Clinical trial NCT03331523: To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp Psoriasis
Official title: 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 Suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Taclonex® Topical Suspension (LEO Pharma Inc.) in the Treatment of Scalp Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scalp Psoriasis
Lead sponsor: Glenmark Pharmaceuticals Ltd. India
Sponsor class: INDUSTRY
First posted: 2017-11-06
Enrollment: 643
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 is a phase III, randomized, double-blind, placebo-controlled, parallel- group, multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. in the treatment of scalp psoriasis.


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) scalp psoriasis involving at least 10% of the scalp and clinical signs of psoriasis vulgaris on trunk and/or limbs.
3. A PGA of disease severity of the scalp psoriasis consistent with at least moderate disease severity (Grade ≥ 3).
4. A plaque elevation of at least moderate severity (Grade ≥ 3) at the scalp target lesion site. The most severe scalp lesion at baseline should be identified as the target lesion.

Exclusion Criteria:

1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis.
2. Other inflammatory skin disease in the scalp that may confound the evaluation of the scalp psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea capitis).
3. Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the scalp that could interfere with the rating of efficacy parameters.
4. Presence of viral lesions, fungal, bacterial, or parasitic infections and/or atrophic (thinning) skin on the scalp.
5. History of psoriasis unresponsive to topical treatments.
6. Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB during the study.

Primary outcomes:
measure: Proportion of subjects in each treatment group with treatment success, defined as a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity, at the end of study visit.
timeFrame: Day 29
measure: Proportion of subjects in each treatment group with clinical success, defined as a score of 0 or 1, at the target lesion site on the PASI scale at the end of study visit.
timeFrame: Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Investigational Site 24
state: California
city: Fremont
country: United States
facility: Investigational Site 3
state: California
city: San Diego
country: United States
facility: Investigational Site 13
state: California
city: San Diego
country: United States
facility: Investigational Site 20
state: California
city: Santa Monica
country: United States
facility: Investigational Site 32
state: California
city: Denver
country: United States
facility: Investigational Site 14
state: Colorado
city: Miami
country: United States
facility: Investigational Site 1
state: Florida
city: Miami
country: United States
facility: Investigational Site 30
state: Florida
city: Miramar
country: United States
facility: Investigational Site 7
state: Florida
city: Tampa
country: United States
facility: Investigational Site 22
state: Florida
city: New Albany
country: United States
facility: Investigational Site 15
state: Indiana
city: South Bend
country: United States
facility: Investigational Site 10
state: Indiana
city: Louisville
country: United States
facility: Investigational Site 21
state: Kentucky
city: Ann Arbor
country: United States
facility: Investigational Site 6
state: Michigan
city: Fridley
country: United States
facility: Investigational Site 12
state: Minnesota
city: Saint Joseph
country: United States
facility: Investigational Site 26
state: Missouri
city: Henderson
country: United States
facility: Investigational Site 17
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site 25
state: Nevada
city: Forest Hills
country: United States
facility: Investigational Site 29
state: New York
city: Rochester
country: United States
facility: Investigational Site 28
state: New York
city: High Point
country: United States
facility: Investigational Site 4
state: North Carolina
city: Fountain Inn
country: United States
facility: Investigational Site 18
state: South Carolina
city: Mount Pleasant
country: United States
facility: Investigational Site 27
state: South Carolina
city: Knoxville
country: United States
facility: Investigational Site 9
state: Tennessee
city: Nashville
country: United States
facility: Investigational Site 8
state: Tennessee
city: Austin
country: United States
facility: Investigational Site 5
state: Texas
city: College Station
country: United States
facility: Investigational Site 11
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 16
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 19
state: Texas
city: Norfolk
country: United States
facility: Investigational Site 31
state: Virginia
city: Richmond
country: United States
facility: Investigational Site 23
state: Virginia
Study officials:
affiliation: Glenmark Pharmaceuticals Inc., USA
name: William Todd Kays
role: STUDY_DIRECTOR
References: