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Search / Trial NCT02896101

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

Mild To Moderate

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.

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

0 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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