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The purpose of this study is to assess the safety, tolerability and clinical activity of the SHP-141C topical cream formulations in patients with plaque type psoriasis.
Psoriasis is a chronic, relapsing immunoinflammatory disorder. Chronic plaque psoriasis is the most common (85% - 90%) type. Cutaneous features of individual plaques include circular with centrifugal expansion, induration with sharp demarcation from surrounding skin, erythema and hyperkeratosis. Psoriasis has a negative impact on physical and mental aspects of life that is similar to other major chronic conditions. The modalities of psoriasis treatments can be divided into four main categories: topical, phototherapy, systemic drug therapies and systemic biological treatments. The currently available treatments for psoriasis result in either disease suppression or disease remission.There are many treatment options for the management of psoriasis using topical modalities; however all are lacking with respect to patient satisfaction and durability of treatment. Most current topical treatments, and many treatments in development, are based on modifications of a steroid structure or on Vitamin D. Recent research has identified a broad role for histone deacetylase (HDAC) proteins in numerous signaling pathways critical to cancer cell survival, such as epigenetic inheritance, gene regulation, mitosis,signal transduction and importantly, inflammation. Theoretically modulation of HDAC could lead to clinical benefit in inflammatory diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHP-141C & Placebo & Calcipotriol & Betamethasone Valerate | Experimental | A 100 mg dose of SHP-141C cream at three concentrations (0.5%, 1.0% and 2.0%), a matched placebo cream and two reference treatments: Calcipotriol 0.005% cream and Betamethasone Valerate 0.02% cream, applied topically to a selected plaque on each subject, six times per week over 28 days for a total of 24 doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHP-141C | Drug | Topical Cream |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Local Plaque Severity Index (LPSI) | Measurement of plaque severity including erythema, induration, and desquamation. | Baseline, day 15, day 33 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients with adverse events | Adverse event data for each subject will be collected. | daily to and including Day33 |
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Inclusion Criteria:
Exclusion Criteria:
Dermatological Conditions
Concurrent Medical Conditions
Laboratory Status
Treatment with any of the following within 4 weeks prior to the commencement of study treatment and for the duration of the study:
Topical treatment of the 2 target lesions with any of the following within 2 weeks prior to commencement of study treatment and for the duration of the study
Concurrent Medications Subjects have received or anticipate receiving a new medicine (prescription, over-the-counter or herbal), given systemically or topically, within 14 days prior to the start of dosing. Subjects may be enrolled if stable on existing therapy (having been on it for at least 60 days) as determined by the Principal Investigator.
Hypersensitivity History of allergy and/or hypersensitivity to any of the stated ingredients of the formulations or other topical agents. A known hypersensitivity to lignocaine, or all surgical dressings that may be used in the study procedures.
Females who are lactating, pregnant or planning to become pregnant.
Drug and Alcohol Abuse History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit, or positive urine drug and alcohol screen for drugs of abuse and alcohol.
Psychiatric Disorder History of any psychiatric illness which may impair the ability to provide written informed consent
Participation in a research study within 30 days of the start of dosing.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Foley | The Alfred | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Limited | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001624 | Betamethasone Valerate |
| C055085 | calcipotriene |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Placebo to SHP-141C | Drug | Placebo Topical Cream |
|
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| Betamethasone Valerate | Drug | Topical cream, 0.02% |
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| Calcipotriol | Drug | Topical cream, 0.005% |
|
|
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |