Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791308
• Other study ID #: SYM 2014-03
• Status: Completed
• Phase: Phase 3
• Start date: February 2015
• Est. completion date: July 2016

Study information

• Verified date: May 2020
• Source: Actavis Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 587
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Pimecrolimus Cream 1% (Valeant)

• Vehicle cream

• Pimecrolimus Cream, 1%

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Actavis Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Treatment Success at Visit 4/Day 15	Percentage of subjects in each treatment group with treatment success, defined as a grade of clear or almost clear (a score of 0 or 1 on the IGA) within all treatment areas at the end of treatment on Visit 4/Day 15	15 days