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

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ClinicalTrials.gov Identifier: NCT03178942
Recruitment Status : Completed
First Posted : June 7, 2017
Results First Posted : March 14, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
Novum Pharmaceutical Research Services
Information provided by (Responsible Party):
Encube Ethicals Pvt. Ltd.

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

Condition or disease Intervention/treatment Phase
Scabies Drug: Permethrin Cream, 5% Drug: Elimite™ Cream (permethrin) 5% Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be assigned to the test or reference permethrin to treat scabies.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The study product will be randomized, packaged and blinded so that the packaging for both treatments look identical.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : November 11, 2017
Actual Study Completion Date : November 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scabies
Drug Information available for: Permethrin

Arm Intervention/treatment
Active Comparator: Reference: Elimite™ Cream
Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.)
Drug: Elimite™ Cream (permethrin) 5%
Permethrin Cream 5%
Other Name: Elimite™ Cream

Experimental: Test: Permethrin Cream, 5%
Test: Permethrin Cream, 5% (Encube Ethicals)
Drug: Permethrin Cream, 5%
Permethrin Cream 5%




Primary Outcome Measures :
  1. Number of Patients in Each Treatment Group With Therapeutic Cure (Parasitological Cure Plus Clinical Cure) of Scabies [ Time Frame: Day 28 ± 4 ]

    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).



Other Outcome Measures:
  1. Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days. [ Time Frame: Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days ]

    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).


  2. 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. [ Time Frame: Visit 2 within 14 ± 2 days and Visit 3 between Day 26 and Day 32, inclusive. ]

    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).


  3. Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days. [ Time Frame: Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days ]

    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).




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. 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.

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): NCT03178942


Locations
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United States, Arkansas
Applied Research Center of Arkansas
Little Rock, Arkansas, United States, 72212
United States, California
St. Josephs Clinical Research
Anaheim, California, United States, 92804
Long Beach Clinical Trials
Long Beach, California, United States, 90806
Havana Research Institute
Pasadena, California, United States, 91105
United States, Florida
Integrity Clinical Research Center, Inc.
Hialeah, Florida, United States, 33015
The Chappel Group Research
Kissimmee, Florida, United States, 34744
Lenus Research & Medical Group, LLC
Sweetwater, Florida, United States, 33172
United States, Pennsylvania
DermDox Cetners for Dermatology
Hazleton, Pennsylvania, United States, 18201
United States, Texas
West Houston Clinical Research Services
Houston, Texas, United States, 77055
Sun Research Instiute
San Antonio, Texas, United States, 78215
El Salvador
Clinica Dermatologica/APF Research International
San Salvador, El Salvador, O1101
Clinica Dermatologica Y Cirugia de Piel/APF Research International
San Salvador, El Salvador, O1501
Clinica de la Doctora Laura Vargas
San Salvador, El Salvador
Puerto Rico
APF Research International
Aguas Buenas, Puerto Rico, OO703
APF Research International
Loiza, Puerto Rico, OO772
Sponsors and Collaborators
Encube Ethicals Pvt. Ltd.
Novum Pharmaceutical Research Services
Investigators
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Study Director: Pratik Kamani Encube Ethicals Pvt. Ltd.
  Study Documents (Full-Text)

Documents provided by Encube Ethicals Pvt. Ltd.:
Study Protocol  [PDF] November 3, 2017
Statistical Analysis Plan  [PDF] November 2, 2017


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Responsible Party: Encube Ethicals Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT03178942     History of Changes
Other Study ID Numbers: 71675502
First Posted: June 7, 2017    Key Record Dates
Results First Posted: March 14, 2019
Last Update Posted: March 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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