Clinical trial NCT02791308: Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis
Official title: Double-Blind Randomized Vehicle Controlled Study Evaluating Safety and Bioequivalence of Generic Pimecrolimus Cream 1% and Elidel® Comparing Both Active Treatments to a Vehicle Control in Treatment of Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Actavis Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-06
Enrollment: 587
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and efficacy profiles of Watson Laboratories, Inc.'s Pimecrolimus Cream, 1% to those of Valeant Pharmaceuticals North America LLC's Elidel® (pimecrolimus) Cream, 1%, and to demonstrate the superior efficacy of the two active creams over that of the placebo (Vehicle of test product), in the treatment of mild to moderate atopic dermatitis.

Detailed description: Pimecrolimus cream, 1% is a calcineurin inhibitor immunosuppressant. Pimecrolimus inhibits T cell activation by blocking the transcription of early cytokines. Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. This study is being conducted to evaluate the clinical bioequivalence of sponsor's formulation of Pimecrolimus Cream, 1%, the Test product, and Elidel Cream, 1%, the Reference product. A vehicle control arm is included to demonstrate that the Test and Reference products are active and to establish that the study is sufficiently sensitive to detect differences between products.

Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent/assent for the study.
* Non-immunocompromised male or female aged 12 years or older.
* A clinical diagnosis of mild to moderate atopic dermatitis that has failed to respond adequately to other topical prescription treatments for atopic dermatitis, or subjects for whom the use of those other treatments is deemed inadvisable.
* A diagnosis of atopic dermatitis for at least 3 months.
* A baseline Investigator's Global Assessment (IGA) of disease severity of mild or moderate (score of 2 or 3).
* An affected area of atopic dermatitis involvement of at least 5% of the body surface area (BSA) at Visit 2/Day 1 (Baseline), as defined by the criteria of Hanifin and Rajka (1980).
* Treatment with a bland emollient for at least 7 days prior to Visit 2/Day 1 (Baseline).
* Agree to adhere to protocol-specified requirements and concomitant therapy restrictions.
* Willing to avoid constant sun exposure and the use of tanning booths or other UV light sources during participation in the study.
* In general good health, non-immunocompromised, and free from any clinically significant disease, other than atopic dermatitis, that might interfere with the study evaluations.
* Willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, return for the required study visits, comply with therapy prohibitions, and complete the study.
* Female subjects of childbearing potential (excluding women who are surgically sterilized \[hysterectomy, bilateral tubal ligation, or bilateral ovariectomy\] or have been postmenopausal for at least 1 year) must have a negative urine pregnancy test and must be willing to use a medically accepted method of contraception during the study. The following are considered acceptable methods of birth control for the purpose of this study: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double barrier methods (e.g., condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), Essure® permanent birth control, and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active. Subjects entering the study who are on hormonal contraceptives must have been on the method for at least 90 days prior to the study and continue the method for the duration of the study. Subjects who had used hormonal contraception and stopped must have stopped no less than 90 days prior to Visit 1.

Exclusion Criteria:

* Females who were pregnant, breastfeeding, intending to become pregnant during the study, or who did not agree to use an acceptable form of birth control during the study.
* Active cutaneous bacterial or viral infection in any proposed treatment area at Visit 2/Baseline (e.g., clinically infected atopic dermatitis).
* Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at Visit 2/Baseline that would interfere with the study evaluations.
* History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis.
* 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.
* Use of any treatment listed in Table 9.1 more recently than the indicated washout period prior to Visit 2/Baseline.
* Need or intent to continue to use any treatment listed in Table 9.1 during the current study.

Primary outcomes:
measure: Percentage of Subjects With Treatment Success at Visit 4/Day 15
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama
state: Alabama
city: Mesa
country: United States
facility: Agave Clinical Research, LLC
state: Arizona
city: Phoenix
country: United States
facility: Omni Dermatology/Physicians Research Group, LLC
state: Arizona
city: Rogers
country: United States
facility: Northwest Arkansas Clinical Trials Center, PLLC
state: Arkansas
city: Fountain Valley
country: United States
facility: MD Studies, Inc.
state: California
city: Laguna Hills
country: United States
facility: Alliance Research Centers
state: California
city: San Diego
country: United States
facility: Medical Center for Clinical Research
state: California
city: San Diego
country: United States
facility: Skin Surgery Medical Group, Inc.
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Ctr., LLC
state: Colorado
city: Thornton
country: United States
facility: Immunoe International Research Centers
state: Colorado
city: Boca Raton
country: United States
facility: Dermatology of Boca
state: Florida
city: Clearwater
country: United States
facility: Olympian Clinical Research
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research, Inc.
state: Florida
city: Sanford
country: United States
facility: International Clinical Research- US, LLC
state: Florida
city: Tampa
country: United States
facility: MOORE Clinical Research, Inc.
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Overland Park
country: United States
facility: Kansas City Dermatology PA
state: Kansas
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Louisville
country: United States
facility: Dermatology Specialists Research
state: Kentucky
city: Glenn Dale
country: United States
facility: Callender Center for Clinical Research, LLC
state: Maryland
city: Ann Arbor
country: United States
facility: David Fivenson, MD, PLC
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research Inc.
state: Nebraska
city: Henderson
country: United States
facility: Karl G. Heine, MD Dermatology
state: Nevada
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: New York
country: United States
facility: Pinkas E. Lebovits, MD, PC
state: New York
city: Charlotte
country: United States
facility: Piedmont Plastic Surgery and Dermatology
state: North Carolina
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Portland
country: United States
facility: Baker Allergy, Asthma and Dermatology Research Center, LLC
state: Oregon
city: Upland
country: United States
facility: Asthma & Allergy Research Associates
state: Pennsylvania
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Greenville
country: United States
facility: Greenville Dermatology
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, P.A./The Center for Skin Research
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Katy
country: United States
facility: Suzanne Bruce and Associates, P.A., The Center for Skin Research
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: Pflugerville
country: United States
facility: Pflugerville Dermatology Clinical Research Center, Inc.
state: Texas
city: Plano
country: United States
facility: ACRC Trials
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Draper
country: United States
facility: Intermountain Clinical Research
state: Utah
city: Lynchburg
country: United States
facility: The Education and Research Foundation, Inc.
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research-Richmond, Inc.
state: Virginia
city: Seattle
country: United States
facility: Dermatology Associates
state: Washington
city: Walla Walla
country: United States
facility: Eastern Washington Dermatology
state: Washington
Study officials:
affiliation: Senior Clinical Project Manager
name: Beth Landis
role: STUDY_DIRECTOR
References: