Study of Generic Pimecrolimus Cream, 1% in the Treatment of Mild to Moderate Atopic Dermatitis
Launched by GLENMARK PHARMACEUTICALS LTD. INDIA · Sep 9, 2016
Trial Information
Current as of May 03, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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.
About Glenmark Pharmaceuticals Ltd. India
Glenmark Pharmaceuticals Ltd. is a global research-driven pharmaceutical company based in India, committed to improving patient outcomes through innovative healthcare solutions. Established in 1977, Glenmark specializes in the development, manufacturing, and marketing of a diverse range of branded and generic pharmaceuticals, as well as active pharmaceutical ingredients (APIs). With a strong focus on research and development, the company invests significantly in discovering novel therapies across various therapeutic areas, including oncology, respiratory, and dermatology. Glenmark's commitment to clinical excellence and patient-centric approach positions it as a key player in the global pharmaceutical landscape, dedicated to advancing healthcare through high-quality, cost-effective medicines.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hot Springs, Arkansas, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Fremont, California, United States
Norco, California, United States
Doral, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
Ormond Beach, Florida, United States
South Miami, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Arlington Heights, Illinois, United States
Lake Charles, Louisiana, United States
Silver Spring, Maryland, United States
Saint Joseph, Missouri, United States
East Windsor, New Jersey, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Nashville, Tennessee, United States
Patients applied
Trial Officials
Dr. Nikhil Sawant
Study Director
Glenmark Pharmaceuticals Ltd.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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