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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
654
Research Facility 6
Boynton Beach, Florida, United States
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])
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
Time frame: Day 15
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])
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
Time frame: Day 15
Change in Severity of Four Individual Signs and Symptoms
Erythema, induration/papulation, lichenification and pruritus
Time frame: Day 15
Evaluation of Application Site Reactions
Dryness, burning/stinging, erosion, edema, and pain
Time frame: Day 15
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Research Facility 4
Coral Gables, Florida, United States
Research Facility 5
Miami, Florida, United States
Research Facility 10
Miami, Florida, United States
Research Facility 1
Miami Lakes, Florida, United States
Research Facility 9
Miramar, Florida, United States
Research Facility 33
Sweetwater, Florida, United States
Research Facility 23
Boise, Idaho, United States
Research Facility 28
Overland Park, Kansas, United States
Research Facility 32
Louisville, Kentucky, United States
...and 17 more locations