Hypericin for Psoriasis

Overseen By Michelle Villalta

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Soligenix

Must not be taking: Biologics, Systemic therapies

Disqualifiers: Recent phototherapy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 18 weeks

47 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with mild-to-moderate plaque psoriasis, a skin condition causing red, scaly patches. Researchers aim to determine if a topical treatment called SGX302 (also known as HyBryte or Synthetic Hypericin), used with visible light, can improve these skin lesions. Participants will apply either an ointment or gel with hypericin, or a placebo (a treatment with no active medicine), to their skin twice a week for 18 weeks. Those who have had plaque psoriasis for at least 6 months and have skin patches covering 2-30% of their body might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

Yes, you will need to stop using topical anti-psoriatic treatments at least one week before the study and avoid other psoriasis treatments for four weeks after the treatment ends. If you are on systemic psoriasis therapy or biologic therapy, you must stop them four and twelve weeks before the study, respectively.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that SGX302, a treatment using a synthetic version of hypericin, has a strong safety record. An earlier study on mild to moderate psoriasis found this treatment safe and easy for patients to manage, with improvements in skin observed without serious side effects.

Additionally, research on early-stage cutaneous T-cell lymphoma (CTCL), a similar condition, demonstrated that the treatment is both effective and safe. These findings are promising for its use in psoriasis, suggesting it might be a well-tolerated option.

The treatment involves applying an ointment or gel containing hypericin to the skin, followed by exposure to visible light. This method avoids the risks associated with more invasive treatments, such as infections or cancer. Overall, the evidence suggests that SGX302 could be a safe choice for those considering participation in a clinical trial for psoriasis. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for psoriasis, which often involve topical steroids, vitamin D analogs, or systemic medications, SGX302 uses hypericin, a plant-derived compound, as its active ingredient. Researchers are excited about these treatments because hypericin is activated by visible light, offering a unique mechanism that might reduce inflammation with fewer side effects. Additionally, SGX302 is applied as both an ointment and a gel, providing flexibility in treatment options. This novel approach could offer a safer and more convenient alternative for managing psoriasis.

What evidence suggests that SGX302 might be an effective treatment for psoriasis?

Research has shown that SGX302, which contains hypericin, may help treat skin conditions like psoriasis. Participants in this trial will receive either SGX302 Ointment or SGX302 Gel, both containing hypericin, or a placebo ointment without hypericin. In earlier studies on a different skin condition called CTCL, about 75% of patients responded positively to hypericin treatment after 18 weeks. Specifically, hypericin, when used with visible light, improved skin problems. These studies found the treatment to be safe and well-tolerated, which is encouraging for its use in psoriasis. Early results in psoriasis patients have also shown improvements, making SGX302 a promising option for those with mild-to-moderate psoriasis. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for people with mild-to-moderate psoriasis covering 2-30% of their body. Candidates must have had plaque psoriasis for at least six months and be able to apply topical treatment. They shouldn't have used anti-psoriatic therapies, systemic treatments, or phototherapy close to the study start date.

Inclusion Criteria

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%.

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).

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.

You have received treatment for psoriasis within the last 4 weeks prior to the study.

Received systemic biologic therapy to treat psoriasis within 12 weeks prior to the beginning of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SGX302 (topical hypericin ointment and gel) with visible light for 18 weeks to improve lesions in mild-to-moderate psoriasis

18 weeks

Twice a week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SGX302

Trial Overview The trial tests SGX302 (topical hypericin ointment) combined with visible light over an 18-week period to see if it improves skin lesions in patients with mild-to-moderate psoriasis.

How Is the Trial Designed?

Group I: SGX302 Ointment (0.25 % Hypericin) Experimental Treatment 1 Intervention

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.

Group II: SGX302 Gel (0.25 % hypericin) Experimental Treatment 1 Intervention

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.

Group III: Placebo (Ointment without Hypericin) Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Soligenix

Lead Sponsor

Trials

12

Recruited

900+

Published Research Related to This Trial

PS-519, a selective proteasome inhibitor, effectively reduces T cell activation and proliferation in response to bacterial superantigens, both in laboratory settings and in a psoriasis model involving human skin grafts.

The treatment with PS-519 not only inhibited T cell activation markers but also decreased the expression of molecules that facilitate T cell homing to the skin, suggesting its potential as a therapeutic option for managing psoriasis and other T cell-mediated disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proteasome inhibition reduces superantigen-mediated T cell activation and the severity of psoriasis in a SCID-hu model. Zollner, TM., Podda, M., Pien, C., et al.[2018]

In a study involving patients with mild to moderate psoriasis, genistein demonstrated significant clinical benefits, including reduced symptoms and no serious side effects, indicating its safety and tolerability as a treatment option.

In vitro experiments revealed that genistein effectively inhibits inflammatory pathways associated with psoriasis, such as IL-17A and TNF-α signaling, suggesting it could be a valuable addition to existing psoriasis therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of isoflavone genistein on psoriasis in in vivo and in vitro investigations. Bocheńska, K., Moskot, M., Smolińska-Fijołek, E., et al.[2021]

In psoriatic skin, the antimicrobial peptides psoriasin and koebnerisin are induced by Th17 cytokines, particularly IL-17A, which amplifies inflammation and contributes to the disease's pathology.

The vitamin D analog calcipotriol can effectively disrupt the inflammatory feedback loop by reducing the production of these peptides, suggesting a potential therapeutic strategy for managing psoriasis and similar inflammatory skin conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D analog calcipotriol suppresses the Th17 cytokine-induced proinflammatory S100 "alarmins" psoriasin (S100A7) and koebnerisin (S100A15) in psoriasis. Hegyi, Z., Zwicker, S., Bureik, D., et al.[2023]

In a 12-week randomized double-blind trial involving 45 patients, Psori Silk demonstrated significant efficacy in treating mild to moderate psoriasis, with 59% of patients achieving a 50% reduction in their psoriasis severity compared to only 22.7% in the vehicle group.

Psori Silk also improved quality of life, with 65.2% of patients experiencing a 33% improvement in their Dermatology Life Quality Index score, indicating it is a safe and effective alternative to long-term topical corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psori Silk in Mild to Moderate Psoriasis: A Randomized Phase I-II Trial Study. Pavlotsky, F., Babaev, M., Barzilai, A.[2023]

BTH, a synthetic derivative of a natural compound, effectively inhibits key inflammatory cytokines involved in psoriasis by downregulating the NF-κB signaling pathway in human skin cells, suggesting its potential as a treatment for this condition.

In vivo studies using two mouse models of psoriasis demonstrated that topical BTH application reduced skin inflammation and hyperplasia by impairing the phosphorylation of NF-κB and STAT3, confirming its therapeutic efficacy in managing psoriasis-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NF-κB and STAT3 inhibition as a therapeutic strategy in psoriasis: in vitro and in vivo effects of BTH. Andrés, RM., Montesinos, MC., Navalón, P., et al.[2022]

Citations

1. ir.soligenix.com ir.soligenix.com/2024-01-04-Soligenix-Announces-Top-line-Results-of-the-Phase-2a-Study-of-SGX302-Synthetic-Hypericin-in-Patients-with-Mild-to-Moderate-Psoriasis

Soligenix Announces Top-line Results of the Phase 2a Study ... In a published Phase 1/2 proof of concept clinical study using synthetic hypericin, efficacy was demonstrated in patients with CTCL (58.3% ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05442190?term=AREA%5BConditionSearch%5D(%22Psoriasis%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING)&rank=10

Topical SGX302 for Mild-to-Moderate Psoriasis 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 ...

3. dermatologytimes.com dermatologytimes.com/view/phase-2a-study-of-synthetic-hypericin-for-mild-to-moderate-psoriasis-yields-clinical-success

Phase 2a Study of Synthetic Hypericin for Mild to Moderate ... In the proof-of-concept phase, the treatment proved to be safe, effective, and well-tolerated, showcasing improvements in skin lesions among ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9301595/

Efficacy and Safety of Topical Hypericin Photodynamic ... Outcomes at these later time points (ILRR, 40% and 49% at wk 16 and 24) demonstrated clinical response kinetics that were comparable to other MF ...

5. ir.soligenix.com ir.soligenix.com/2025-04-14-Positive-Outcome-in-75-of-CTCL-Patients-Treated-with-HyBryte-TM-for-18-Weeks

Positive Outcome in 75% of CTCL Patients Treated with ... SGX302 Plaque Psoriasis Treatment for Mild to Moderate Psoriasis ... HyBryte™ clinical studies, has been exciting to see," noted Dr. Kim ...

6. ir.soligenix.com ir.soligenix.com/2025-10-07-Soligenix-Achieves-Important-Safety-Milestone-in-its-Confirmatory-Phase-3-Clinical-Trial-of-HyBryte-TM-for-the-Treatment-of-Cutaneous-T-Cell-Lymphoma

News Releases "In the Phase 3 FLASH study, HyBryte™ was shown to be efficacious in early-stage CTCL with a promising safety profile," stated Ellen Kim, MD, ...

7. prnewswire.com prnewswire.com/news-releases/soligenix-achieves-important-safety-milestone-in-its-confirmatory-phase-3-clinical-trial-of-hybryte-for-the-treatment-of-cutaneous-t-cell-lymphoma-302576600.html

Soligenix Achieves Important Safety Milestone in its ... In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin ...