To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064%, in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis).

Psoriasis Vulgaris Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03731091
• Other study ID #: GLK-1801
• Status: Completed
• Phase: Phase 3
• Start date: October 31, 2018
• Est. completion date: March 17, 2020

Study information

• Verified date: August 2020
• Source: Glenmark Pharmaceuticals Ltd. India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: March 17, 2020
• Est. primary completion date: March 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064%
Once daily for 4 weeks (28 days)
• Enstilar® foam (LEO Pharma Inc.)
Once daily for 4 weeks (28 days)

Other:
• Placebo of Calcipotriene/ betamethasone dipropionate topical foam
Once daily for 4 weeks (28 days)

Locations

Country	Name	City	State
United States	Investigational Site 5	Austin	Texas
United States	Investigational Site 8	Beachwood	Ohio
United States	Investigational Site 2	Cincinnati	Ohio
United States	Investigational Site 29	Clearwater	Florida
United States	Investigational Site 27	Coral Gables	Florida
United States	Investigational Site 20	Encinitas	California
United States	Investigational Site 18	Fountain Valley	California
United States	Investigational Site 13	Greenville	South Carolina
United States	Investigational Site 12	Henderson	Nevada
United States	Investigational Site 4	High Point	North Carolina
United States	Investigational Site 7	Knoxville	Tennessee
United States	Investigational Site 16	Louisville	Kentucky
United States	Investigational Site 1	Miami	Florida
United States	Investigational site 31	Murfreesboro	Tennessee
United States	Investigational Site 25	Nashville	Tennessee
United States	Investigational Site 10	New Albany	Indiana
United States	Investigational Site 28	New York	New York
United States	Investigational Site 6	Norfolk	Virginia
United States	Investigational Site 3	Overland Park	Kansas
United States	Investigational Site 26	Pinellas Park	Florida
United States	Investigational Site 21	Saint Joseph	Missouri
United States	Investigational Site 11	San Antonio	Texas
United States	Investigational Site 14	San Antonio	Texas
United States	Investigational Site 15	San Diego	California
United States	Investigational Site 19	San Diego	California
United States	Investigational Site 23	San Diego	California
United States	Investigational Site 17	Santa Ana	California
United States	Investigational Site 22	Santa Monica	California
United States	Investigational Site 30	Webster	Texas
United States	Investigational Site 24	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Glenmark Pharmaceuticals Ltd. India

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects in each treatment group with treatment success	Treatment success defined as none or minimal disease , a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity	Day 29
Primary	The proportion of subjects in each treatment group with clinical success	Clinical success defined as clear or almost clear, a score of 0 or 1, at the target lesion site on the PASI scale. Each psoriatic sign of scaling, erythema, and plaque elevation should have a score of 0 or 1	Day 29