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Completed

NCT Number: NCT00845481

A Plaque Test Comparing the Anti-psoriatic Effect of Marketed Products for Topical Use for Psoriasis Vulgaris

The purpose of the study is to compare the anti-psoriatic effect of marketed products with Daivobet® ointment in a plaque test

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Key information

Conditions

Psoriasis Vulgaris

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

LEO Pharma Investigational Site

Saint Quentin Yvelines Cedex, 78054, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(in summary)

  • Subjects having understood and signed an informed consent form
  • All skin types
  • Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk. The lesions must have a total size suitable for application. The subjects should be asked if their lesions have been stable
  • Subjects willing and able to follow all the study procedures and complete the whole study
  • Subjects affiliated to social security system

Exclusion criteria

(in summary)

  • Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
  • Subjects using biological therapies (marketed or not marketed) with a possible effect on psoriasis (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to study drug administration
  • Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D-analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
  • Subjects using one of the following topical drugs for the treatment of psoriasis within four (4) weeks prior to study drug administration: - 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 (2) weeks prior to study drug administration: - WHO group I-II corticosteroids - Topical retinoids - Vitamin D-analogues - Topical immunomodulators (e.g. macrolides) - Anthracen derivatives - Tar - Salicylic acid - UVB therapy
  • Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas

Treatment and study plan

Daivobet® Ointment

Drug

Once daily application 6 days a week for 3 weeks

Betnovat® ointment

Drug

Once daily application 6 days a week for 3 weeks

Diprosalic ointment

Drug

Once daily application 6 days a week for 3 weeks

Dermovat ointment

Drug

Once daily application 6 days a week for 3 weeks

Elocon ointment

Drug

Once daily application 6 days a week for 3 weeks

Daivobet® ointment vehicle

Drug

Once daily application 6 days a week for 3 weeks

Primary outcomes

  1. The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet® Ointment

    Time frame: Baseline and 3 weeks

    The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

  2. The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Betnovat® Ointment

    Time frame: Baseline and 3 weeks

    The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

  3. The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Elocon Ointment

    Time frame: Baseline and 3 weeks

    The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

  4. The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Daivobet Ointment Vehicle

    Time frame: Baseline and 3 weeks

    The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

  5. The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Dermovat Ointment

    Time frame: Baseline and 3 weeks

    The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

  6. The Absolute Change in Total Clinical Score (TCS) at End of Treatment Compared to Baseline for Diprosalic Ointment

    Time frame: Baseline and 3 weeks

    The Total Clinical Score is the sum of three psoriasis scores (redness, thickness, and scaliness) and will range from 0 (best) to 9 (worst)

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

A Plaque Test Comparing 4 Steroids With Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 18, 2009
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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