Clinical trial NCT02572986: A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® 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% to Elimite™ Cream 5% in the Treatment of Scabies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scabies
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
Collaborators: name: Novum Pharmaceutical Research Services
First posted: 2015-10-09
Enrollment: 250
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Proportion of patients with therapeutic cure (parasitological cure plus clinical cure) of scabies
timeFrame: Day 28
Secondary outcomes:
measure: The proportion of patients with no itch persistence
timeFrame: Day 28
Other outcomes:
measure: Adverse events assessment
timeFrame: Day 28
Locations:
city: Phoenix
country: United States
facility: Omni Dermatology
state: Arizona
city: Bell Gardens
country: United States
facility: Sun Rise Clinical Research, Inc
state: California
city: Pasadena
country: United States
facility: Havana Research Institute
state: California
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic, Incorporation
state: Florida
city: Miami
country: United States
facility: L & C Professional Medical Research Institute
state: Florida
city: Miami
country: United States
facility: Vista Health Research, LLC
state: Florida
city: Hazleton
country: United States
facility: Derm Dx Center for Dermatology
state: Pennsylvania
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Richland
country: United States
facility: Zain Research, LLC
state: Washington
city: San Salvador
country: El Salvador
facility: Clinica Dermatologica
city: Santa Tecla, La Libertad
country: El Salvador
facility: Clinica Dermatologica y Cirugia de Piel
city: Ciudad de Panama
country: Panama
facility: Clinica Dermatologica Dra. Yariela Grajales
state: PanamaCity
Study officials:
affiliation: Dr. Reddy's Laboratories Limited
name: Ashis Patnaik, MD
role: STUDY_DIRECTOR
affiliation: Dr. Reddy's Laboratories Limited
name: Prasanna Ganapathi, MD
role: STUDY_DIRECTOR
affiliation: Dr. Reddy's Laboratories Limited
name: Shilpi Dhawan, MD
role: STUDY_DIRECTOR
References: