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Psoriasis VulgarisPhase 3NCT03731091

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

A Phase 3 study testing Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064% and Enstilar® foam (LEO Pharma Inc.) in people with Psoriasis Vulgaris, run by Glenmark Pharmaceuticals Ltd. India at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Psoriasis Vulgaris
What is being tested?
Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064% and Enstilar® foam (LEO Pharma Inc.)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
494 participants
Where
30 sitesUnited States
Study dates
31 Oct 2018to 17 Mar 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or non-pregnant, non-lactating female subjects aged at least 18 years at Visit 1.
  • 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.
  • A PGA of disease severity of at least moderate disease severity (Grade ≥ 3).
  • 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.
  • Provide written informed consent. -

Who cannot join

  • Current diagnosis of unstable forms of psoriasis in the treatment area including guttate, erythrodermic, exfoliative, or pustular psoriasis.
  • 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).
  • Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas that could interfere with the rating of efficacy parameters.
  • History of psoriasis unresponsive to topical treatments.
  • History of hypersensitivity to any component of the Test or Reference product.
  • Current or past history of hypercalcemia, calcium metabolism disorder, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders.
Show all 16Show fewer
  • Current immunosuppression.
  • Use within 6 months prior to baseline of biologic treatment for psoriasis (e.g., infliximab, adalimumab, alefacept).
  • Use within 3 months prior to baseline of: 1) chemotherapy or 2) radiation therapy.
  • Use within 2 months prior to baseline of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus) or 2) oral retinoids.
  • 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.
  • 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.
  • 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).
  • 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.
  • Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB during the study.
  • -

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • Investigational Site 5

    Austin, Texas, 78759

  • Investigational Site 8

    Beachwood, Ohio, 44122

  • Investigational Site 2

    Cincinnati, Ohio, 45246

  • Investigational Site 29

    Clearwater, Florida, 33761

  • Investigational Site 27

    Coral Gables, Florida, 33134

  • Investigational Site 20

    Encinitas, California, 92024

  • Investigational Site 18

    Fountain Valley, California, 92708

  • Investigational Site 13

    Greenville, South Carolina, 29607

  • Investigational Site 12

    Henderson, Nevada, 89052

  • Investigational Site 4

    High Point, North Carolina, 27262

  • Investigational Site 7

    Knoxville, Tennessee, 37922

  • Investigational Site 16

    Louisville, Kentucky, 40241

  • Investigational Site 1

    Miami, Florida, 33144

  • Investigational site 31

    Murfreesboro, Tennessee, 37130

  • Investigational Site 25

    Nashville, Tennessee, 37215

  • Investigational Site 10

    New Albany, Indiana, 47150

  • Investigational Site 28

    New York, New York, 10019

  • Investigational Site 6

    Norfolk, Virginia, 23507

  • Investigational Site 3

    Overland Park, Kansas, 66215

  • Investigational Site 26

    Pinellas Park, Florida, 33781

  • Investigational Site 21

    Saint Joseph, Missouri, 64506

  • Investigational Site 11

    San Antonio, Texas, 78213

  • Investigational Site 14

    San Antonio, Texas, 78249

  • Investigational Site 19

    San Diego, California, 92108

  • Investigational Site 15

    San Diego, California, 92123

  • Investigational Site 23

    San Diego, California, 92123

  • Investigational Site 17

    Santa Ana, California, 92705

  • Investigational Site 22

    Santa Monica, California, 90404

  • Investigational Site 30

    Webster, Texas, 77598

  • Investigational Site 24

    Wilmington, North Carolina, 28405

Other trials in United States

About this study

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)

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)

Being tested
Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064%, Enstilar® foam (LEO Pharma Inc.), Placebo of Calcipotriene/ betamethasone dipropionate topical foam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064%Drug

    Once daily for 4 weeks (28 days)

  • Enstilar® foam (LEO Pharma Inc.)Drug

    Once daily for 4 weeks (28 days)

  • Placebo of Calcipotriene/ betamethasone dipropionate topical foamOther

    Once daily for 4 weeks (28 days)

Study groups in NCT03731091
Study groupRoleWhat they receive
Calcipotriene/ betamethasone dipropionate topical foamExperimentalTopical foam once daily for 4 weeks (28 days)
Receives: Drug: Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064%
Enstilar®Active comparatorTopical foam once daily for 4 weeks (28 days)
Receives: Drug: Enstilar® foam (LEO Pharma Inc.)
PlaceboPlacebo comparatorTopical foam once daily for 4 weeks (28 days)
Receives: Other: Placebo of Calcipotriene/ betamethasone dipropionate topical foam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 29

  2. 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

    Measured: Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2018
  2. Study start31 Oct 2018
  3. Primary completion17 Mar 2020
  4. Study completion17 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
494 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03731091
Sponsor's protocol ID
GLK-1801
Status last verified
Aug 2020
First submitted
31 Oct 2018
Last updated
19 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064% and Enstilar® foam (LEO Pharma Inc.) in people with Psoriasis Vulgaris, run by Glenmark Pharmaceuticals Ltd. India at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of subjects in each treatment group with treatment success (time frame: Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03731091.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.

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