NCT00216840

Brief Summary

The purpose of the study is to evaluate whether once daily topical treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle and calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis. The primary response criterion is the number of patients with absence of disease and very mild disease after 8 weeks of treatment.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
1,350

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_3

Geographic Reach
7 countries

7 active sites

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

December 1, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

February 24, 2025

Status Verified

March 1, 2015

First QC Date

September 15, 2005

Last Update Submit

February 21, 2025

Conditions

Psoriasis of Scalp

Outcome Measures

Primary Outcomes (1)

  • - Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 8.

Secondary Outcomes (6)

  • - Total sign score at week 8

  • - Score for scaliness, redness and thickness at week 8

  • - Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 2 and 4

  • - Patients with "Treatment success" ("Almost clear" or "Cleared") according to patient's overall assessment of disease severity at week 8

  • - Evaluation of Adverse Events

  • +1 more secondary outcomes

Interventions

Calcipotriol plus betamethasone dipropionate (LEO80185 gel)DRUG

Eligibility Criteria

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

You may qualify if:

  • Scalp psoriasis amenable to topical treatment with a maximum of 100 g of medication per week
  • Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs
  • Extent of scalp psoriasis involving more than 10% of the total scalp area
  • Investigator's assessment of clinical signs of the scalp of at least 2 in one of the clinical signs, erythema, thickness and scaliness, and at least 1 in each of the other two clinical signs
  • Disease severity on the scalp graded as Mild, Moderate, Severe or Very severe according to the investigator's global assessment of disease severity

You may not qualify if:

  • PUVA or Grenz ray therapy within 4 weeks prior to randomisation
  • UVB therapy within 2 weeks prior to randomisation
  • Systemic treatment with biological therapies, with a possible effect on scalp psoriasis within 6 months prior to randomisation
  • Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation
  • Any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation
  • Topical treatment of the face, trunk and/or limbs with very potent WHO group IV corticosteroids within 2 weeks prior to randomisation
  • Current diagnosis of erythrodermic, exfoliative or pustular psoriasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Universitair Ziekenhuis Sint Rafaël, Dienst Dermatologie

Leuven, BE-3000, Belgium

Location

Innovaderm Research Inc.

Montreal, Quebec, H2K 4L5, Canada

Location

Policlinic of Dermatology, Medical Reception Centre

Turku, SF-20100, Finland

Location

Hôpital Trousseau, Service de Dermatologie CHU Tours

Tours, F-37044, France

Location

Georg-August-Universität Göttingen, Abteilung Dermatologie und Venerologie

Göttingen, D-37075, Germany

Location

Universitair Medisch, Centrum St. Radboud, Afdeling Dermatologie

Nijmegen, NL-6525, Netherlands

Location

Royal Gwent Hospital, Department of Dermatology

Newport, NP20 2UB, United Kingdom

Location

Related Publications (1)

  • van de Kerkhof PC, Hoffmann V, Anstey A, Barnes L, Bolduc C, Reich K, Saari S, Segaert S, Vaillant L. A new scalp formulation of calcipotriol plus betamethasone dipropionate compared with each of its active ingredients in the same vehicle for the treatment of scalp psoriasis: a randomized, double-blind, controlled trial. Br J Dermatol. 2009 Jan;160(1):170-6. doi: 10.1111/j.1365-2133.2008.08927.x. Epub 2008 Nov 25.

    PMID: 19067709DERIVED

Related Links

MeSH Terms

Interventions

calcipotrienebetamethasone-17,21-dipropionate

Study Officials

  • Peter van de Kerkhof, MD

    Universitair Medisch, Afdeling Dermatologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

December 1, 2004

Study Completion

September 1, 2005

Last Updated

February 24, 2025

Record last verified: 2015-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)GB(1)NL(1)CA(1)BE(1)FR(1)FI(1)