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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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. -

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03731091
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Glenmark Pharmaceuticals Ltd. India
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

William Todd Kays
Principal Investigator Affiliation Glenmark Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis Vulgaris
Arms & Interventions

Arms

Experimental: Calcipotriene/ betamethasone dipropionate topical foam

Topical foam once daily for 4 weeks (28 days)

Active Comparator: Enstilar®

Topical foam once daily for 4 weeks (28 days)

Placebo Comparator: Placebo

Topical foam once daily for 4 weeks (28 days)

Interventions

Drug: - Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064%

Once daily for 4 weeks (28 days)

Drug: - 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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Investigational Site 20, Encinitas, California

Status

Recruiting

Address

Investigational Site 20

Encinitas, California, 92024

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 18, Fountain Valley, California

Status

Not yet recruiting

Address

Investigational Site 18

Fountain Valley, California, 92708

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 19, San Diego, California

Status

Recruiting

Address

Investigational Site 19

San Diego, California, 92108

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 15, San Diego, California

Status

Recruiting

Address

Investigational Site 15

San Diego, California, 92123

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 23, San Diego, California

Status

Recruiting

Address

Investigational Site 23

San Diego, California, 92123

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 17, Santa Ana, California

Status

Recruiting

Address

Investigational Site 17

Santa Ana, California, 92705

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 22, Santa Monica, California

Status

Recruiting

Address

Investigational Site 22

Santa Monica, California, 90404

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 29, Clearwater, Florida

Status

Recruiting

Address

Investigational Site 29

Clearwater, Florida, 33761

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 27, Coral Gables, Florida

Status

Recruiting

Address

Investigational Site 27

Coral Gables, Florida, 33134

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 1, Miami, Florida

Status

Recruiting

Address

Investigational Site 1

Miami, Florida, 33144

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 26, Pinellas Park, Florida

Status

Recruiting

Address

Investigational Site 26

Pinellas Park, Florida, 33781

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 9, Savannah, Georgia

Status

Withdrawn

Address

Investigational Site 9

Savannah, Georgia, 31406

Investigational Site 10, New Albany, Indiana

Status

Recruiting

Address

Investigational Site 10

New Albany, Indiana, 47150

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 3, Overland Park, Kansas

Status

Recruiting

Address

Investigational Site 3

Overland Park, Kansas, 66215

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 16, Louisville, Kentucky

Status

Recruiting

Address

Investigational Site 16

Louisville, Kentucky, 40241

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 21, Saint Joseph, Missouri

Status

Recruiting

Address

Investigational Site 21

Saint Joseph, Missouri, 64506

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 12, Henderson, Nevada

Status

Recruiting

Address

Investigational Site 12

Henderson, Nevada, 89052

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 28, New York, New York

Status

Recruiting

Address

Investigational Site 28

New York, New York, 10019

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 4, High Point, North Carolina

Status

Recruiting

Address

Investigational Site 4

High Point, North Carolina, 27262

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 24, Wilmington, North Carolina

Status

Recruiting

Address

Investigational Site 24

Wilmington, North Carolina, 28405

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 8, Beachwood, Ohio

Status

Recruiting

Address

Investigational Site 8

Beachwood, Ohio, 44122

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 2, Cincinnati, Ohio

Status

Recruiting

Address

Investigational Site 2

Cincinnati, Ohio, 45246

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 13, Greenville, South Carolina

Status

Recruiting

Address

Investigational Site 13

Greenville, South Carolina, 29607

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 7, Knoxville, Tennessee

Status

Recruiting

Address

Investigational Site 7

Knoxville, Tennessee, 37922

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational site 31, Murfreesboro, Tennessee

Status

Not yet recruiting

Address

Investigational site 31

Murfreesboro, Tennessee, 37130

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 25, Nashville, Tennessee

Status

Recruiting

Address

Investigational Site 25

Nashville, Tennessee, 37215

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 5, Austin, Texas

Status

Recruiting

Address

Investigational Site 5

Austin, Texas, 78759

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 11, San Antonio, Texas

Status

Recruiting

Address

Investigational Site 11

San Antonio, Texas, 78213

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 14, San Antonio, Texas

Status

Recruiting

Address

Investigational Site 14

San Antonio, Texas, 78249

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 30, Webster, Texas

Status

Recruiting

Address

Investigational Site 30

Webster, Texas, 77598

Site Contact

Central Contact

[email protected]

91 22 6138 3131

Investigational Site 6, Norfolk, Virginia

Status

Recruiting

Address

Investigational Site 6

Norfolk, Virginia, 23507

Site Contact

Central Contact

ni[email protected]

91 22 6138 3131

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