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Completed

NCT Number: NCT00875277

A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products

The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.

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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 site

Saint-Quentin-en-Yvelines, 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

LEO 29102 cream

Drug

LEO 29102 Cream Vehicle

Drug

Betamethasone Dipropionate Cream

Drug

LEO 29102 Plus Calcipotriol Cream

Drug

LEO 29102 Plus Betamethasone Dipropionate

Drug

Daivobet® Ointment

Drug

Primary outcomes

  1. Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1)

    Time frame: From baseline (Day 1) to end of treatment (Day 29)

    The (sub)investigator made the following clinical assessments by use of the scale below:

    Score; Intensity; Description

    Erythema:

    0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red

    Scaling:

    0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales

    Infiltration:

    0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration

    The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe).

Secondary outcomes

  1. Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline

    Time frame: From baseline (Day 1) to end of treatment (Day 29)

    The (sub)investigator made the following clinical assessments by use of the scale below:

    Score; Intensity; Description

    Erythema:

    0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red

    Scaling:

    0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales

    Infiltration:

    0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe).

  2. Change in Erythema Compared to Baseline

    Time frame: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25

    The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale.

    The (sub)investigator made the following clinical assessments by use of the scale below:

    Score; Intensity; Description

    Erythema:

    0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red

  3. Change in Scaling Compared to Baseline

    Time frame: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25

    The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale.

    The (sub)investigator made the following clinical assessments by use of the scale below:

    Score; Intensity; Description

    Scaling:

    0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales

  4. Change in Infiltration Compared to Baseline

    Time frame: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25

    The severity of the symptoms was rated on screening and on study Days 1 (baseline), 4, 8, 11, 15, 18, 22, 25 and 29 (end of treatment) according to the 0-3 with half-point TCS grading scale.

    The (sub)investigator made the following clinical assessments by use of the scale below:

    Score; Intensity; Description

    Infiltration:

    0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration

  5. Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline

    Time frame: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25

    The (sub)investigator made the following clinical assessments by use of the scale below:

    Score; Intensity; Description

    Erythema:

    0; No evidence; Normal skin color 0.5; Doubtful or very mild 1.0; Mild; Pink light red 1.5; Mild to moderate 2.0; Moderate; Red 2.5; Moderate to severe 3.0; Severe; Intense red

    Scaling:

    0; No evidence; No scaling 0.5; Doubtful or very mild 1.0; Mild; Slight roughness, mainly fine scales 1.5; Mild to moderate 2.0; Moderate; Coarse scaling 2.5; Moderate to severe 3.0; Severe; Coarse, thick scales

    Infiltration:

    0; No evidence 0.5; Doubtful or very mild 1.0; Mild Slight definite infiltration 1.5; Mild to moderate 2.0; Moderate; Moderate infiltration 2.5; Moderate to severe 3.0; Severe; Very marked infiltration

    The TCS was defined as the sum of erythema plus scaling plus thickness scores. The TCS therefore ranged from 0 (all symptoms absent) to 9 (all symptoms severe).

  6. Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound

    Time frame: At Day 8, Day 15, Day 22 and end of treatment

    The lesion thickness was measured by ultrasound at baseline, Day 8, Day 15, Day 22 and end of treatment.

  7. Biomarkers by Immunochemistry

    Time frame: At end of treatment

    3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement.

    Cells counted per mm^2 were cells that were positive for the indicated biomarker.

  8. Biomarkers by Immunochemistry: Epidermal Differentiation

    Time frame: At end of treatment

    3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement.

  9. Biomarkers by Immunochemistry: Epidermal Proliferation

    Time frame: At end of treatment

    3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement.

    By measurement of the cell-cycle marker, Ki-67 protein, an evaluation of the degree of skin cell proliferation and thereby epidermal proliferation could be obtained. Cells counted per mm^2 were cells that were positive for the indicated biomarker.

  10. Pathology and Histology by Treatment

    Time frame: At end of treatment

    Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. The extent of the following parameters were measured in scored semi-quantitatively (semi) on blinded haematoxylin and eosin (HE) sections. Semi-quantitative scoring was categorized as No (0), mild (1), moderate (2), marked (3) or severe (4). In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum) the tissue was classified by the characteristics seen below:

    • Morphology of epidermis
    • Stratum corneum (semi (extent of))
    • Stratum granulosum (semi (extent of))
    • Parakeratosis (semi (extent of))
    • Infiltration of inflammatory cells (semi (extent of))

  11. Pathology and Histology by Treatment: Epidermal Thickness

    Time frame: At end of treatment

    Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study. In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum), the tissue was classified by the characteristic epidermal thickness. This was measured in the absolute number of µm measured on blinded haematoxylin and eosin (HE) sections..

  12. Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses

    Time frame: At end of treatment

    Skin biopsies were taken on Day 29. The evaluation of immunohistochemical sections were performed on cross sections of the skin tissue. The same pathologist did all evaluations, and samples were masked to ensure a blind fashion study.

    In evaluating the morphology of epidermis (Stratum corneum and Stratum granulosum), the tissue was classified by the characteristic of frequency of neutrophil microabscesses (Monroe´s abscess). This was measured in absolute number of cells that were positive for the marker on blinded haematoxylin and eosin (HE) sections.

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

A Psoriasis Plaque Test Comparing LEO 29102 Cream and Its Different Combinations to 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
Apr 3, 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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