BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension in the Treatment of Scalp Psoriasis

Completed · Phase 1 · Has a placebo group

Conditions studied: Scalp Psoriasis

In brief

This study will be conducted to evaluate the therapeutic bioequivalence of a TEST formulation of calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% to the RLD.

Key facts

Study ID

NCT03122353

Run by

Tolmar Inc.

People needed

699

Starts

2017-04-11

Expected to finish

2017-11-15

Last updated by the study team

2018-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or non-pregnant, non-lactating female, at least 18 years of age.
• Female subjects of childbearing potential (excluding women who are or premenarchal, surgically sterilized or postmenopausal for at least 2 years).
• 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.
• Scalp psoriasis consistent with at least moderate disease severity (grade ≥ 3) using the Physician's Global Assessment (PGA) of disease severity.
• Plaque elevation of at least moderate severity (grade ≥ 3) at the scalp target lesion site using the Psoriasis Area Severity Index (PASI). The most severe lesion at Baseline will be identified as the scalp target lesion.
• Agree to stop use of all other topical or systemic antipsoriatic treatments, corticosteroids, immunosuppressive drugs, calcium supplements and Vitamin D supplements or Vitamin D analogs at a dose > 400 IU/day during the study.
• Currently in general good health and free from any clinically significant disease, other than scalp psoriasis and psoriasis vulgaris, that may interfere with the study evaluations.
• Willing and able to understand and comply with the requirements of the study, apply IP as instructed, attend required study visits, comply with study prohibitions, and be able to complete the study.

You may not qualify if…

• Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
• Other inflammatory skin disease in the scalp that may confound the evaluation of the scalp psoriasis (eg, atopic dermatitis, contact dermatitis, tinea capitis).
• History of hypersensitivity to any component of TEST or RLD.
• Current or past history of hypercalcemia, hypercalciuria, vitamin D toxicity, severe renal insufficiency, or hepatic disorders.

Where it is running

• Site 17 — Hot Springs, Arkansas, United States
• Site 29 — Fremont, California, United States
• Site 12 — Los Angeles, California, United States
• Site 18 — Sherman Oaks, California, United States
• Site 34 — Denver, Colorado, United States
• Site 20 — Boca Raton, Florida, United States
• Site 01 — Brandon, Florida, United States
• Site 25 — Coral Gables, Florida, United States
• Site 11 — Hialeah, Florida, United States
• Site 26 — Miami, Florida, United States
• Site 04 — Miami, Florida, United States
• Site 05 — Miramar, Florida, United States
• Site 02 — Tampa, Florida, United States
• Site 03 — Tampa, Florida, United States
• Site 23 — Winter Park, Florida, United States
• Site 16 — Plainfield, Indiana, United States
• Site 19 — Olathe, Kansas, United States
• Site 33 — Lake Charles, Louisiana, United States
• Site 27 — Saint Joseph, Missouri, United States
• Site 14 — Las Vegas, Nevada, United States
• Site 09 — High Point, North Carolina, United States
• Site 28 — Hazleton, Pennsylvania, United States
• Site 24 — Upper Saint Clair, Pennsylvania, United States
• Site 32 — Johnston, Rhode Island, United States
• Site 07 — Anderson, South Carolina, United States

Full record on ClinicalTrials.gov

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