Study of Generic Pimecrolimus Cream, 1% in the Treatment of Mild to Moderate Atopic Dermatitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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).

Key facts

Study ID

NCT02896101

Run by

Glenmark Pharmaceuticals Ltd. India

People needed

755

Starts

2016-08-01

Expected to finish

2017-06-01

Last updated by the study team

2019-07-31

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site 4 — Hot Springs, Arkansas, United States
• Investigational Site 22 — Little Rock, Arkansas, United States
• Investigational Site 20 — Anaheim, California, United States
• Investigational Site 13 — Fremont, California, United States
• Investigational Site 26 — Norco, California, United States
• Investigational Site 17 — Doral, Florida, United States
• Investigational Site 9 — Hialeah, Florida, United States
• Investigational Site 16 — Miami, Florida, United States
• Investigational Site 18 — Miami, Florida, United States
• Investigational Site 19 — Miami, Florida, United States
• Investigational Site 25 — Miami, Florida, United States
• Investigational Site 8 — Miami, Florida, United States
• Investigational Site 12 — North Miami Beach, Florida, United States
• Investigational Site 3 — Ormond Beach, Florida, United States
• Investigational Site 7 — South Miami, Florida, United States
• Investigational Site 10 — Tampa, Florida, United States
• Investigational Site 24 — Tampa, Florida, United States
• Investigational Site 14 — West Palm Beach, Florida, United States
• Investigational Site 1 — Arlington Heights, Illinois, United States
• Investigational Site 21 — Lake Charles, Louisiana, United States
• Investigational Site 2 — Silver Spring, Maryland, United States
• Investigational Site 11 — Saint Joseph, Missouri, United States
• Investigational Site 27 — East Windsor, New Jersey, United States
• Investigational Site 5 — High Point, North Carolina, United States
• Investigational Site 23 — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.