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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005349-11 | EudraCT Number |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Total Clinical Score From 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) | Baseline to Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Erythema From Baseline to Day 22 | Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent). | Baseline to Day 22 |
| Change in Infiltration From Baseline to Day 22 |
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Inclusion Criteria:
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:
Subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study:
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
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Queille-Roussel, MD | Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD), Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière 06202 Nice Cedex 3, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière | Nice | 06202 | France |
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Prior to randomisation, the subjects entered a washout phase of up to 21 days (if required) where antipsoriatic treatment and other relevant medications or treatments had to be discontinued as defined by the exclusion criteria
First subject first visit, start date: 24-Apr-2012 Last subject last visit, completion date: 05-Jun-2012
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Each of the 24 subjects received all 6 investigational products on small dermal test sites: Topical cream formulation "B" containing 20 mg/g LEO 35299 Topical cream formulation "C" containing 20 mg/g LEO 35299 Topical solution formulation "E" containing 10 mg/g LEO 35299 Topical solution formulation "F" containing 10 mg/g LEO 35299 Topical ointment containing 50 mcg/g calcipotriol Topical ointment vehicle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Total Clinical Score From 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 22 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | B LEO 35299 20 mg/g | Topical cream formulation "B" containing 20 mg/g LEO 35299 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 6.1 | Non-systematic Assessment |
This was an exploratory study in which each of the 24 subjects received all 6 treatments on 2 cm diameter dermal test sites. Regarding Adverse Events, only local dermal reactions could be potentially attributed to a specific treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | LEO Pharma A/S | +45 4494 5888 | ctr.disclosure@leo-pharma.com |
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| ID | Term |
|---|---|
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).
| Baseline to Day 22 |
| Change in Scaling From Baseline to Day 22 | Investigator's rating of the clinical appearance of scaling . Maximum score is 3 (most severe); minimum score is 0 (absent). | Baseline to Day 22 |
| Change in Lesion Thickness From Baseline to Day 22 | Change in total skin thickness measured by ultrasound from baseline to end of treatment | Baseline to Day 22 |
| Change in Skin Thickness From Baseline to Day 22 | Change in skin thickness - echo-poor band measured by ultrasound from baseline to end of treatment | Baseline to Day 22 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | E LEO 35299 10 mg/g | Topical solution formulation "E" containing 10 mg/g LEO 35299 |
| OG003 | F LEO 35299 10 mg/g | Topical solution formulation "F" containing 10 mg/g LEO 35299 |
| OG004 | Daivonex® Ointment: Calcipotriol 50 mcg/g Ointment | Topical ointment containing 50 mcg/g calcipotriol |
| OG005 | Daivonex® Ointment | Topical ointment vehicle |
|
|
| Secondary | Change in Erythema From Baseline to Day 22 | Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent). | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 22 |
|
|
|
| Secondary | Change in Infiltration From Baseline to Day 22 | Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent). | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 22 |
|
|
|
| Secondary | Change in Scaling From Baseline to Day 22 | Investigator's rating of the clinical appearance of scaling . Maximum score is 3 (most severe); minimum score is 0 (absent). | Posted | Mean | Standard Deviation | units on a scale | Baseline to Day 22 |
|
|
|
| Secondary | Change in Lesion Thickness From Baseline to Day 22 | Change in total skin thickness measured by ultrasound from baseline to end of treatment | Posted | Mean | Standard Deviation | millimeters | Baseline to Day 22 |
|
|
|
| Secondary | Change in Skin Thickness From Baseline to Day 22 | Change in skin thickness - echo-poor band measured by ultrasound from baseline to end of treatment | Posted | Mean | Standard Deviation | millimeters | Baseline to Day 22 |
|
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| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | C LEO 35299 20 mg/g | Topical cream formulation "C" containing 20 mg/g LEO 35299 | 0 | 24 | 0 | 24 |
| EG002 | E LEO 35299 10 mg/g | Topical solution formulation "E" containing 10 mg/g LEO 35299 | 0 | 24 | 0 | 24 |
| EG003 | F LEO 35299 10 mg/g | Topical solution formulation "F" containing 10 mg/g LEO 35299 | 0 | 24 | 0 | 24 |
| EG004 | Daivonex® Ointment: Calcipotriol 50 mcg/g Ointment | Topical ointment containing 50 mcg/g calcipotriol | 0 | 24 | 2 | 24 |
| EG005 | Daivonex® Ointment | Topical ointment vehicle | 0 | 24 | 1 | 24 |
The sponsor is entitled to review and comment on publications prior to submission or presentation. Upon request of the sponsor, the investigator shall delay publication or presentation to allow for protection of the sponsors inventions and other intellectual property.