Clinical trial NCT03731091: To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064%, in the Treatment of Psoriasis Vulgaris (Plaque 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 Foam, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Enstilar® Foam (LEO Pharma Inc.) in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis Vulgaris
Lead sponsor: Glenmark Pharmaceuticals Ltd. India
Sponsor class: INDUSTRY
First posted: 2018-11-06
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 Foam, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Enstilar® Foam (LEO Pharma Inc.) in the Treatment of Psoriasis Vulgaris (Plaque 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) 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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Primary outcomes:
measure: The proportion of subjects in each treatment group with treatment success
timeFrame: Day 29
measure: The proportion of subjects in each treatment group with clinical success
timeFrame: Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Investigational Site 20
state: California
city: Fountain Valley
country: United States
facility: Investigational Site 18
state: California
city: San Diego
country: United States
facility: Investigational Site 19
state: California
city: San Diego
country: United States
facility: Investigational Site 15
state: California
city: San Diego
country: United States
facility: Investigational Site 23
state: California
city: Santa Ana
country: United States
facility: Investigational Site 17
state: California
city: Santa Monica
country: United States
facility: Investigational Site 22
state: California
city: Clearwater
country: United States
facility: Investigational Site 29
state: Florida
city: Coral Gables
country: United States
facility: Investigational Site 27
state: Florida
city: Miami
country: United States
facility: Investigational Site 1
state: Florida
city: Pinellas Park
country: United States
facility: Investigational Site 26
state: Florida
city: New Albany
country: United States
facility: Investigational Site 10
state: Indiana
city: Overland Park
country: United States
facility: Investigational Site 3
state: Kansas
city: Louisville
country: United States
facility: Investigational Site 16
state: Kentucky
city: Saint Joseph
country: United States
facility: Investigational Site 21
state: Missouri
city: Henderson
country: United States
facility: Investigational Site 12
state: Nevada
city: New York
country: United States
facility: Investigational Site 28
state: New York
city: High Point
country: United States
facility: Investigational Site 4
state: North Carolina
city: Wilmington
country: United States
facility: Investigational Site 24
state: North Carolina
city: Beachwood
country: United States
facility: Investigational Site 8
state: Ohio
city: Cincinnati
country: United States
facility: Investigational Site 2
state: Ohio
city: Greenville
country: United States
facility: Investigational Site 13
state: South Carolina
city: Knoxville
country: United States
facility: Investigational Site 7
state: Tennessee
city: Murfreesboro
country: United States
facility: Investigational site 31
state: Tennessee
city: Nashville
country: United States
facility: Investigational Site 25
state: Tennessee
city: Austin
country: United States
facility: Investigational Site 5
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 11
state: Texas
city: San Antonio
country: United States
facility: Investigational Site 14
state: Texas
city: Webster
country: United States
facility: Investigational Site 30
state: Texas
city: Norfolk
country: United States
facility: Investigational Site 6
state: Virginia
Study officials:
affiliation: Glenmark Pharmaceuticals
name: William Todd Kays
role: STUDY_DIRECTOR
References: