Clinical trial NCT03178942: Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% in the Treatment of Scabies
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scabies
Lead sponsor: Encube Ethicals Pvt. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Novum Pharmaceutical Research Services
First posted: 2017-06-07
Enrollment: 254
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be assigned to the test or reference permethrin to treat scabies.
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Number of Patients in Each Treatment Group With Therapeutic Cure (Parasitological Cure Plus Clinical Cure) of Scabies
timeFrame: Day 28 ± 4
Secondary outcomes:
Other outcomes:
measure: Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days.
timeFrame: Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days
measure: 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.
timeFrame: Visit 2 within 14 ± 2 days and Visit 3 between Day 26 and Day 32, inclusive.
measure: Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days.
timeFrame: Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days
Locations:
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Anaheim
country: United States
facility: St. Josephs Clinical Research
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials
state: California
city: Pasadena
country: United States
facility: Havana Research Institute
state: California
city: Hialeah
country: United States
facility: Integrity Clinical Research Center, Inc.
state: Florida
city: Kissimmee
country: United States
facility: The Chappel Group Research
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group, LLC
state: Florida
city: Hazleton
country: United States
facility: DermDox Cetners for Dermatology
state: Pennsylvania
city: Houston
country: United States
facility: West Houston Clinical Research Services
state: Texas
city: San Antonio
country: United States
facility: Sun Research Instiute
state: Texas
city: San Salvador
country: El Salvador
facility: Clinica Dermatologica/APF Research International
city: San Salvador
country: El Salvador
facility: Clinica Dermatologica Y Cirugia de Piel/APF Research International
city: San Salvador
country: El Salvador
facility: Clinica de la Doctora Laura Vargas
city: Aguas Buenas
country: Puerto Rico
facility: APF Research International
city: Loiza
country: Puerto Rico
facility: APF Research International
Study officials:
affiliation: Encube Ethicals Pvt. Ltd.
name: Pratik Kamani
role: STUDY_DIRECTOR
References: