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

Launched by GLENMARK PHARMACEUTICALS LTD. INDIA · Nov 2, 2018

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Gender

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Eligibility criteria

• 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 lesion site. The most severe lesion at baseline should be identified as the target lesion.
• • 5. Provide written informed consent. -
• Exclusion Criteria:
• • 1. Current diagnosis of unstable forms of psoriasis in the treatment area including guttate, erythrodermic, exfoliative, or pustular psoriasis.
• • 2. 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).
• • 3. Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment 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 D toxicity, 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) 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.
• • 12. 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.
• • 13. 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).
• • 14. 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.
• • 15. Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB during the study.
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