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| Name | Class |
|---|---|
| Tribute Pharmaceuticals | INDUSTRY |
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This pilot, phase II, 24-week study will recruit a total of 10 patients and will evaluate the efficacy and safety of acitretin in patients with severe chronic hand dermatitis .
Patients will receive acitretin once daily for a maximum of 24 weeks. Patients who reach a Physician Global Assessment (PGA) of clear or almost clear at week 12 will end the study. Patients who do not reach a PGA of clear or almost clear at week 12 will continue treatment up to week 24. The starting dose will be 10mg/day and, if well tolerated, will be increased in the first 4 weeks to a maximum of 30 mg/day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acitretin | Experimental | Patients will receive acitretin once daily for a maximum of 24 weeks. Patients who reach a Physician Global Assessment (PGA) of clear or almost clear at week 12 will end the study. Patients who do not reach a PGA of clear or almost clear at week 12 will continue treatment up to week 24. The starting dose will be 10mg/day and, if well tolerated, it will be increased in the first 4 weeks to a maximum of 30 mg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acitretin | Drug | All patients will receive open-label single oral acitretin 10 mg capsule once daily as a starting dose. If well tolerated, the dose will be increased in the first 4 weeks to a maximum of 30mg/day. Patients will be instructed to take the treatment as a single oral dose with a meal. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who reach a Physician Global Assessment (PGA) of clear or almost clear at the end of therapy. | 12-24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who reach a partial response defined as a PGA of clear, almost clear or mild at the end of therapy | 12-24 weeks | |
| Change from baseline in modified Total Lesion Symptom Score (mTLSS) at the end of therapy | 12-24 weeks |
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Inclusion Criteria:
Effective contraceptive methods are:
Barrier methods such as condom, sponge or diaphragm combined with spermicide in foam, gel or cream
Female partner: Hormonal contraception (oral, intramuscular, implant or transdermal) which include Depo-Provera, Evra and Nuvaring. Oral contraceptives must have been taken at a stable dose for at least 90 days before study start
Female partner: Intrauterine device (IUD)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bissonnette, MD, FRCPC | Innovaderm Research Inc. | Principal Investigator |
| Jerry Tan, MD, FRCPC | Windsor Clinical Research Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Windsor Clinical Research Inc. | Windsor | Ontario | N8W 5L7 | Canada | ||
| Innovaderm Research Inc. |
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| ID | Term |
|---|---|
| D017255 | Acitretin |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| Mean time to response defined as the number of days between baseline and the time the patient reaches a PGA of clear or almost clear | 24 weeks |
| Mean Patient Global Assessment (PaGA) at the end of therapy | 12-24 weeks |
| Change from baseline in extent of disease at the end of therapy | 12-24 weeks |
| Type, severity and relationship of adverse events | 12-24 weeks |
| Montreal |
| Quebec |
| H2K 4L5 |
| Canada |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |