To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064%, in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis).

Last updated: August 17, 2020
Sponsor: Glenmark Pharmaceuticals Ltd. India
Overall Status: Completed

Phase

3

Condition

Psoriasis And Psoriatic Disorders

Warts

Scalp Disorders

Treatment

N/A

Clinical Study ID

NCT03731091
GLK-1801
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Enstilar® Foam (LEO Pharma Inc.) in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or non-pregnant, non-lactating female subjects aged at least 18 years at Visit 1.

  2. A clinical diagnosis of stable (at least 6 months) psoriasis vulgaris involving 5% to 30% body surface area (BSA), not including the face, axilla and groin.

  3. A PGA of disease severity of at least moderate disease severity (Grade ≥ 3).

  4. A plaque elevation of at least moderate severity (Grade ≥ 3) at the target lesionsite. The most severe lesion at baseline should be identified as the target lesion.

  5. Provide written informed consent. -

Exclusion

Exclusion Criteria:

  1. Current diagnosis of unstable forms of psoriasis in the treatment area includingguttate, erythrodermic, exfoliative, or pustular psoriasis.

  2. Other inflammatory skin disease in the treatment area that may confound the evaluationof the psoriasis vulgaris (e.g., atopic dermatitis, contact dermatitis, tineacorporis).

  3. Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in thetreatment areas that could interfere with the rating of efficacy parameters.

  4. History of psoriasis unresponsive to topical treatments.

  5. History of hypersensitivity to any component of the Test or Reference product.

  6. Current or past history of hypercalcemia, calcium metabolism disorder, vitamin Dtoxicity, severe renal insufficiency, or severe hepatic disorders.

  7. Current immunosuppression.

  8. Use within 6 months prior to baseline of biologic treatment for psoriasis (e.g.,infliximab, adalimumab, alefacept).

  9. Use within 3 months prior to baseline of: 1) chemotherapy or 2) radiation therapy.

  10. Use within 2 months prior to baseline of: 1) immunosuppressive drugs (e.g.,tacrolimus, pimecrolimus) or 2) oral retinoids.

  11. Use within 1 month prior to baseline of: 1) systemic steroids, 2) systemicantibiotics, 3) other systemic antipsoriatic treatment, 4) psoralen and ultraviolet A (PUVA) therapy, 5) ultraviolet B (UVB) therapy, or 6) systemic anti-inflammatoryagents. Note: a) Non-steroidal anti-inflammatory drugs (NSAIDs) and aspirin use on anas-needed basis and if not used consecutively for > 14 days prior to baseline and/orduring the study is acceptable. Low-dose (81 mg) aspirin taken daily is acceptable. b)Intranasal or inhaled corticosteroids are acceptable if kept constant throughout thestudy. Intra-articular steroid injections are permissible.

  12. Use within 2 weeks prior to baseline of: 1) topical antipsoriatic drugs (e.g.,salicylic acid, anthralin, coal tar, calcipotriene, tazarotene), 2) topicalcorticosteroids, or 3) topical retinoids.

  13. Use within 2 weeks prior to baseline of: 1) vitamin D supplements 2) vitamin D analogsat a dose >400 IU/day; or 3) calcium supplements (including multivitamins containingcalcium).

  14. Started beta-blocker therapy, antimalarial products, and/or lithium within 3 months ofbaseline. Subjects who have been on a steady dose for at least 3 months prior tobaseline and will remain on the same dose throughout the study are eligible for studyparticipation.

  15. Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVBduring the study.

Study Design

Total Participants: 494
Study Start date:
October 31, 2018
Estimated Completion Date:
March 17, 2020

Connect with a study center

  • Investigational Site 20

    Encinitas, California 92024
    United States

    Site Not Available

  • Investigational Site 18

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Investigational Site 15

    San Diego, California 92123
    United States

    Site Not Available

  • Investigational Site 19

    San Diego, California 92108
    United States

    Site Not Available

  • Investigational Site 23

    San Diego, California 92123
    United States

    Site Not Available

  • Investigational Site 17

    Santa Ana, California 92705
    United States

    Site Not Available

  • Investigational Site 22

    Santa Monica, California 90404
    United States

    Site Not Available

  • Investigational Site 29

    Clearwater, Florida 33761
    United States

    Site Not Available

  • Investigational Site 27

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Investigational Site 1

    Miami, Florida 33144
    United States

    Site Not Available

  • Investigational Site 26

    Pinellas Park, Florida 33781
    United States

    Site Not Available

  • Investigational Site 9

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Investigational Site 10

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Investigational Site 3

    Overland Park, Kansas 66215
    United States

    Site Not Available

  • Investigational Site 16

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Investigational Site 21

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Investigational Site 12

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Investigational Site 28

    New York, New York 10019
    United States

    Site Not Available

  • Investigational Site 4

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Investigational Site 24

    Wilmington, North Carolina 28405
    United States

    Site Not Available

  • Investigational Site 8

    Beachwood, Ohio 44122
    United States

    Site Not Available

  • Investigational Site 2

    Cincinnati, Ohio 45246
    United States

    Site Not Available

  • Investigational Site 13

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Investigational Site 7

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Investigational site 31

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Investigational Site 25

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • Investigational Site 5

    Austin, Texas 78759
    United States

    Site Not Available

  • Investigational Site 11

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Investigational Site 14

    San Antonio, Texas 78249
    United States

    Site Not Available

  • Investigational Site 30

    Webster, Texas 77598
    United States

    Site Not Available

  • Investigational Site 6

    Norfolk, Virginia 23507
    United States

    Site Not Available

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