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

NCT02896101 | Completed Phase 3

• 1 other identifier: GLK-1601
• Study Type: interventional
• Target: 755
• Locations: 1 country
• Sites: 27

Brief Summary

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).

Conditions

Atopic Dermatitis

Keywords

Mild to moderate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

Pimecrolimus Cream, 1%

EXPERIMENTAL

Pimecrolimus Cream, 1 % (Glenmark Pharmaceuticals Ltd) topical application

Drug: Pimecrolimus Cream, 1%

Elidel®

ACTIVE COMPARATOR

Elidel® (Valeant Pharmaceuticals North America LLC) topical application

Drug: Elidel® (pimecrolimus) Cream

Placebo

PLACEBO COMPARATOR

Placebo of Pimecrolimus Cream, 1% (Glenmark Pharmaceuticals Ltd) topical application

Drug: Placebo of Pimecrolimus Cream, 1%

Interventions

Pimecrolimus Cream, 1% DRUG

Pimecrolimus Cream, 1%

Elidel® (pimecrolimus) Cream DRUG

Elidel®

Placebo of Pimecrolimus Cream, 1% DRUG

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glenmark Pharmaceuticals Ltd. India: lead

Study Sites (27)

Investigational Site 4

Hot Springs, Arkansas, United States

Location

Investigational Site 22

Little Rock, Arkansas, United States

Location

Investigational Site 20

Anaheim, California, United States

Location

Investigational Site 13

Fremont, California, United States

Location

Investigational Site 26

Norco, California, United States

Location

Investigational Site 17

Doral, Florida, United States

Location

Investigational Site 9

Hialeah, Florida, United States

Location

Investigational Site 16

Miami, Florida, United States

Location

Investigational Site 18

Miami, Florida, United States

Location

Investigational Site 19

Miami, Florida, United States

Location

Investigational Site 25

Miami, Florida, United States

Location

Investigational Site 8

Miami, Florida, United States

Location

Investigational Site 12

North Miami Beach, Florida, United States

Location

Investigational Site 3

Ormond Beach, Florida, United States

Location

Investigational Site 7

South Miami, Florida, United States

Location

Investigational Site 10

Tampa, Florida, United States

Location

Investigational Site 24

Tampa, Florida, United States

Location

Investigational Site 14

West Palm Beach, Florida, United States

Location

Investigational Site 1

Arlington Heights, Illinois, United States

Location

Investigational Site 21

Lake Charles, Louisiana, United States

Location

Investigational Site 2

Silver Spring, Maryland, United States

Location

Investigational Site 11

Saint Joseph, Missouri, United States

Location

Investigational Site 27

East Windsor, New Jersey, United States

Location

Investigational Site 5

High Point, North Carolina, United States

Location

Investigational Site 23

Raleigh, North Carolina, United States

Location

Investigational Site 15

Cincinnati, Ohio, United States

Location

Investigational Site 6

Nashville, Tennessee, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Dr. Nikhil Sawant

  Glenmark Pharmaceuticals Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 12, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

US (27)