BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension in the Treatment of Scalp Psoriasis
- Conditions
- Scalp Psoriasis
- Interventions
- Registration Number
- NCT03122353
- Lead Sponsor
- Tolmar Inc.
- Brief Summary
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.
- Detailed Description
Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 699
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Topical suspension without active ingredient Calcipotriene Hydrate and Betamethasone Calcipotriene and betamethasone suspension Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064% Taclonex Taclonex Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
- Primary Outcome Measures
Name Time Method Adverse Events and Serious Adverse Events at Day 28 Risk for adverse events and serious adverse events for exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis
Physician Global Assessment (PGA) at Day 1, Day 28 To evaluate the change in global severity of skin of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex, and Vehicle for scalp psoriasis. From baseline to end of study.
Psoriasis Area Severity Index (PASI) at Day 1, Day 28 To evaluate the change in clinical outcome of patients exposed to Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%, Taclonex and Vehicle for scalp psoriasis. From baseline to end of study.
Body Surface Area (BSA) at Day 1 To evaluate the total body area of skin affected by psoriasis.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
Site 29
🇺🇸Fremont, California, United States
Site 18
🇺🇸Sherman Oaks, California, United States
Site 01
🇺🇸Brandon, Florida, United States
Site 25
🇺🇸Coral Gables, Florida, United States
Site 16
🇺🇸Plainfield, Indiana, United States
Site 05
🇺🇸Miramar, Florida, United States
Site 33
🇺🇸Lake Charles, Louisiana, United States
Site 24
🇺🇸Upper Saint Clair, Pennsylvania, United States
Site 09
🇺🇸High Point, North Carolina, United States
Site 32
🇺🇸Johnston, Rhode Island, United States
Site 30
🇺🇸El Paso, Texas, United States
Site 08
🇺🇸Murphy, Texas, United States
Site 22
🇺🇸Norfolk, Virginia, United States
Site 19
🇺🇸Olathe, Kansas, United States
Site 04
🇺🇸Miami, Florida, United States
Site 03
🇺🇸Tampa, Florida, United States
Site 17
🇺🇸Hot Springs, Arkansas, United States
Site 06
🇺🇸Dallas, Texas, United States
Site 21
🇺🇸Austin, Texas, United States
Site 12
🇺🇸Los Angeles, California, United States
Site 34
🇺🇸Denver, Colorado, United States
Site 20
🇺🇸Boca Raton, Florida, United States
Site 11
🇺🇸Hialeah, Florida, United States
Site 26
🇺🇸Miami, Florida, United States
Site 02
🇺🇸Tampa, Florida, United States
Site 23
🇺🇸Winter Park, Florida, United States
Site 27
🇺🇸Saint Joseph, Missouri, United States
Site 14
🇺🇸Las Vegas, Nevada, United States
Site 07
🇺🇸Anderson, South Carolina, United States
Site 15
🇺🇸San Antonio, Texas, United States
Site 31
🇺🇸San Antonio, Texas, United States
Site 10
🇺🇸Salt Lake City, Utah, United States
Site 28
🇺🇸Hazleton, Pennsylvania, United States
Site 35
🇺🇸Mount Pleasant, South Carolina, United States