Clinical trial NCT03122353: BE Study of Calcipotriene Hydrate and Betamethasone Dipropionate Topical Suspension in the Treatment of Scalp Psoriasis
Official title: A Randomized, Double-Blind Study Comparing TOLMAR Calcipotriene and Betamethasone Suspension to Reference Listed Drug in the Treatment of Scalp Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Scalp Psoriasis
Lead sponsor: Tolmar Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-20
Enrollment: 699
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Psoriasis Area Severity Index (PASI)
timeFrame: at Day 1, Day 28
measure: Physician Global Assessment (PGA)
timeFrame: at Day 1, Day 28
measure: Body Surface Area (BSA)
timeFrame: at Day 1
measure: Adverse Events and Serious Adverse Events
timeFrame: at Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Site 17
state: Arkansas
city: Fremont
country: United States
facility: Site 29
state: California
city: Los Angeles
country: United States
facility: Site 12
state: California
city: Sherman Oaks
country: United States
facility: Site 18
state: California
city: Denver
country: United States
facility: Site 34
state: Colorado
city: Boca Raton
country: United States
facility: Site 20
state: Florida
city: Brandon
country: United States
facility: Site 01
state: Florida
city: Coral Gables
country: United States
facility: Site 25
state: Florida
city: Hialeah
country: United States
facility: Site 11
state: Florida
city: Miami
country: United States
facility: Site 26
state: Florida
city: Miami
country: United States
facility: Site 04
state: Florida
city: Miramar
country: United States
facility: Site 05
state: Florida
city: Tampa
country: United States
facility: Site 02
state: Florida
city: Tampa
country: United States
facility: Site 03
state: Florida
city: Winter Park
country: United States
facility: Site 23
state: Florida
city: Plainfield
country: United States
facility: Site 16
state: Indiana
city: Olathe
country: United States
facility: Site 19
state: Kansas
city: Lake Charles
country: United States
facility: Site 33
state: Louisiana
city: Saint Joseph
country: United States
facility: Site 27
state: Missouri
city: Las Vegas
country: United States
facility: Site 14
state: Nevada
city: High Point
country: United States
facility: Site 09
state: North Carolina
city: Hazleton
country: United States
facility: Site 28
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: Site 24
state: Pennsylvania
city: Johnston
country: United States
facility: Site 32
state: Rhode Island
city: Anderson
country: United States
facility: Site 07
state: South Carolina
city: Mount Pleasant
country: United States
facility: Site 35
state: South Carolina
city: Austin
country: United States
facility: Site 21
state: Texas
city: Dallas
country: United States
facility: Site 06
state: Texas
city: El Paso
country: United States
facility: Site 30
state: Texas
city: Murphy
country: United States
facility: Site 08
state: Texas
city: San Antonio
country: United States
facility: Site 15
state: Texas
city: San Antonio
country: United States
facility: Site 31
state: Texas
city: Salt Lake City
country: United States
facility: Site 10
state: Utah
city: Norfolk
country: United States
facility: Site 22
state: Virginia
Study officials:
affiliation: Catawba Research
name: Jim Joffrion
role: STUDY_DIRECTOR
References: