Who is sponsoring NCT01607853?

NCT01607853 is sponsored by LEO Pharma.

What condition does NCT01607853 study?

NCT01607853 studies Psoriasis Vulgaris.

Is NCT01607853 still recruiting?

NCT01607853 is currently completed. Last updated 21 February 2025.

Are results published for NCT01607853?

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

NCT01607853

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

A Phase IIa Exploratory Study Evaluating the Anti-psoriatic Effect of Daivobet® Gel Applied Then Removed After 10 Minutes, Daivobet® Gel Applied Then Removed After 20 Minutes, Daivobet® Gel Applied for 24 Hours and Daivobet® Gel Vehicle Applied for 24 Hours

Completed Phase 2 Results posted Last updated 21 February 2025

What this trial tests

Phase 2 trial testing Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) in Psoriasis Vulgaris in 24 participants. Completed in 1 October 2012.

Timeline

1 June 2012

Primary endpoint
1 October 2012

1 October 2012

Quick facts

Lead sponsor	LEO Pharma
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	other
Enrollment	24
Start date	1 June 2012
Primary completion	1 October 2012
Estimated completion	1 October 2012
Sites	1 location across France

Drugs / interventions tested

Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) — full drug profile →
Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) — full drug profile →
Daivobet® gel applied for 24 hours (+/- 2 hours) — full drug profile →
Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) — 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.

Change in Total Clinical Score From Baseline to Day 22
Time frame: baseline to day 22
Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clincal Score

Sponsor's own description

The purpose of this study is to evaluate the anti-psoriatic effect of Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) compared with Daivobet® gel and Daivobet® gel vehicle applied for 24 hours (+/- 2 hours), using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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 NCT01607853 (US National Library of Medicine, public domain)
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/NCT01607853.

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