Clinical trial NCT03107611: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: DPT Laboratories, Ltd.
First posted: 2017-04-11
Enrollment: 654
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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])
timeFrame: Day 15
measure: 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])
timeFrame: Day 15
Secondary outcomes:
measure: Change in Severity of Four Individual Signs and Symptoms
timeFrame: Day 15
measure: Evaluation of Application Site Reactions
timeFrame: Day 15
Other outcomes:
Locations:
city: Boynton Beach
country: United States
facility: Research Facility 6
state: Florida
city: Coral Gables
country: United States
facility: Research Facility 4
state: Florida
city: Miami Lakes
country: United States
facility: Research Facility 1
state: Florida
city: Miami
country: United States
facility: Research Facility 5
state: Florida
city: Miami
country: United States
facility: Research Facility 10
state: Florida
city: Miramar
country: United States
facility: Research Facility 9
state: Florida
city: Sweetwater
country: United States
facility: Research Facility 33
state: Florida
city: Boise
country: United States
facility: Research Facility 23
state: Idaho
city: Overland Park
country: United States
facility: Research Facility 28
state: Kansas
city: Louisville
country: United States
facility: Research Facility 32
state: Kentucky
city: New Orleans
country: United States
facility: Research Facility 13
state: Louisiana
city: Saint Joseph
country: United States
facility: Research Facility 7
state: Missouri
city: Omaha
country: United States
facility: Research Facility 19
state: Nebraska
city: Albuquerque
country: United States
facility: Research Facility 29
state: New Mexico
city: Charlotte
country: United States
facility: Research Facility 24
state: North Carolina
city: High Point
country: United States
facility: Research Facility 2
state: North Carolina
city: Philadelphia
country: United States
facility: Resarch Facility 8
state: Pennsylvania
city: Johnston
country: United States
facility: Research Facility 18
state: Rhode Island
city: Austin
country: United States
facility: Research Facility 20
state: Texas
city: College Station
country: United States
facility: Research Facility 16
state: Texas
city: Pflugerville
country: United States
facility: Research Facility 31
state: Texas
city: Sugar Land
country: United States
facility: Research Facility 17
state: Texas
city: West Jordan
country: United States
facility: Research Facility 22
state: Utah
city: Richmond
country: United States
facility: Research Facility 15
state: Virginia
city: Spokane
country: United States
facility: Research Facility 26
state: Washington
city: Santo Domingo
country: Dominican Republic
facility: Research Facility 11
city: San Pedro Sula
country: Honduras
facility: Research Facility 12
Study officials:
References: