Study of Generic Pimecrolimus Cream, 1% in the Treatment of Mild to Moderate Atopic Dermatitis

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (Pimecrolimus) Cream, 1% (Valeant Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis (AD).

This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) to the Marketed Product ELIDEL® (pimecrolimus) Cream, 1% (Valeant Pharmaceuticals North America LLC) in the Treatment of Mild to Moderate Atopic Dermatitis (AD).

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Pimecrolimus Cream, 1%; Drug: Elidel® (pimecrolimus) Cream; Drug: Placebo of Pimecrolimus Cream, 1%

• Study Type: Interventional
• Enrollment (Actual): 755
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States
      • Investigational site 4
    • Little Rock, Arkansas, United States
      • Investigational site 22
  • California
    • Anaheim, California, United States
      • Investigational site 20
    • Fremont, California, United States
      • Investigational site 13
    • Norco, California, United States
      • Investigational site 26
  • Florida
    • Doral, Florida, United States
      • Investigational site 17
    • Hialeah, Florida, United States
      • Investigational site 9
    • Miami, Florida, United States
      • Investigational Site 16
    • Miami, Florida, United States
      • Investigational site 18
    • Miami, Florida, United States
      • Investigational site 19
    • Miami, Florida, United States
      • Investigational site 25
    • Miami, Florida, United States
      • Investigational site 8
    • North Miami Beach, Florida, United States
      • Investigational site 12
    • Ormond Beach, Florida, United States
      • Investigational site 3
    • South Miami, Florida, United States
      • Investigational site 7
    • Tampa, Florida, United States
      • Investigational site 10
    • Tampa, Florida, United States
      • Investigational site 24
    • West Palm Beach, Florida, United States
      • Investigational site 14
  • Illinois
    • Arlington Heights, Illinois, United States
      • Investigational site 1
  • Louisiana
    • Lake Charles, Louisiana, United States
      • Investigational site 21
  • Maryland
    • Silver Spring, Maryland, United States
      • Investigational site 2
  • Missouri
    • Saint Joseph, Missouri, United States
      • Investigational site 11
  • New Jersey
    • East Windsor, New Jersey, United States
      • Investigational site 27
  • North Carolina
    • High Point, North Carolina, United States
      • Investigational site 5
    • Raleigh, North Carolina, United States
      • Investigational site 23
  • Ohio
    • Cincinnati, Ohio, United States
      • Investigational site 15
  • Tennessee
    • Nashville, Tennessee, United States
      • Investigational site 6

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or non-pregnant, non-lactating female subjects 12 years of age and older.
• Non-immunocompromised, with a clinical diagnosis of mild to moderate AD that has failed to respond adequately to other topical prescription treatments for atopic dermatitis, or for whom those treatments are not advisable.
• Confirmed diagnosis of AD for at least 3 months using the diagnostic features as described by Hanifin and Rajka.
• IGA score of 2 (mild) or 3 (moderate) and ≥ 5% BSA affected at baseline.

Exclusion Criteria:

• Active cutaneous bacterial, viral or fungal infection in any treatment area at baseline (e.g., clinically infected AD).
• Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline and history or presence of skin conditions that would interfere with evaluations.
• History or presence of Netherton's Syndrome, immunological deficiencies or diseases, organ transplant, HIV, diabetes, malignancy, malignant or pre-malignant skin conditions, serious active or recurrent infection, systemic immunosuppressive regimens, clinically significant severe renal insufficiency or severe hepatic disorders.
• Use within one month before baseline of 1) oral or intravenous corticosteroids, 2) UVA/UVB therapy, 3) psoralen plus ultraviolet A therapy (PUVA), 4) tanning booths, 5) non-prescription ultraviolet (UV) light sources, 6) immunomodulators or immunosuppressive therapies, 7) interferon, 8) cytotoxic drugs, 9) tacrolimus or 10) pimecrolimus.
• Use within 14 days before baseline of: 1) systemic antibiotics, 2) calcipotriene or other vitamin D preparations, or 3) retinoids.
• Use within 7 days before baseline of: 1) antihistamines, 2) topical antibiotics, 3) topical corticosteroids or 4) other topical drug products.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pimecrolimus Cream, 1%; Pimecrolimus Cream, 1 % (Glenmark Pharmaceuticals Ltd) topical application	Drug: Pimecrolimus Cream, 1%
Active Comparator: Elidel®; Elidel® (Valeant Pharmaceuticals North America LLC) topical application	Drug: Elidel® (pimecrolimus) Cream
Placebo Comparator: Placebo; Placebo of Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) topical application	Drug: Placebo of Pimecrolimus Cream, 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects in each treatment group with treatment success (i.e., a grade of clear or almost clear; a score of 0 or 1, within the treatment area) based on the IGA of Disease Severity at the end of treatment (Visit 3; Day 15 ± 3).	Day 15

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in severity score from baseline to Visit 3 of the four individual signs and symptoms of AD (i.e., erythema, induration/papulation, lichenification and pruritus).	Day 15

Collaborators and Investigators

• Sponsor: Glenmark Pharmaceuticals Ltd. India
• Investigators: Study Director: Dr. Nikhil Sawant, Glenmark Pharmaceuticals Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: September 6, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Mild to moderate
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Calcineurin Inhibitors; Tacrolimus; Pimecrolimus
• Other Study ID Numbers: GLK-1601