Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis

A Randomized, Prospective, Multicenter, Double Blind, Parallel Assignment, Placebo Controlled Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® (Pimecrolimus) Cream, 1% in Patients With Mild to Moderate Atopic Dermatitis

To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis.

To establish superiority of each active treatment over the placebo.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Pimecrolimus Cream, 1%; Drug: Placebo Cream

• Study Type: Interventional
• Enrollment (Actual): 654
• Phase: Phase 3

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Research Facility 11
• Honduras
  • San Pedro Sula, Honduras
    • Research Facility 12
• United States
  • Florida
    • Boynton Beach, Florida, United States, 33437
      • Research Facility 6
    • Coral Gables, Florida, United States, 33146
      • Research Facility 4
    • Miami, Florida, United States, 33144
      • Research Facility 5
    • Miami, Florida, United States, 33175
      • Research Facility 10
    • Miami Lakes, Florida, United States, 33014
      • Research Facility 1
    • Miramar, Florida, United States, 33027
      • Research Facility 9
    • Sweetwater, Florida, United States, 33172
      • Research Facility 33
  • Idaho
    • Boise, Idaho, United States, 83704
      • Research Facility 23
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Research Facility 28
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Research Facility 32
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Research Facility 13
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Research Facility 7
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Research Facility 19
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Research Facility 29
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Research Facility 24
    • High Point, North Carolina, United States, 27262
      • Research Facility 2
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Resarch Facility 8
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Research Facility 18
  • Texas
    • Austin, Texas, United States, 78759
      • Research Facility 20
    • College Station, Texas, United States, 77845
      • Research Facility 16
    • Pflugerville, Texas, United States, 78660
      • Research Facility 31
    • Sugar Land, Texas, United States, 77479
      • Research Facility 17
  • Utah
    • West Jordan, Utah, United States, 84088
      • Research Facility 22
  • Virginia
    • Richmond, Virginia, United States, 23220
      • Research Facility 15
  • Washington
    • Spokane, Washington, United States, 99202
      • Research Facility 26

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non-immuno compromised male or female aged 8 years and older
• Clinical diagnosis of mild to moderate Atopic Dermatitis (AD)
• Failed to respond adequately to other topical prescription treatments for AD, or for whom those treatments are not advisable.
• A diagnosis of AD for at least 3 months
• An Investigator's Global Assessment (IGA) of disease severity of mild or moderate at baseline (score of 2 or 3)
• Affected area of AD involvement at least 5% body surface area (BSA)
• Treated with a bland emollient for at least 7 days

Exclusion Criteria:

• Females who are pregnant, breast feeding, or who wish to become pregnant during the study period
• Active cutaneous bacterial or viral infection in any treatment area at baseline (e.g., clinically infected atopic dermatitis, impetigo).
• Sunburn, extensive scarring or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations
• History or presence of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, ichthyosis, or scabies.
• History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders
• Concurrent disease or treatment likely to interfere with the study treatment or evaluations
• Known allergy or hypersensitivity to pimecrolimus or any other component of the drug products
• Not willing to minimize or avoid natural and artificial sunlight exposure during treatment

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: Test; Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days	Drug: Pimecrolimus Cream, 1%; Other Names: Elidel (pimecrolimus) Cream, 1%
Active Comparator: Reference Standard; Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days	Drug: Pimecrolimus Cream, 1%; Other Names: Elidel (pimecrolimus) Cream, 1%
Placebo Comparator: Placebo; Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days	Drug: Placebo Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])	Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting	Day 15
Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])	Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting	Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Severity of Four Individual Signs and Symptoms	Erythema, induration/papulation, lichenification and pruritus	Day 15
Evaluation of Application Site Reactions	Dryness, burning/stinging, erosion, edema, and pain	Day 15

Collaborators and Investigators

• Sponsor: Mylan Inc.
• Collaborators: DPT Laboratories, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2016
• Primary Completion (Actual): May 15, 2017
• Study Completion (Actual): May 15, 2017

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• 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: CD-14-875

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes