Grajales
Ciudad de Panama, PanamaCity, Panama
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Novum Pharmaceutical Research Services
Investigators
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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
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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT02572986    
Other Study ID Numbers: DRL-USG02-P/2015
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2015
Additional relevant MeSH terms:
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Scabies
Mite Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases
Permethrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action