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

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ClinicalTrials.gov Identifier: NCT03731091
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Glenmark Pharmaceuticals Ltd. India

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)

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064% Drug: Enstilar® foam (LEO Pharma Inc.) Other: Placebo of Calcipotriene/ betamethasone dipropionate topical foam Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 585 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Treatment
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)
Actual Study Start Date : October 31, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019


Arm Intervention/treatment
Experimental: Calcipotriene/ betamethasone dipropionate topical foam
Topical foam once daily for 4 weeks (28 days)
Drug: Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064%
Once daily for 4 weeks (28 days)

Active Comparator: Enstilar®
Topical foam once daily for 4 weeks (28 days)
Drug: Enstilar® foam (LEO Pharma Inc.)
Once daily for 4 weeks (28 days)

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




Primary Outcome Measures :
  1. The proportion of subjects in each treatment group with treatment success [ Time Frame: Day 29 ]
    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

  2. The proportion of subjects in each treatment group with clinical success [ Time Frame: Day 29 ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731091


Contacts
Contact: Nikhil Sawant 91 22 6138 3131 ext 205 nikhil.sawant@glenmarkpharma.com
Contact: Mahesh Deshpande 91 22 6138 3131 ext 208 mahesh.deshpande@glenmarkpharma.com

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Sponsors and Collaborators
Glenmark Pharmaceuticals Ltd. India
Investigators
Study Director: William Todd Kays Glenmark Pharmaceuticals

Responsible Party: Glenmark Pharmaceuticals Ltd. India
ClinicalTrials.gov Identifier: NCT03731091     History of Changes
Other Study ID Numbers: GLK-1801
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Calcipotriene
Calcitriol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents