Back to resultsA Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products
Primary Purpose
Psoriasis Vulgaris
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
LEO 29102 cream
LEO 29102 Cream Vehicle
Betamethasone Dipropionate Cream
LEO 29102 Plus Calcipotriol Cream
LEO 29102 Plus Betamethasone Dipropionate
Daivobet® Ointment
Sponsored by
About this trial
This is an interventional other trial for Psoriasis Vulgaris
Eligibility Criteria
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
Sites / Locations
- LEO Pharma site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Active Comparator
Arm Label
LEO 29102 cream
LEO 29102 Cream Vehicle
Betamethasone Dipropionate Cream
LEO 29102 Plus Calcipotriol Cream
LEO 29102 Plus Betamethasone Dipropionate
Daivobet® Ointment
Arm Description
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
Outcomes
Primary Outcome Measures
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1)
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 Outcome Measures
Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline
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).
Change in Erythema Compared to Baseline
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
Change in Scaling Compared to Baseline
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
Change in Infiltration Compared to Baseline
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
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline
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).
Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound
The lesion thickness was measured by ultrasound at baseline, Day 8, Day 15, Day 22 and end of treatment.
Biomarkers by Immunochemistry
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.
Biomarkers by Immunochemistry: Epidermal Differentiation
3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement.
Biomarkers by Immunochemistry: Epidermal Proliferation
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.
Pathology and Histology by 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))
Pathology and Histology by Treatment: Epidermal Thickness
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..
Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00875277
Brief Title
A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LEO 29102 cream
Arm Type
Experimental
Arm Description
LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks
Arm Title
LEO 29102 Cream Vehicle
Arm Type
Placebo Comparator
Arm Description
LEO 29102 cream vehicle applied topically twice daily for 4 weeks.
Arm Title
Betamethasone Dipropionate Cream
Arm Type
Experimental
Arm Description
Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
Arm Title
LEO 29102 Plus Calcipotriol Cream
Arm Type
Experimental
Arm Description
LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks.
Arm Title
LEO 29102 Plus Betamethasone Dipropionate
Arm Type
Experimental
Arm Description
LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks.
Arm Title
Daivobet® Ointment
Arm Type
Active Comparator
Arm Description
Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
LEO 29102 cream
Intervention Type
Drug
Intervention Name(s)
LEO 29102 Cream Vehicle
Intervention Type
Drug
Intervention Name(s)
Betamethasone Dipropionate Cream
Intervention Type
Drug
Intervention Name(s)
LEO 29102 Plus Calcipotriol Cream
Intervention Type
Drug
Intervention Name(s)
LEO 29102 Plus Betamethasone Dipropionate
Intervention Type
Drug
Intervention Name(s)
Daivobet® Ointment
Primary Outcome Measure Information:
Title
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1)
Description
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).
Time Frame
From baseline (Day 1) to end of treatment (Day 29)
Secondary Outcome Measure Information:
Title
Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline
Description
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).
Time Frame
From baseline (Day 1) to end of treatment (Day 29)
Title
Change in Erythema Compared to Baseline
Description
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
Time Frame
At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25
Title
Change in Scaling Compared to Baseline
Description
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
Time Frame
At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25
Title
Change in Infiltration Compared to Baseline
Description
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
Time Frame
At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25
Title
Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline
Description
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).
Time Frame
At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25
Title
Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound
Description
The lesion thickness was measured by ultrasound at baseline, Day 8, Day 15, Day 22 and end of treatment.
Time Frame
At Day 8, Day 15, Day 22 and end of treatment
Title
Biomarkers by Immunochemistry
Description
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.
Time Frame
At end of treatment
Title
Biomarkers by Immunochemistry: Epidermal Differentiation
Description
3 skin biopsies (punch biopsies of 3 mm) per participant were taken on Day 29 after the clinical scoring and ultrasound measurement.
Time Frame
At end of treatment
Title
Biomarkers by Immunochemistry: Epidermal Proliferation
Description
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.
Time Frame
At end of treatment
Title
Pathology and Histology by Treatment
Description
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))
Time Frame
At end of treatment
Title
Pathology and Histology by Treatment: Epidermal Thickness
Description
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..
Time Frame
At end of treatment
Title
Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses
Description
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.
Time Frame
At end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Director, International Clinical Development, MD
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
LEO Pharma site
City
Saint-Quentin-en-Yvelines
Country
France
12. IPD Sharing Statement
Learn more about this trial
A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products
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