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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2016
• Main ID: NCT02572986
• Date of registration: 08/10/2015
• Prospective Registration: No
• Primary sponsor: Dr. Reddy's Laboratories Limited
• Public title: A Study to Evaluate the Therapeutic Equivalence of Generic Permethrin Cream 5% to Elimite® in the Treatment of Scabies
• Scientific 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
• Date of first enrolment: September 2015
• Target sample size: 250
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02572986
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

El Salvador, Panama, United States

Contacts

• Name: Prasanna Ganapathi, MD
• Affiliation: Dr. Reddy's Laboratories Limited

• Name: Shilpi Dhawan, MD
• Affiliation: Dr. Reddy's Laboratories Limited

• Name: Ashis Patnaik, MD
• Affiliation: Dr. Reddy's Laboratories Limited

Key inclusion & exclusion 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.



Age minimum: 2 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Scabies

Intervention(s)

Drug: Permethrin

Primary Outcome(s)

Proportion of patients with therapeutic cure (parasitological cure plus clinical cure) of scabies [Time Frame: Day 28]

Secondary Outcome(s)

The proportion of patients with no itch persistence [Time Frame: Day 28]

Secondary ID(s)

DRL-USG02-P/2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novum Pharmaceutical Research Services