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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pimecrolimus Cream, 1%
Placebo Cream
Pimecrolimus Cream, 1%
Sponsored by
Mylan Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Facility 6
  • Research Facility 4
  • Research Facility 1
  • Research Facility 5
  • Research Facility 10
  • Research Facility 9
  • Research Facility 33
  • Research Facility 23
  • Research Facility 28
  • Research Facility 32
  • Research Facility 13
  • Research Facility 7
  • Research Facility 19
  • Research Facility 29
  • Research Facility 24
  • Research Facility 2
  • Resarch Facility 8
  • Research Facility 18
  • Research Facility 20
  • Research Facility 16
  • Research Facility 31
  • Research Facility 17
  • Research Facility 22
  • Research Facility 15
  • Research Facility 26
  • Research Facility 11
  • Research Facility 12

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Test

Reference Standard

Placebo

Arm Description

Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days

Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days

Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Change in Severity of Four Individual Signs and Symptoms
Erythema, induration/papulation, lichenification and pruritus
Evaluation of Application Site Reactions
Dryness, burning/stinging, erosion, edema, and pain

Full Information

First Posted
April 5, 2017
Last Updated
March 3, 2022
Sponsor
Mylan Inc.
Collaborators
DPT Laboratories, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03107611
Brief Title
Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 29, 2016 (Actual)
Primary Completion Date
May 15, 2017 (Actual)
Study Completion Date
May 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mylan Inc.
Collaborators
DPT Laboratories, Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
654 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Arm Title
Reference Standard
Arm Type
Active Comparator
Arm Description
Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus Cream, 1%
Intervention Type
Drug
Intervention Name(s)
Placebo Cream
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus Cream, 1%
Other Intervention Name(s)
Elidel (pimecrolimus) Cream, 1%
Primary Outcome Measure Information:
Title
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])
Description
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
Time Frame
Day 15
Title
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])
Description
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
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Change in Severity of Four Individual Signs and Symptoms
Description
Erythema, induration/papulation, lichenification and pruritus
Time Frame
Day 15
Title
Evaluation of Application Site Reactions
Description
Dryness, burning/stinging, erosion, edema, and pain
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Research Facility 6
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Research Facility 4
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Research Facility 1
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Research Facility 5
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Research Facility 10
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Research Facility 9
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Research Facility 33
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Research Facility 23
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Research Facility 28
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Research Facility 32
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Research Facility 13
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Research Facility 7
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Research Facility 19
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Research Facility 29
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Research Facility 24
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Research Facility 2
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Resarch Facility 8
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Research Facility 18
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Research Facility 20
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Research Facility 16
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Research Facility 31
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Research Facility 17
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Research Facility 22
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Research Facility 15
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States
Facility Name
Research Facility 26
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Research Facility 11
City
Santo Domingo
Country
Dominican Republic
Facility Name
Research Facility 12
City
San Pedro Sula
Country
Honduras

12. IPD Sharing Statement

Learn more about this trial

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

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