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

Completed · Phase 3 · Has a placebo group

Conditions studied: Psoriasis Vulgaris

In brief

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)

Key facts

Study ID

NCT03731091

Run by

Glenmark Pharmaceuticals Ltd. India

People needed

494

Starts

2018-10-31

Expected to finish

2020-03-17

Last updated by the study team

2020-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or non-pregnant, non-lactating female subjects aged at least 18 years at Visit 1.
• 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.
• A PGA of disease severity of at least moderate disease severity (Grade ≥ 3).
• A plaque elevation of at least moderate severity (Grade ≥ 3) at the target lesion site. The most severe lesion at baseline should be identified as the target lesion.
• Provide written informed consent. -

You may not qualify if…

• Current diagnosis of unstable forms of psoriasis in the treatment area including guttate, erythrodermic, exfoliative, or pustular psoriasis.
• Other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
• Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas that could interfere with the rating of efficacy parameters.
• History of psoriasis unresponsive to topical treatments.
• History of hypersensitivity to any component of the Test or Reference product.
• Current or past history of hypercalcemia, calcium metabolism disorder, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders.
• Current immunosuppression.
• Use within 6 months prior to baseline of biologic treatment for psoriasis (e.g., infliximab, adalimumab, alefacept).
• Use within 3 months prior to baseline of: 1) chemotherapy or 2) radiation therapy.
• Use within 2 months prior to baseline of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus) or 2) oral retinoids.
• Use within 1 month prior to baseline of: 1) systemic steroids, 2) systemic antibiotics, 3) other systemic antipsoriatic treatment, 4) psoralen and ultraviolet A (PUVA) therapy, 5) ultraviolet B (UVB) therapy, or 6) systemic anti-inflammatory agents. Note: a) Non-steroidal anti-inflammatory drugs (NSAIDs) and aspirin use on an as-needed basis and if not used consecutively for > 14 days prior to baseline and/or during the study is acceptable. Low-dose (81 mg) aspirin taken daily is acceptable. b) Intranasal or inhaled corticosteroids are acceptable if kept constant throughout the study. Intra-articular steroid injections are permissible.
• Use within 2 weeks prior to baseline of: 1) topical antipsoriatic drugs (e.g., salicylic acid, anthralin, coal tar, calcipotriene, tazarotene), 2) topical corticosteroids, or 3) topical retinoids.
• Use within 2 weeks prior to baseline of: 1) vitamin D supplements 2) vitamin D analogs at a dose >400 IU/day; or 3) calcium supplements (including multivitamins containing calcium).
• Started beta-blocker therapy, antimalarial products, and/or lithium within 3 months of baseline. Subjects who have been on a steady dose for at least 3 months prior to baseline and will remain on the same dose throughout the study are eligible for study participation.
• Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB during the study.

Where it is running

• Investigational Site 20 — Encinitas, California, United States
• Investigational Site 18 — Fountain Valley, California, United States
• Investigational Site 19 — San Diego, California, United States
• Investigational Site 15 — San Diego, California, United States
• Investigational Site 23 — San Diego, California, United States
• Investigational Site 17 — Santa Ana, California, United States
• Investigational Site 22 — Santa Monica, California, United States
• Investigational Site 29 — Clearwater, Florida, United States
• Investigational Site 27 — Coral Gables, Florida, United States
• Investigational Site 1 — Miami, Florida, United States
• Investigational Site 26 — Pinellas Park, Florida, United States
• Investigational Site 10 — New Albany, Indiana, United States
• Investigational Site 3 — Overland Park, Kansas, United States
• Investigational Site 16 — Louisville, Kentucky, United States
• Investigational Site 21 — Saint Joseph, Missouri, United States
• Investigational Site 12 — Henderson, Nevada, United States
• Investigational Site 28 — New York, New York, United States
• Investigational Site 4 — High Point, North Carolina, United States
• Investigational Site 24 — Wilmington, North Carolina, United States
• Investigational Site 8 — Beachwood, Ohio, United States
• Investigational Site 2 — Cincinnati, Ohio, United States
• Investigational Site 13 — Greenville, South Carolina, United States
• Investigational Site 7 — Knoxville, Tennessee, United States
• Investigational site 31 — Murfreesboro, Tennessee, United States
• Investigational Site 25 — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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