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

Trial Summary

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.

How is the drug SGX302 (HyBryte, Synthetic Hypericin) unique for treating psoriasis?

SGX302 (HyBryte, Synthetic Hypericin) is unique because it uses hypericin, a compound derived from St. John's Wort, which is known for its potential anti-inflammatory and antiviral properties. This treatment may offer a novel approach by targeting different pathways involved in psoriasis compared to traditional therapies. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Impact of isoflavone genistein on psoriasis in in vivo and in vitro investigations. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

NF-κB and STAT3 inhibition as a therapeutic strategy in psoriasis: in vitro and in vivo effects of BTH. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Vitamin D analog calcipotriol suppresses the Th17 cytokine-induced proinflammatory S100 "alarmins" psoriasin (S100A7) and koebnerisin (S100A15) in psoriasis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Proteasome inhibition reduces superantigen-mediated T cell activation and the severity of psoriasis in a SCID-hu model. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Psori Silk in Mild to Moderate Psoriasis: A Randomized Phase I-II Trial Study. [2023]