To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp Psoriasis
NCT ID: NCT03331523
Last Updated: 2018-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
643 participants
INTERVENTIONAL
2017-10-20
2018-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Calcipotriene/betamethasone dipropionate
Calcipotriene/Betamethasone Dipropionate
Topical suspension 0.005%/0.064% (Glenmark Pharmaceuticals Ltd)
Taclonex®
Taclonex®
Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (LEO Pharma Inc.)
Placebo
Placebo
Placebo of Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd.)
Interventions
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Calcipotriene/Betamethasone Dipropionate
Topical suspension 0.005%/0.064% (Glenmark Pharmaceuticals Ltd)
Taclonex®
Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (LEO Pharma Inc.)
Placebo
Placebo of Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd.)
Eligibility Criteria
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Inclusion Criteria
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 moderate disease severity (Grade ≥ 3).
4. A plaque elevation of at least moderate severity (Grade ≥ 3) at the scalp target lesion site. The most severe scalp lesion at baseline should be identified as the target lesion.
Exclusion Criteria
2. Other inflammatory skin disease in the scalp that may confound the evaluation of the scalp psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea capitis).
3. Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the scalp 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 UVB during the study.
18 Years
ALL
No
Sponsors
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Glenmark Pharmaceuticals Ltd. India
INDUSTRY
Responsible Party
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Principal Investigators
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William Todd Kays
Role: STUDY_DIRECTOR
Glenmark Pharmaceuticals Inc., USA
Locations
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Investigational Site 24
Encinitas, California, United States
Investigational Site 3
Fremont, California, United States
Investigational Site 13
San Diego, California, United States
Investigational Site 20
San Diego, California, United States
Investigational Site 32
Santa Monica, California, United States
Investigational Site 14
Denver, Colorado, United States
Investigational Site 1
Miami, Florida, United States
Investigational Site 30
Miami, Florida, United States
Investigational Site 7
Miramar, Florida, United States
Investigational Site 22
Tampa, Florida, United States
Investigational Site 15
New Albany, Indiana, United States
Investigational Site 10
South Bend, Indiana, United States
Investigational Site 21
Louisville, Kentucky, United States
Investigational Site 6
Ann Arbor, Michigan, United States
Investigational Site 12
Fridley, Minnesota, United States
Investigational Site 26
Saint Joseph, Missouri, United States
Investigational Site 17
Henderson, Nevada, United States
Investigational Site 25
Las Vegas, Nevada, United States
Investigational Site 29
Forest Hills, New York, United States
Investigational Site 28
Rochester, New York, United States
Investigational Site 4
High Point, North Carolina, United States
Investigational Site 18
Fountain Inn, South Carolina, United States
Investigational Site 27
Mt. Pleasant, South Carolina, United States
Investigational Site 9
Knoxville, Tennessee, United States
Investigational Site 8
Nashville, Tennessee, United States
Investigational Site 5
Austin, Texas, United States
Investigational Site 11
College Station, Texas, United States
Investigational Site 16
San Antonio, Texas, United States
Investigational Site 19
San Antonio, Texas, United States
Investigational Site 31
Norfolk, Virginia, United States
Investigational Site 23
Richmond, Virginia, United States
Countries
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Other Identifiers
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GLK-1701
Identifier Type: -
Identifier Source: org_study_id