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
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)
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 →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.
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.
Exclusion Criteria:
Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB during the study.
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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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topical foam once daily for 4 weeks (28 days)
Drug: Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064%
Topical foam once daily for 4 weeks (28 days)
Drug: Enstilar® foam (LEO Pharma Inc.)
Topical foam once daily for 4 weeks (28 days)
Other: Placebo of Calcipotriene/ betamethasone dipropionate topical foam
Once daily for 4 weeks (28 days)
Once daily for 4 weeks (28 days)
Once daily for 4 weeks (28 days)
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
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
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.
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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Glenmark Pharmaceuticals Ltd. India