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Completed

NCT Number: NCT01580488

A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

The purpose of the study is to evaluate the anti-psoriatic effect of LEO 35299 in different formulations, compared to Daivonex® ointment and Daivonex® ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière

Nice, 06202, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out.
  • Age 18 years or above.
  • Males, or females of non-child bearing potential.
  • Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (Baseline).

Exclusion criteria

  • Male subjects who are not willing to use a local contraception (such as condom) from the time of study entry and for three months following the last study drug application.
  • Female subjects who are pregnant, of child-bearing potential 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 islonger) 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, immune suppressants) 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.
  • Subjects using of phototherapy within the following time periods prior to randomisation and during the study:
  • PUVA (4 weeks)
  • UVB (2 weeks)
  • 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.
  • Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
  • Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history and/or subject interview
  • Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments)
  • Subjects with current participation in any other interventional clinical, based on interview of the subject

Treatment and study plan

B LEO 35299 20 mg/g cream

Drug

once daily application, 3 weeks

C LEO 35299 20 mg/g cream

Drug

once daily application, 3 weeks

E LEO 35299 10 mg/g solution

Drug

once daily application, 3 weeks

F LEO 35299 10 mg/g solution

Drug

once daily application, 3 weeks

Daivonex® ointment

Drug

once daily application, 3 weeks

Daivonex® ointment vehicle

Drug

once daily application, 3 weeks

Primary outcomes

  1. Change in the 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 Clinical Score. Total Clinical Score range from 0 (all symptoms absent) to 9 (all symptoms severe)

Secondary outcomes

  1. Change in Erythema From Baseline to Day 22

    Time frame: Baseline to Day 22

    Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).

  2. Change in Infiltration From Baseline to Day 22

    Time frame: Baseline to Day 22

    Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).

  3. Change in Scaling From Baseline to Day 22

    Time frame: Baseline to Day 22

    Investigator's rating of the clinical appearance of scaling . Maximum score is 3 (most severe); minimum score is 0 (absent).

  4. Change in Lesion Thickness From Baseline to Day 22

    Time frame: Baseline to Day 22

    Change in total skin thickness measured by ultrasound from baseline to end of treatment

  5. Change in Skin Thickness From Baseline to Day 22

    Time frame: Baseline to Day 22

    Change in skin thickness - echo-poor band measured by ultrasound from baseline to end of treatment

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 19, 2012
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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