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| ID | Type | Description | Link |
|---|---|---|---|
| IR.FUMS.REC.1400.125 | Other Identifier | Fasaums |
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| Name | Class |
|---|---|
| Zarrin Avaye Kowsar Salamat (ZAX company) and HerbmedX | UNKNOWN |
| Herbmedx Co | INDUSTRY |
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The goal of this interventional clinical trial study is to compare ZAX.1400.P03 and placebo in Psoriasis patients. The main question it aims to answer is:
• Can treatment with ZAX.1400.P03 for 3 weeks improve clinical signs of skin in psoriasis patients? Participants will be divided into two groups of 52 people. One group will use ZAX.1400.P03 topically twice daily for 3 weeks and the other group will use placebo topically twice daily for 3 weeks.
Researchers will compare treatment and placebo groups to see if there is any improvement in the clinical signs of skin caused by psoriasis after treatment with ZAX.1400.P03 for 3 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical ZAX.1400.P03 | Experimental | ZAX.1400.P03, applied topically twice daily for 3 weeks after enrolment |
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| Placebo | Placebo Comparator | Placebo, applied topically twice daily for 3 weeks after enrolment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZAX.1400.P03 | Dietary Supplement | ZAX.1400.P03, applied twice daily for 3 weeks after enrolment |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Dermatology Life Quality Index (DLQI) score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | DLQI score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Percent Body Surface Area (%BSA) at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis. BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared %Body Surface Area Affected the "Rule of Nine" was be used |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fasa university of medical sciences | Fasa | Fars | 7461686688 | Iran |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D007249 | Inflammation |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Drug | Placebo, applied twice daily for 3 weeks after enrolment |
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| Baseline and Weeks 1, 2, 3, 4, 5, and 6 |
| Change From Baseline in erythema score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Erythema score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 |
| Change From Baseline in Swelling score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Swelling score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 |
| Change From Baseline in pruritus score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Pruritus score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 |
| Change From Baseline in flake score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Flake score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 |
| Change From Baseline in skin dryness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Skin dryness score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 |
| Change From Baseline in skin irritation score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Skin irritation score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 |
| Change From Baseline in pain score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Pain score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 |
| Change From Baseline in skin scratch score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Skin scratch score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 |
| Change From Baseline in skin scar score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Skin scar score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 |
| Change From Baseline in skin thickness score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Skin thickness score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 |
| Change From Baseline in skin rashes score at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Skin rashes score will be assessed at Day0 (Baseline), Day7, Day14, Day21, Day28, Day35, and Day42 | Baseline and Weeks 1, 2, 3, 4, 5, and 6 |