NCT01297166

Brief Summary

The purpose of this study is to evaluate the anti-psoriatic effect of LEO 27989 ointment and calcipotriol plus LEO 27989 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
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_1

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

February 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

February 24, 2025

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

February 3, 2011

Last Update Submit

February 21, 2025

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Absolute change in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration) at end of treatment compared to baseline.

    TCS range from 0 (all symptoms absent) to 9 (all symptoms severe)

    3 weeks

Secondary Outcomes (4)

  • Clinical sympton scores

    3 weeks

  • Lesion thickness

    3 weeks

  • Immunohistochemical and histologic scoring of biopsy material

    3 weeks

  • Intra-subject variability

    3 weeks

Study Arms (1)

LEO 27989 ointment

EXPERIMENTAL
Drug: LEO 27989 ointmentDrug: Calcipotriol plus LEO 27989 ointmentDrug: Calcipotriol ointmentDrug: Vehicle ointment

Interventions

LEO 27989 ointmentDRUG

once daily application, 3weeks

LEO 27989 ointment
Calcipotriol plus LEO 27989 ointmentDRUG

once daily application, 3weeks

LEO 27989 ointment
Calcipotriol ointmentDRUG

once daily application, 3weeks

LEO 27989 ointment
Vehicle ointmentDRUG

once daily application, 3weeks

LEO 27989 ointment

Eligibility Criteria

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

You may qualify if:

  • Subjects having understood and signed an informed consent form
  • Age 18 years or above
  • Males, or females of non-child bearing potential
  • All skin types
  • Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms and/or legs and/or trunk.

You may not qualify if:

  • Male who are not willing to use a local contraception (such as condom) for the entire duration of the study, and refrain from fathering a child within 3 months following the last study drug application
  • 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
  • Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study:
  • Potent or very potent (WHO group III-IV) corticosteroids
  • PUVA or Grenz ray therapy
  • Subjects using one of the following topical drugs for the treatment of psoriasis within two 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. macrolides)
  • Anthracen derivatives
  • Tar
  • Salicylic acid
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CPCAD

Nice, France

Location

MeSH Terms

Interventions

calcipotriene

Study Officials

  • Catherine Queille-Roussel, MD

    Centre de Pharmacologie Clinique Applique a la Dermatologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2011

First Posted

February 16, 2011

Study Start

February 1, 2011

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

February 24, 2025

Record last verified: 2013-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)