NCT01536938 is a Phase 2 clinical trial of LEO 90100 in Psoriasis Vulgaris, sponsored by LEO Pharma.

Who is sponsoring NCT01536938?

NCT01536938 is sponsored by LEO Pharma.

What drugs are being tested in NCT01536938?

Interventions in NCT01536938: LEO 90100, Calcipotriol, Betamethasone.

What condition does NCT01536938 study?

NCT01536938 studies Psoriasis Vulgaris.

Is NCT01536938 still recruiting?

NCT01536938 is currently completed. Last updated 21 February 2025.

Are results published for NCT01536938?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-02-21 · How we verify

NCT01536938

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

LEO 90100 in the Treatment of Psoriasis Vulgaris

Completed Phase 2 Results posted Last updated 21 February 2025

What this trial tests

Phase 2 trial testing LEO 90100 in Psoriasis Vulgaris in 303 participants. Completed in 1 November 2012.

Timeline

1 May 2012

Primary endpoint
1 September 2012

1 November 2012

Quick facts

Lead sponsor	LEO Pharma
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	303
Start date	1 May 2012
Primary completion	1 September 2012
Estimated completion	1 November 2012
Sites	33 locations across United States

Drugs / interventions tested

LEO 90100 — full drug profile →
Calcipotriol — full drug profile →
Betamethasone (BETAMETHASONE) — full drug profile →

Conditions studied

Psoriasis Vulgaris — all drugs for Psoriasis Vulgaris →

Sponsor

LEO Pharma — full company profile →

Who can join

18 and older, any sex, with Psoriasis Vulgaris. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4.
Time frame: 4 weeks
Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation.

Sponsor's own description

The purpose of this study is to investigate whether LEO 90100, calcipotriol and betamethasone are effective in the treatment of psoriasis vulgaris.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Topical treatments for chronic plaque psoriasis.
Mason AR, Mason J, Cork M, Dooley G, et al · · 2013 · cited 58× · PMID 23543539 · DOI 10.1002/14651858.cd005028.pub3
Fixed Combination Aerosol Foam Calcipotriene 0.005% (Cal) Plus Betamethasone Dipropionate 0.064% (BD) is More Efficacious than Cal or BD Aerosol Foam Alone for Psoriasis Vulgaris: A Randomized, Double-blind, Multicenter, Three-arm, Phase 2 Study.
Lebwohl M, Tyring S, Bukhalo M, Alonso-Llamazares J, et al · · 2016 · cited 31× · PMID 27313822
Aerosol Foam Formulation of Fixed Combination Calcipotriene Plus Betamethasone Dipropionate is Highly Efficacious in Patients With Psoriasis Vulgaris: Pooled Data From Three Randomized Controlled Studies.
Stein Gold L, Lebwohl M, Menter A, Villumsen J, et al · · 2016 · cited 21× · PMID 27537995
Efficacy of Fixed-combination Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Foam for Scalp Plaque Psoriasis: Additional Analysis of a Phase II, Randomized Clinical Study.
Patel DS, Veverka KA, Hansen JB, Yamauchi PS, et al · · 2020 · cited 6× · PMID 32802249
Treating Scalp Psoriasis with Calcipotriene/Betamethasone Dipropionate Fixed-dose Combination Cutaneous Foam: Review of Phase 2 Data
Petersen B, Lebwohl M. · · 2020 · cited 3× · PMID 32820879 · DOI 10.36849/jdd.2020.5168
Calcipotriene Plus Betamethasone Dipropionate Foam for Mild Psoriasis: Pooled Results from Three Randomized Trials.
Veverka KA, Hansen JB, Yaloumis M, Kircik L, et al · · 2021 · PMID 34397196 · DOI 10.36849/jdd.5743
Abstracts of Poster Presentations: MauiDerm 2016 : January 25–29, 2016 • Grand Wailea • Maui, Hawaii
· 2016

Verify or expand the search:

Other trials of LEO 90100

Trials testing the same drug.

NCT05919082 — A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet® Ointment in Adult Chinese Subjects Wit · Phase 3 · completed

Other recruiting trials for Psoriasis Vulgaris

Currently open trials in the same condition.

NCT07426120 — Efficacy and Safety of a Botanical Total Coumarin (TC) Cream in Treating Patients With Psoriasis Vulgaris (PLANTCOAT-III · Phase 3 · recruiting
NCT07320872 — Correlation Between Vaspin Gene Polymorphism and Serum Vaspin Levels in Psoriasis Vulgaris · recruiting
NCT06398106 — Proactive TDM Versus Standard Use of Biologics in Psoriasis · Phase 4 · recruiting
NCT05185258 — Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study · Phase 4 · active not recruiting
NCT04950218 — Prevalence and Risk Factors asSOciated With CArdiac comorbiDIty in psoriAsis · recruiting

Other LEO Pharma trials

Trials by the same sponsor.

NCT07335588 — A 52-Week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream in Adult Participants With Lichen Sclerosus · Phase 3 · not yet recruiting
NCT07013201 — A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to · Phase 2 · recruiting
NCT06444867 — A Study to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of LEO 15896 · Phase 1 · completed
NCT06311682 — A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and · Phase 3 · recruiting
NCT05923099 — A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic De · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01536938 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by LEO Pharma
Last refreshed: 21 February 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01536938.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing