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Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.

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ClinicalTrials.gov Identifier: NCT02978508
Recruitment Status : Completed
First Posted : December 1, 2016
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
bioRASI, LLC

Tracking Information
First Submitted Date  ICMJE November 17, 2016
First Posted Date  ICMJE December 1, 2016
Last Update Posted Date November 1, 2017
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
Proportion of patients that are identified as cured. [ Time Frame: Day 28 ]
To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
Proportion of patients that are identified as cured. [ Time Frame: Day 28 ]
Change History Complete list of historical versions of study NCT02978508 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
Proportion of patients that are identified as cured. [ Time Frame: Day 14 ]
To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
Proportion of patients that are identified as cured. [ Time Frame: Day 14 ]
Current Other Pre-specified Outcome Measures
 (submitted: October 30, 2017)
  • Safety Variable [ Time Frame: Day 28 ]
    Analysis of safety variables will be based on all adverse event (AE) capture measuring severity and duration.
  • Tolerability Assessment [ Time Frame: Day 1, Day 7, Day 14, Day 28 ]
    Analysis of tolerability will be based on scores of Stinging/Burning and Itching sensations collected during Patient Self-Assessments at visits 2-5 between the test and reference treatment groups.
Original Other Pre-specified Outcome Measures
 (submitted: November 30, 2016)
  • Analysis of safety variables will be based on all adverse event (AE) capture measuring severity and duration. [ Time Frame: Day 28 ]
  • Analysis of tolerability will be based on scores of Stinging/Burning and Itching sensations collected during Patient Self-Assessments at visits 2-5 between the test and reference treatment groups. [ Time Frame: Day 1, Day 7, Day 14, Day 28 ]
 
Descriptive Information
Brief Title  ICMJE Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.
Official Title  ICMJE A Multi-center, Double-blind, Randomized, Parallel-group Study Comparing Permethrin Cream, 5% With Elimite™ in Patients With Active Scabies.
Brief Summary

This is a multi-center, double-blind, randomized, two arm parallel design study. This study is comprised of two phases: screening and treatment. The screening period will be up to 5 days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will be randomized to receive either test or reference treatments in a double-blind manner in an outpatient setting. Randomization of subjects will be in a 1:1 ratio for the test and reference drug arms and will be stratified by site.

Screening will begin at visit 1, during which eligibility will be determined and prohibited treatments will be discontinued. Randomization will occur following the confirmation of the eligibility criteria at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The treatment phase will be 28±4 days in duration wherein subject will receive treatment with investigational product (either test or reference) on Day 1 or Baseline (visit 2). Safety and tolerability assessments will be performed on Day 7 (visit 3). Efficacy, safety and tolerability will be assessed on Day 14 (visit 4) followed by the End of study visit on Day 28 (visit 5). If positive identification of scabies is confirmed at Day 14 (visit 4), the subject will be retreated with the second application of the investigational product.

Detailed Description

Systemic absorption of permethrin cream is limited to 0.5% during the first 48 hours following dermal application. In these settings, a conventional pharmacokinetic human study to demonstrate that Mayne Permethrin cream (5% w/w) is bioequivalent to the Reference Listed Drug [RLD] Elimite™ is not appropriate.

This is a clinical endpoint bioequivalence (BE) study for a Permethrin Cream, 5% formulation for the treatment of active scabies in comparison to Elimite™ Permethrin cream (5% w/w).

  • Test Product: Permethrin Cream, 5%
  • Reference Product: Elimite™ marketed by Prestium Pharma, Inc. ("Prestium"), the branded subsidiary of Renaissance Pharma.

The infested person, as well as household members are treated at the same time to prevent re-infestation. In consideration of this recommendation, the household members of the enrolled subject will be examined and treated at the same time as the enrolled subject with an FDA-approved generic Permethrin Cream, 5%.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Scabies
Intervention  ICMJE
  • Drug: Permethrin Cream, 5%
    Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
  • Drug: Elimite
    Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
    Other Name: Permethrin Cream, 5%
Study Arms  ICMJE
  • Experimental: Permethrin Cream, 5%
    Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.
    Intervention: Drug: Permethrin Cream, 5%
  • Active Comparator: Elimite
    Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. ("Prestium"), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.
    Intervention: Drug: Elimite
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2016)
140
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or non-pregnant, non-lactating female subject at least 12 years of age or older.
  2. Subject must have a positive identification for mites, eggs, or mite fecal matter by microscopic examination of a skin scraping.
  3. Subjects must have at least two of the three following: a) excoriations and inflammatory papules with a typical distribution pattern and localization (webbed spaces of the fingers, flexor surfaces of the wrists, elbows, axillae, belt line, feet, skin surface of external genitalia, or areolae); b) presence of burrows; c) family or contacts with moderate to severe itching which increases during the night.
  4. Subjects must be willing to make every effort to immediately disinfect clothes, towels, and linens and all potentially infected household items upon diagnosis of infestation to prevent re-infestation.
  5. All household members with prolonged physical contact with the subject must be willing to attend Baseline visit and receive treatment with standard of care if deemed necessary by the Investigator in order to prevent re-infestation of the subject enrolled.
  6. Subject or representative must read and sign an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved Informed Consent Form (ICF); for minor subjects (18 years or younger in most states) the parent or legal guardian should sign the ICF and the child will be required to sign the Assent Form that will written in such a way as to be understandable to a child.
  7. Subject must be able to apply study product to self. If the subject is a child, then parent/guardian will apply study product to him/her.

Exclusion Criteria:

  1. Females who are pregnant as shown in a urine pregnancy test at the Baseline visit, prior to randomization, or lactating, or of childbearing potential (for purpose of this study a female of childbearing potential is considered to be not surgically sterile or postmenopausal for at least 1 year) who are not using or do not agree to use an acceptable form of contraception (oral /implant /injectable /transdermal contraceptives, intrauterine device (IUD), condom, diaphragm, or abstinence) during the study, or who intends to become pregnant during the study; contraceptive method must also be consistent throughout the study.
  2. Treatment for scabies <4 weeks prior to enrollment, including permethrin, benzyl alcohol, lindane, crotamiton, malathion, and ivermectin.
  3. Use of prohibited medications:

    • Topical or oral scabicidal/antiparasitic treatment including: permethrin, benzyl alcohol, benzyl benzoate, lindane, crotamiton, malathion, ivermectin, precipitated sulfur, albendazole, keratolytic cream, tea tree oil, or oil of the leaves of Lippia multiflora Moldenke within 28 days of visit 2.
    • Systemic corticosteroids (including inhaled steroids) taken within 14 days of visit 2.
    • Topical corticosteroids including hydrocortisone taken within 24 hours of visit 2.
    • Topical antipruritics, including antihistamines within 24 hours of any study visits.
    • Oral antihistamine including diphenhydramine (Benadryl) taken within 24 hours of any study visits.
    • Topical antibiotics including mupirocin taken within 24 hours of any study visits.
  4. Patients with immunosuppressive disorders requiring therapy, severe systemic disease, history of HIV infection and/or seizures.
  5. Patients with crusted/Norwegian scabies.
  6. Presence of underlying skin disease that would obscure evaluation of the papules and burrows associated with scabies infection as determined by the Investigator.
  7. Presence of severe cutaneous bacterial or fungal infections requiring therapy (including systemic and topical antibiotics) as determined by the Investigator.
  8. Sensitivity or allergy to Permethrin Cream or any of its components, synthetic pyrethroids, pyrethrin, chrysanthemums or ragweed.
  9. A recent (less than 1 year) history of alcoholism, drug abuse, or other problems which would likely make the subject unreliable for the study.
  10. Participation in another investigational study or using any investigational product within the 30 days prior to the Baseline visit.
  11. Participation of family member, or another member of the household (including regular bedmates) in the current study.
  12. Total number of bedmates and family members with prolonged physical contact is greater than 6 (including study subject).
  13. Any employees of the clinic, investigators, or family members of the study staff.
  14. Patients who in the opinion of the Investigator would be non-compliant with the requirements of the study protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02978508
Other Study ID Numbers  ICMJE MAP-8184
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party bioRASI, LLC
Study Sponsor  ICMJE bioRASI, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Phoevos Hughes, JD bioRASI, LLC
PRS Account bioRASI, LLC
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP