CompletedNCT03331523Updated Dec 21, 2018

To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064%, in the Treatment of Scalp Psoriasis

A Phase 3 interventional study of Calcipotriene/Betamethasone Dipropionate and Taclonex® in Scalp Psoriasis, sponsored by Glenmark Pharmaceuticals Ltd. India. Completed at 31 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-21.

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

From the registry’s dates

Primary completion was Oct 2018, 8 years ago, and no results have been posted to the registry.

Phase: Phase 3
Study type: Interventional
Enrollment: 643
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This is a phase III, randomized, double-blind, placebo-controlled, parallel- group, multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. in the treatment of scalp psoriasis.

Conditions studied

Scalp Psoriasis

Browse trials for

Psoriasis 2,028

In context

Psoriasis

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

This study's enrollment of 643 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.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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) scalp psoriasis involving at least 10% of the scalp and clinical signs of psoriasis vulgaris on trunk and/or limbs.
A PGA of disease severity of the scalp psoriasis consistent with at least moderate disease severity (Grade ≥ 3).
A plaque elevation of at least moderate severity (Grade ≥ 3) at the scalp target lesion site. The most severe scalp lesion at baseline should be identified as the target lesion.

Exclusion criteria

Exclusion Criteria:

Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis.
Other inflammatory skin disease in the scalp that may confound the evaluation of the scalp psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea capitis).
Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the scalp that could interfere with the rating of efficacy parameters.
Presence of viral lesions, fungal, bacterial, or parasitic infections and/or atrophic (thinning) skin on the scalp.
History of psoriasis unresponsive to topical treatments.
Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB during the study.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 643 participants (actual)

Study arms

Experimental
Calcipotriene/betamethasone dipropionate
Drug: Calcipotriene/Betamethasone Dipropionate
Active comparator
Taclonex®
Drug: Taclonex®
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugCalcipotriene/Betamethasone Dipropionate
Drug pages: Calcipotriene · Betamethasone dipropionate
Topical suspension 0.005%/0.064% (Glenmark Pharmaceuticals Ltd)
DrugTaclonex®
Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (LEO Pharma Inc.)
DrugPlacebo
Placebo of Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd.)

What researchers measure

Primary outcomes

Proportion of subjects in each treatment group with treatment success, defined as a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity, at the end of study visit.
Time frame: Day 29
Proportion of subjects in each treatment group with clinical success, defined as a score of 0 or 1, at the target lesion site on the PASI scale at the end of study visit.
Time frame: Day 29

Study locations

31 sites

Investigational Site 24
Encinitas, California 92024, United States
Investigational Site 3
Fremont, California 94538, United States
Investigational Site 13
San Diego, California 92108, United States
Investigational Site 20
San Diego, California 92123, United States
Investigational Site 32
Santa Monica, California 90404, United States
Investigational Site 14
Denver, Colorado 80220, United States
Investigational Site 1
Miami, Florida 33144, United States
Investigational Site 30
Miami, Florida 33175, United States
Investigational Site 7
Miramar, Florida 33027, United States
Investigational Site 22
Tampa, Florida 33609, United States
Investigational Site 15
New Albany, Indiana 47150, United States
Investigational Site 10
South Bend, Indiana 46617, United States
Investigational Site 21
Louisville, Kentucky 40241, United States
Investigational Site 6
Ann Arbor, Michigan 48103, United States
Investigational Site 12
Fridley, Minnesota 55432, United States
Investigational Site 26
Saint Joseph, Missouri 64506, United States
Investigational Site 17
Henderson, Nevada 89052, United States
Investigational Site 25
Las Vegas, Nevada 89128, United States
Investigational Site 29
Forest Hills, New York 11375, United States
Investigational Site 28
Rochester, New York 14623, United States
Investigational Site 4
High Point, North Carolina 27262, United States
Investigational Site 18
Fountain Inn, South Carolina 29644, United States
Investigational Site 27
Mount Pleasant, South Carolina 29464, United States
Investigational Site 9
Knoxville, Tennessee 37922, United States
Investigational Site 8
Nashville, Tennessee 37215, United States
Investigational Site 5
Austin, Texas 78759, United States
Investigational Site 11
College Station, Texas 77845, United States
Investigational Site 16
San Antonio, Texas 78213, United States
Investigational Site 19
San Antonio, Texas 78249, United States
Investigational Site 31
Norfolk, Virginia 23507, United States
Investigational Site 23
Richmond, Virginia 23294, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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 2017 to primary completion in Oct 2018, 12 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 12 months is below 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: Nov 1, 2017
First posted: Nov 6, 2017
StartActual: Oct 20, 2017
Primary completionActual: Oct 25, 2018
CompletionActual: Oct 25, 2018
Last update: Dec 21, 2018

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 Dec 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03331523
Lead sponsor: Glenmark Pharmaceuticals Ltd. India
Responsible party: Sponsor
First posted: Nov 6, 2017
Start date: Oct 20, 2017
Primary completion: Oct 25, 2018
Completion: Oct 25, 2018
Last update: Dec 21, 2018

Study contacts

William Todd Kays

study director · Glenmark Pharmaceuticals Inc., USA

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 Dec 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Calcipotriene · Betamethasone dipropionate

Other studies in this condition

Psoriasis →

Other studies from this sponsor

Glenmark Pharmaceuticals Ltd. India

Start the discussion