Clinical trial NCT02896101: Study of Generic Pimecrolimus Cream, 1% in the Treatment of Mild to Moderate Atopic Dermatitis
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Mild to moderate
Lead sponsor: Glenmark Pharmaceuticals Ltd. India
Sponsor class: INDUSTRY
First posted: 2016-09-12
Enrollment: 755
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: Day 15
Secondary outcomes:
measure: 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).
timeFrame: Day 15
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Investigational Site 4
state: Arkansas
city: Little Rock
country: United States
facility: Investigational Site 22
state: Arkansas
city: Anaheim
country: United States
facility: Investigational Site 20
state: California
city: Fremont
country: United States
facility: Investigational Site 13
state: California
city: Norco
country: United States
facility: Investigational Site 26
state: California
city: Doral
country: United States
facility: Investigational Site 17
state: Florida
city: Hialeah
country: United States
facility: Investigational Site 9
state: Florida
city: Miami
country: United States
facility: Investigational Site 16
state: Florida
city: Miami
country: United States
facility: Investigational Site 18
state: Florida
city: Miami
country: United States
facility: Investigational Site 19
state: Florida
city: Miami
country: United States
facility: Investigational Site 25
state: Florida
city: Miami
country: United States
facility: Investigational Site 8
state: Florida
city: North Miami Beach
country: United States
facility: Investigational Site 12
state: Florida
city: Ormond Beach
country: United States
facility: Investigational Site 3
state: Florida
city: South Miami
country: United States
facility: Investigational Site 7
state: Florida
city: Tampa
country: United States
facility: Investigational Site 10
state: Florida
city: Tampa
country: United States
facility: Investigational Site 24
state: Florida
city: West Palm Beach
country: United States
facility: Investigational Site 14
state: Florida
city: Arlington Heights
country: United States
facility: Investigational Site 1
state: Illinois
city: Lake Charles
country: United States
facility: Investigational Site 21
state: Louisiana
city: Silver Spring
country: United States
facility: Investigational Site 2
state: Maryland
city: Saint Joseph
country: United States
facility: Investigational Site 11
state: Missouri
city: East Windsor
country: United States
facility: Investigational Site 27
state: New Jersey
city: High Point
country: United States
facility: Investigational Site 5
state: North Carolina
city: Raleigh
country: United States
facility: Investigational Site 23
state: North Carolina
city: Cincinnati
country: United States
facility: Investigational Site 15
state: Ohio
city: Nashville
country: United States
facility: Investigational Site 6
state: Tennessee
Study officials:
affiliation: Glenmark Pharmaceuticals Ltd.
name: Dr. Nikhil Sawant
role: STUDY_DIRECTOR
References: