Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: Placebo Cream
- Registration Number
- NCT03107611
- Lead Sponsor
- Mylan Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 654
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Cream Placebo cream, topical, thin layer applied to all affected skin areas twice daily for 14 days Reference Standard Pimecrolimus Cream, 1% Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days Test Pimecrolimus Cream, 1% Pimecrolimus Cream, 1%, topical, thin layer applied to all affected skin areas twice daily for 14 days
- Primary Outcome Measures
Name Time Method 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]) Day 15 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]) Day 15 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
Name Time Method Change in Severity of Four Individual Signs and Symptoms Day 15 Erythema, induration/papulation, lichenification and pruritus
Evaluation of Application Site Reactions Day 15 Dryness, burning/stinging, erosion, edema, and pain
Trial Locations
- Locations (27)
Research Facility 28
🇺🇸Overland Park, Kansas, United States
Research Facility 1
🇺🇸Miami Lakes, Florida, United States
Research Facility 6
🇺🇸Boynton Beach, Florida, United States
Research Facility 4
🇺🇸Coral Gables, Florida, United States
Research Facility 5
🇺🇸Miami, Florida, United States
Research Facility 9
🇺🇸Miramar, Florida, United States
Research Facility 33
🇺🇸Sweetwater, Florida, United States
Research Facility 13
🇺🇸New Orleans, Louisiana, United States
Research Facility 24
🇺🇸Charlotte, North Carolina, United States
Research Facility 7
🇺🇸Saint Joseph, Missouri, United States
Research Facility 29
🇺🇸Albuquerque, New Mexico, United States
Research Facility 2
🇺🇸High Point, North Carolina, United States
Resarch Facility 8
🇺🇸Philadelphia, Pennsylvania, United States
Research Facility 18
🇺🇸Johnston, Rhode Island, United States
Research Facility 20
🇺🇸Austin, Texas, United States
Research Facility 16
🇺🇸College Station, Texas, United States
Research Facility 17
🇺🇸Sugar Land, Texas, United States
Research Facility 22
🇺🇸West Jordan, Utah, United States
Research Facility 31
🇺🇸Pflugerville, Texas, United States
Research Facility 11
🇩🇴Santo Domingo, Dominican Republic
Research Facility 15
🇺🇸Richmond, Virginia, United States
Research Facility 26
🇺🇸Spokane, Washington, United States
Research Facility 12
🇭🇳San Pedro Sula, Honduras
Research Facility 10
🇺🇸Miami, Florida, United States
Research Facility 23
🇺🇸Boise, Idaho, United States
Research Facility 32
🇺🇸Louisville, Kentucky, United States
Research Facility 19
🇺🇸Omaha, Nebraska, United States