A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies

Scabies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572986
• Other study ID #: DRL-USG02-P/2015
• Status: Completed
• Phase: Phase 3
• First received: October 8, 2015
• Last updated: October 13, 2016
• Start date: September 2015
• Est. completion date: August 2016

Study information

• Verified date: October 2015
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scabies

Intervention

Drug:
• Permethrin

Locations

Country	Name	City	State
El Salvador	Clinica Dermatologica	San Salvador
El Salvador	Clinica Dermatologica y Cirugia de Piel	Santa Tecla, La Libertad
Panama	Clinica Dermatologica Dra. Yariela Grajales	Ciudad de Panama	PanamaCity
United States	Sun Rise Clinical Research, Inc	Bell Gardens	California
United States	Derm Dx Center for Dermatology	Hazleton	Pennsylvania
United States	Solutions Through Advanced Research	Jacksonville	Florida
United States	L & C Professional Medical Research Institute	Miami	Florida
United States	San Marcus Research Clinic, Incorporation	Miami	Florida
United States	Vista Health Research, LLC	Miami	Florida
United States	Havana Research Institute	Pasadena	California
United States	Omni Dermatology	Phoenix	Arizona
United States	Zain Research, LLC	Richland	Washington
United States	Sun Research Institute	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited	Novum Pharmaceutical Research Services

Countries where clinical trial is conducted

United States,  El Salvador,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events assessment		Day 28	Yes
Primary	Proportion of patients with therapeutic cure (parasitological cure plus clinical cure) of scabies		Day 28	No
Secondary	The proportion of patients with no itch persistence		Day 28	No