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To evaluate SGX302 (topical hypericin ointment and gel) with visible light in an initial 18-week treatment course for improving lesions in patients with mild-to-moderate psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGX302 Ointment (0.25 % Hypericin) | Experimental | SGX302 (0.25 % hypericin) ointment will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks. |
|
| Placebo (Ointment without Hypericin) | Placebo Comparator | Placebo ointment will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks. |
|
| SGX302 Gel (0.25 % hypericin) | Experimental | SGX302 (0.25 % hypericin) gelt will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypericin | Drug | SGX302 is synthetic hypericin formulated as a 0.25% hypericin ointment or gel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients that achieve a 0 or 1 score using the 5-point Investigator's Global Assessment scale | The percentage of patients in each treatment group that achieve a 0 or 1 score (Clear or Almost Clear) evaluation using the 5-point Investigator's Global Assessment (IGA) scale. The 5-point IGA scale:
| 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients achieving a ≥75% improvement in Psoriasis Area and Severity Index | The percentage of patients in each treatment group that achieve a ≥75% improvement in Psoriasis Area and Severity Index (PASI 75). PASI is a combined assessment of lesion severity and affected area into a single score. The body is divided into 4 areas for scoring: head, arms, trunk and legs. Each area is scored by itself and scores are combined for a final PASI. For each area, scores of erythema, thickness and scale are scored on a scale of 0 (clear) to 4 (maximum). For each area, percent of skin involved is estimated: 0 = 0%, 1= 0 to ≤10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5 = 70 to ≤90%, 6 = 90 to100%. Final PASI = (sum of severity parameters for each area)*(area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Therapeutics Clinical Research | San Diego | California | 92123 | United States |
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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 |
|---|---|
| C004965 | hypericin |
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This is a 2 part study. All protocol procedures, timing for schedule of events and assessments are identical for Parts A and B. In Part A, 10-15 patients will be assigned open-label SGX302 (ointment or gel). Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, approximately 32 patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to a placebo.
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| Placebo | Drug | Placebo ointment is identical to SGX302 ointment (color matched) but it does not contain hypericin. |
|
| 18 weeks |
| Number of patients achieving a ≥90% improvement in Psoriasis Area and Severity Index | The percentage of patients in each treatment group that achieve a ≥90% improvement in Psoriasis Area and Severity Index (PASI 90). The calculation of PASI was previously described. | 18 weeks |
| Number of patients achieving a 100% improvement in Psoriasis Area and Severity Index | The percentage of patients in each treatment group that achieve a 100% improvement in Psoriasis Area and Severity Index (PASI 100). The calculation of PASI was previously described. | 18 weeks |