Topical treatment for mild-to-moderate psoriasis using SGX302
Phase 2 Study Evaluating SGX302 (Synthetic Hypericin) in the Treatment of Mild-to-Moderate Psoriasis
This study is testing a new ointment and light therapy to see if it helps people with mild-to-moderate psoriasis feel better and improve their skin.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 47 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Soligenix Industry-sponsored |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT05442190 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of SGX302, a topical ointment and gel containing hypericin, combined with visible light therapy, over an 18-week period for patients with mild-to-moderate psoriasis. Participants will apply the treatment to affected areas on their body, specifically targeting lesions that cover 2-30% of their trunk and/or limbs. The study aims to assess improvements in psoriasis severity as measured by established clinical scales. A placebo group will also be included to compare the treatment's efficacy.
Who should consider this trial
Good fit: Ideal candidates are individuals with a clinical diagnosis of plaque psoriasis lasting at least six months, with mild to moderate severity affecting 2-30% of their body.
Not a fit: Patients who have recently used other topical or systemic psoriasis treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from mild-to-moderate psoriasis.
How similar studies have performed: While this approach is novel, similar studies using topical treatments for psoriasis have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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. * 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.
Where this trial is running
San Diego, California
- Therapeutics Clinical Research — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Christopher Pullion, DO
- Email: cpullion@soligenix.com
- Phone: 609-538-8200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.