To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp Psoriasis

Last updated: December 20, 2018
Sponsor: Glenmark Pharmaceuticals Ltd. India
Overall Status: Completed

Phase

3

Condition

Psoriasis And Psoriatic Disorders

Rosacea

Scalp Disorders

Treatment

N/A

Clinical Study ID

NCT03331523
GLK-1701
  • Ages > 18
  • All Genders

Study Summary

This is a phase III, randomized, double-blind, placebo-controlled, parallel- group, multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. in the treatment of scalp 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) scalp psoriasis involving at least 10% of the scalp and clinical signs of psoriasis vulgaris on trunk and/or limbs.

  3. A PGA of disease severity of the scalp psoriasis consistent with at least moderatedisease severity (Grade ≥ 3).

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

Exclusion

Exclusion Criteria:

  1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic,exfoliative, or pustular psoriasis.

  2. Other inflammatory skin disease in the scalp that may confound the evaluation of thescalp psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea capitis).

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

  4. Presence of viral lesions, fungal, bacterial, or parasitic infections and/or atrophic (thinning) skin on the scalp.

  5. History of psoriasis unresponsive to topical treatments.

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

Study Design

Total Participants: 643
Study Start date:
October 20, 2017
Estimated Completion Date:
October 25, 2018

Connect with a study center

  • Investigational Site 24

    Encinitas, California 92024
    United States

    Site Not Available

  • Investigational Site 3

    Fremont, California 94538
    United States

    Site Not Available

  • Investigational Site 13

    San Diego, California 92108
    United States

    Site Not Available

  • Investigational Site 20

    San Diego, California 92123
    United States

    Site Not Available

  • Investigational Site 32

    Santa Monica, California 90404
    United States

    Site Not Available

  • Investigational Site 14

    Denver, Colorado 80220
    United States

    Site Not Available

  • Investigational Site 1

    Miami, Florida 33144
    United States

    Site Not Available

  • Investigational Site 30

    Miami, Florida 33175
    United States

    Site Not Available

  • Investigational Site 7

    Miramar, Florida 33027
    United States

    Site Not Available

  • Investigational Site 22

    Tampa, Florida 33609
    United States

    Site Not Available

  • Investigational Site 15

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Investigational Site 10

    South Bend, Indiana 46617
    United States

    Site Not Available

  • Investigational Site 21

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Investigational Site 2

    Glenn Dale, Maryland 20769
    United States

    Site Not Available

  • Investigational Site 6

    Ann Arbor, Michigan 48103
    United States

    Site Not Available

  • Investigational Site 12

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Investigational Site 26

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Investigational Site 17

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Investigational Site 25

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Investigational Site 29

    Forest Hills, New York 11375
    United States

    Site Not Available

  • Investigational Site 28

    Rochester, New York 14623
    United States

    Site Not Available

  • Investigational Site 4

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Investigational Site 18

    Fountain Inn, South Carolina 29644
    United States

    Site Not Available

  • Investigational Site 27

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Investigational Site 9

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Investigational Site 8

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • Investigational Site 5

    Austin, Texas 78759
    United States

    Site Not Available

  • Investigational Site 11

    College Station, Texas 77845
    United States

    Site Not Available

  • Investigational Site 16

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Investigational Site 19

    San Antonio, Texas 78249
    United States

    Site Not Available

  • Investigational Site 31

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Investigational Site 23

    Richmond, Virginia 23294
    United States

    Site Not Available

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