Topical SGX302 for Mild-to-Moderate Psoriasis
Study Details
Study Description
Brief Summary
To evaluate SGX302 (topical hypericin ointment) with visible light in an initial 18-week treatment course for improving lesions in patients with mild-to-moderate psoriasis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SGX302 (Ointment with 0.25 % Hypericin) 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. |
Drug: Hypericin
SGX302 is synthetic hypericin formulated as a 0.25% hypericin ointment.
Other Names:
|
| Placebo Comparator: Placebo (Ointment without Hypericin) 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. |
Drug: Placebo
Placebo ointment is identical to SGX302 ointment (color matched) but it does not contain hypericin.
|
Outcome Measures
Primary Outcome Measures
- Number of patients that achieve a 0 or 1 score using the 5-point Investigator's Global Assessment scale [18 weeks]
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: Score 0: Clear - No signs of psoriasis; post-inflammatory hyperpigmentation may be present Score 1: Almost Clear - No thickening; normal to pink coloration; no to minimal focal scaling Score 2: Mild - Just detectable to mild thickening; pink to light red coloration; predominantly fine scaling Score 3: Moderate - Clear distinguishable to moderate thickening; dull to bright red; moderate scaling Score 4: Severe - Severe thickening with hard edges; bright to deep red coloration; severe/coarse scaling covering almost all lesions
Secondary Outcome Measures
- Number of patients achieving a ≥75% improvement in Psoriasis Area and Severity Index [18 weeks]
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)).
- Number of patients achieving a ≥90% improvement in Psoriasis Area and Severity Index [18 weeks]
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.
- Number of patients achieving a 100% improvement in Psoriasis Area and Severity Index [18 weeks]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6-months duration that involves the body (trunk and/or limbs) that is amenable to topical treatment and opaque coverage after application.
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Have a static Investigator Global Assessment (IGA)/Psoriasis Area and Severity Index (PASI) of disease severity of mild or moderate on the body (trunk and/or limbs).
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Have lesions involving 2-30% of the body (trunk and/or limbs). For subjects with scalp psoriasis included in the treatment area, the total treatment area on body and scalp must not exceed 30%.
Exclusion Criteria:
-
Use of topical anti psoriatic therapy within one week prior to the beginning of the study and willing to not use other psoriasis treatments for 4 weeks following completion of the treatment portion of the study.
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Received systemic biologic therapy to treat psoriasis within 12 weeks prior to the beginning of the study.
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Received systemic psoriasis therapy within 4 weeks prior to the beginning of the study.
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Received phototherapy (including laser) or photodynamic (light activated drug) therapy within 4 weeks prior to the beginning of the study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Soligenix
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HPN-PSR-01