A Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies

October 22, 2020 updated by: Saptalis Pharmaceuticals LLC

A Double Blind, Two Arm, Multicenter, Randomized, Parallel Group, Bioequivalence Study With Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of Permethrin Cream 5% & Elimite™ in Subjects With Scabies

This phase III study was conducted to establish the clinical bioequivalence of Permethrin Cream 5% and Elimite™ in the treatment of scabies following a single application.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Double Blind, Two Arm, Multicenter, Randomized, Parallel Group Bioequivalence Study with Clinical Endpoints to Evaluate the Safety and Therapeutic Equivalence of, Permethrin Cream 5% (Manufactured by Saptalis Pharmaceuticals, LLC) & Elimite™ (Permethrin Cream 5%, manufactured for Prestium Pharma, Inc.) in Subjects with Scabies.

The objectives of this study are:

Primary Objective: To establish the clinical bioequivalence of Permethrin Cream 5% (manufactured by Saptalis Pharmaceuticals, LLC) and Elimite™ (Permethrin Cream 5%, manufactured for Prestium Pharma, Inc.) in the treatment of scabies (Sarcoptes scabiei) following a single application.

Secondary Objective: To compare the safety and tolerability between the study drugs.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Dinuba, California, United States, 93618
        • Universal Biopharma Research Institute Inc.
      • Long Beach, California, United States, 90806
        • Long Beach Clinical Trials Services, Inc.
      • Pasadena, California, United States, 91105
        • Havana Research Institute
    • Florida
      • Miami, Florida, United States, 33136
        • SouthCoast Research Center, Inc (Clinical Site & Drug Shipment Facility)
    • Texas
      • Houston, Texas, United States, 77055
        • West Houston Clinical Research Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 63 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects and/or parent/guardian must have understood and signed appropriately administered informed consent/assent in their own language
  • Healthy male and non-pregnant/non-lactating female subjects aged 2 months to 65 years diagnosed with scabies
  • Must have dermatological evidence of active scabies (burrows, erythematous papules, etc.) confirmed by recovery of live Sarcoptes scabiei (the Principal investigator or trained and experienced Study Team examines the specimen(s) under magnification to verify the identity and viability of the scabies mite, ova, or mite feces at the site)
  • The youngest subject (with scabies infestation as defined above) from each household is considered the index or primary subject of the household for evaluation of the primary endpoint. Other members of the household and close contacts are enrolled in the study as Secondary subjects and evaluated for all safety parameters (not included in primary endpoint analysis). Secondary subjects that are confirmed to have dermatological evidence of scabies should receive the same study treatment as the Index subject
  • Must be available and willing to report for follow up visits
  • Is otherwise healthy, well-nourished, non-febrile and not suffering from an infection likely to require systemic antibiotic or topical therapy. These criteria will be ascertained during screening by the Principal investigator
  • Must agree not to use other scabicides or other medications likely to affect the evaluation of their response to scabies treatment
  • If female of childbearing potential, willing to use an acceptable method of birth control, should be stable for 3 months prior to screening and throughout the study
  • Must be willing to follow the procedures to decrease infestation: Clothes and bed linens that were in contact with the subjects, their household members and close contacts during the previous 48 to 72 hours will be machine washed at 60°C and machine dried the day after the first treatment. For materials that cannot be laundered, insecticide powder or aerosolized insecticide may be used, or the items may be kept in a sealed bag for at least 48 to 72 hours.

Exclusion Criteria:

  • Subject or parent/guardian has not signed informed consent/assent
  • Pregnant females, lactating females or females planning for a pregnancy
  • Females of childbearing potential who do not agree to utilize an adequate method of contraception
  • Known history of irritation or sensitivity to parasiticides
  • Skin conditions that could make it difficult to evaluate the extent of an infestation or would present a problem in the evaluation of response to therapy (e.g. atopic dermatitis, eczema, contact dermatitis, lichen planus, papular urticaria, seborrheic dermatitis).
  • Use within 4 weeks of baseline visit (1) immunomodulators (2) systemic medications that suppress the immune system (3) topical or oral parasiticides.
  • Use within 2 weeks of baseline visit (1) topical steroids (2) topical or systemic antibiotics
  • Has crusted scabies • Known allergy or hypersensitivity to permethrin, any synthetic pyrethroid or pyrethrin, plants in the Asteraceae/Compositae family (e.g. chrysanthemums, ragweed, marigolds, and daisies)
  • Subjects whose household members and close contacts refuse treatment.
  • Subjects with greater than 5 infested household members and close contacts
  • Subjects whose sexual contacts do not agree to restrict prolonged skin to skin contact with non-household members during the study period
  • Subjects with a household member less than 2 months of age
  • Suffers from a renal or hepatic impairment
  • Has been treated for scabies by any form of scabies treatment whether prescription, over-the-counter or a home remedy within a month prior to their screening visit
  • Had received or used an investigational new drug within the month immediately preceding the screening
  • Is receiving any medication likely to mask or modify scabies
  • Will not be available for follow up visits
  • Has other cutaneous conditions which might be confused with scabies
  • Seriously immune suppressed subjects
  • Has been previously empaneled in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Drug Treatment Arm
Permethrin Cream 5%, Saptalis Pharmaceuticals, LLC
Patients will be assigned to the test product Permethrin Cream 5% to the Reference Listed Drug Product Elimite cream.
Active Comparator: Reference Drug Treatment Arm
Elimite™ (Permethrin Cream 5%), Prestium Pharma, Inc.
Patients will be assigned to the test product Permethrin Cream 5% to the Reference Listed Drug Product Elimite cream.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint is the proportion of index subjects in the Per Protocol (PP) population in each treatment group with treatment cure when examined at Visit 4 (Day 28 ± 2 Days).
Time Frame: Day 28 ± 2 Days
Cure is defined as demonstration of clinical cure (all clinical findings have completely resolved, including inflammatory/non-inflammatory lesions) and microscopic cure (demonstration of the absence of mites, ova, and/or mite feces) on Day 28. Negative microscopy can be declared if no mites, ova, or mite feces is found from a minimum of 3 skin scrapings from previously affected sites.
Day 28 ± 2 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2018

Primary Completion (Actual)

November 13, 2018

Study Completion (Actual)

December 6, 2018

Study Registration Dates

First Submitted

May 30, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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