ClinicalTrials.gg
CompletedNCT03731091Updated Aug 19, 2020

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

A Phase 3 interventional study of Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064% and Enstilar® foam (LEO Pharma Inc.) in Psoriasis Vulgaris, sponsored by Glenmark Pharmaceuticals Ltd. India. Completed at 30 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-19.

Sponsored by Glenmark Pharmaceuticals Ltd. India · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2020, 6 years 7 months ago, and no results have been posted to the registry.
Phase
Phase 3
Study type
Interventional
Enrollment
494
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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)

02

Conditions studied

  • Psoriasis Vulgaris

Browse trials for

03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's enrollment of 494 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Glenmark Pharmaceuticals Ltd. India is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 . -

Exclusion criteria

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 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 .
  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 , 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.

    -

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
494 participants (actual)

Study arms

  • 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%

  • Active comparator
    Enstilar®

    Topical foam once daily for 4 weeks (28 days)

    Drug: Enstilar® foam (LEO Pharma Inc.)

  • Placebo comparator
    Placebo

    Topical foam once daily for 4 weeks (28 days)

    Other: Placebo of Calcipotriene/ betamethasone dipropionate topical foam

Interventions

  • DrugCalcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064%

    Once daily for 4 weeks (28 days)

  • DrugEnstilar® foam (LEO Pharma Inc.)

    Once daily for 4 weeks (28 days)

  • OtherPlacebo of Calcipotriene/ betamethasone dipropionate topical foam

    Once daily for 4 weeks (28 days)

06

What researchers measure

Primary outcomes

  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

    Time frame: 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

    Time frame: Day 29

07

Study locations

30 sites
  • Investigational Site 20
    Encinitas, California 92024, United States
  • Investigational Site 18
    Fountain Valley, California 92708, United States
  • Investigational Site 19
    San Diego, California 92108, United States
  • Investigational Site 15
    San Diego, California 92123, United States
  • Investigational Site 23
    San Diego, California 92123, United States
  • Investigational Site 17
    Santa Ana, California 92705, United States
  • Investigational Site 22
    Santa Monica, California 90404, United States
  • Investigational Site 29
    Clearwater, Florida 33761, United States
  • Investigational Site 27
    Coral Gables, Florida 33134, United States
  • Investigational Site 1
    Miami, Florida 33144, United States
  • Investigational Site 26
    Pinellas Park, Florida 33781, United States
  • Investigational Site 10
    New Albany, Indiana 47150, United States
  • Investigational Site 3
    Overland Park, Kansas 66215, United States
  • Investigational Site 16
    Louisville, Kentucky 40241, United States
  • Investigational Site 21
    Saint Joseph, Missouri 64506, United States
  • Investigational Site 12
    Henderson, Nevada 89052, United States
  • Investigational Site 28
    New York, New York 10019, United States
  • Investigational Site 4
    High Point, North Carolina 27262, United States
  • Investigational Site 24
    Wilmington, North Carolina 28405, United States
  • Investigational Site 8
    Beachwood, Ohio 44122, United States
  • Investigational Site 2
    Cincinnati, Ohio 45246, United States
  • Investigational Site 13
    Greenville, South Carolina 29607, United States
  • Investigational Site 7
    Knoxville, Tennessee 37922, United States
  • Investigational site 31
    Murfreesboro, Tennessee 37130, United States
  • Investigational Site 25
    Nashville, Tennessee 37215, United States
  • Investigational Site 5
    Austin, Texas 78759, United States
  • Investigational Site 11
    San Antonio, Texas 78213, United States
  • Investigational Site 14
    San Antonio, Texas 78249, United States
  • Investigational Site 30
    Webster, Texas 77598, United States
  • Investigational Site 6
    Norfolk, Virginia 23507, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2018 to primary completion in Mar 2020, 16 months.

Of 217 industry-sponsored phase 3 interventional studies under Psoriasis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 16 months is close to that.

Counting every sponsor, half of 227 studies reached it within 15 months; a quarter within 10 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 31, 2018
First posted
Nov 6, 2018
StartActual
Oct 31, 2018
Primary completionActual
Mar 17, 2020
CompletionActual
Mar 17, 2020
Last update
Aug 19, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03731091
Lead sponsor
Glenmark Pharmaceuticals Ltd. India
Responsible party
Sponsor
First posted
Nov 6, 2018
Start date
Oct 31, 2018
Primary completion
Mar 17, 2020
Completion
Mar 17, 2020
Last update
Aug 19, 2020

Study contacts

William Todd Kays
study director · Glenmark Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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