NCT01347255

Brief Summary

The purpose of the study is to evaluate the anti-psoriatic effect of LEO 90100 cutaneous spray ointment, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2011

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

February 24, 2016

Completed
Last Updated

March 7, 2025

Status Verified

July 1, 2016

Enrollment Period

1 month

First QC Date

May 3, 2011

Results QC Date

November 13, 2015

Last Update Submit

February 21, 2025

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline

    TCS range from 0 (all signs absent) to 9 (all signs severe).

    Day 1 (Baseline)/Day 29

Secondary Outcomes (4)

  • Change in Clinical Sign Scores

    Baseline and Days 4, 8, 11, 15, 18, 22, 25, and 29 (End of Treatment)

  • Changes in Total Clinical Score (TCS) by Visit

    Baseline and Days 4, 8, 11, 15, 18, 22, 25

  • Change From Baseline in Echo-poor Band Thickness at End of Treatment

    Baseline and Day 29

  • Changes in Total Skin Thickness

    Baseline and Days 8, 15, 22, and 29.

Study Arms (4)

LEO 90100 cutaneous spray ointment

EXPERIMENTAL

LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).

Drug: LEO90100 cutaneous spray, ointment

LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone

ACTIVE COMPARATOR

Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)

Drug: LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate

LEO 90100 Cutaneous Spray, Ointment, Vehicle

PLACEBO COMPARATOR

LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.

Drug: LEO 90100 cutaneous spray, ointment, vehicle

Daivobet® Ointment

ACTIVE COMPARATOR

Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)

Drug: Daivobet® ointment

Interventions

LEO90100 cutaneous spray, ointmentDRUG

once daily application, 4 weeks

LEO 90100 cutaneous spray ointment
LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionateDRUG

once daily application, 4 weeks

LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone
LEO 90100 cutaneous spray, ointment, vehicleDRUG

once daily application, 4 weeks

LEO 90100 Cutaneous Spray, Ointment, Vehicle
Daivobet® ointmentDRUG

once daily application, 4 weeks

Also known as: Taclonex® ointment
Daivobet® Ointment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects having signed and dated an informed consent
  • Age 18 years or above
  • Either sex
  • All skin types
  • Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk.

You may not qualify if:

  • Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
  • Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer)for experimental biological products prior to randomisation and during the study
  • Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4- week period prior to randomisation and during the study
  • Use of phototherapy within the following time periods prior to randomisation and during the study:
  • PUVA or Grenz ray therapy (4 weeks)
  • UVB (2 weeks)
  • Subjects using one of the following topical drugs within 4 weeks prior to randomisation and during the study:
  • Potent or very potent (WHO group III-IV) corticosteroids
  • Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the study:
  • WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)
  • Topical retinoids
  • Vitamin D analogues
  • Topical immunomodulators (e.g. calcineurin inhibitors)
  • Anthracen derivatives
  • Tar
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)

Nice, Cedex 3, France

Location

Related Publications (3)

  • Queille-Roussel C, Olesen M, Villumsen J, Lacour JP. Efficacy of an innovative aerosol foam formulation of fixed combination calcipotriol plus betamethasone dipropionate in patients with psoriasis vulgaris. Clin Drug Investig. 2015 Apr;35(4):239-45. doi: 10.1007/s40261-015-0269-7.

    PMID: 25708531RESULT

  • Queille-Roussel C, Olesen M, Villumsen J, Lacour JP. Antipsoriatic effect of a novel aerosol foam formulation of the fixed combination calcipotriene plus betamethasone dipropionate in patients with psoriasis, using a modified psoriasis plaque test. Semin Cutan Med Surg. 2015;34 S1:PA-10.

    RESULT

  • Hollesen Basse L, Olesen M, Lacour J, Queille-Roussel C. Enhanced in vitro skin penetration and antipsoriatic effect of fixed combination calcipotriol plus betamethasone dipropionate in an innovative foam vehicle. J Invest Dermatol. 2014;134:S33(abst 192).

    RESULT

MeSH Terms

Interventions

Ointmentsbetamethasone-17,21-dipropionate

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Clinical Trial Disclosure Manager
Organization
LEO Pharma A/S
ctr.disclosure@leo-pharma.com
+45 44945888

Study Officials

  • Catherine Queille-Roussel, MD

    Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD), Hôpital l'Archet 2, 06202 Nice Cedex 3, France

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2011

First Posted

May 4, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 7, 2025

Results First Posted

February 24, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)