Plaque Psoriasis, Psoriasis, Psoriasis Vulgaris
Conditions
Keywords
Hypericin
Brief summary
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.
Interventions
DRUGHypericin
SGX302 is synthetic hypericin formulated as a 0.25% hypericin ointment or gel.
Sponsors
Soligenix
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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. Only Part A of the study was conducted.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. * 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). * 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. * Received systemic biologic therapy to treat psoriasis within 12 weeks prior to the beginning of the study. * Received systemic psoriasis therapy within 4 weeks prior to the beginning of the study. * Received phototherapy (including laser) or photodynamic (light activated drug) therapy within 4 weeks prior to the beginning of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed