Topical SGX302 for Mild-to-Moderate Psoriasis
- Conditions
- Plaque PsoriasisPsoriasisPsoriasis Vulgaris
- Interventions
- Drug: Placebo
- Registration Number
- NCT05442190
- Lead Sponsor
- Soligenix
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 47
- 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%.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SGX302 Ointment (0.25 % Hypericin) 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. Placebo (Ointment without Hypericin) Placebo 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) Hypericin 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Therapeutics Clinical Research
🇺🇸San Diego, California, United States