Hypericin for Psoriasis
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Soligenix
Must not be taking: Biologics, Systemic therapies
Disqualifiers: Recent phototherapy, others
Prior Safety Data
Trial Summary
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.
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.
12345Eligibility 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.
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Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: SGX302 Ointment (0.25 % Hypericin)Experimental Treatment1 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 Treatment1 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 Group1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Therapeutics Clinical ResearchSan Diego, CA
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Who Is Running the Clinical Trial?
SoligenixLead Sponsor
References
Impact of isoflavone genistein on psoriasis in in vivo and in vitro investigations. [2021]Genistein is applied worldwide as an alternative medicament for psoriasis (Ps) because of its anti-inflammatory activity and perceived beneficial impact on the skin. Hereby, we report our in vivo and in vitro investigations to supplement scientific research in this area. The reduction of clinical and biochemical scores in mild to moderate Ps patients taking genistein, its safety, good tolerability with no serious adverse events or discontinuations of treatment, no dose-limiting toxicities, negligible changes in pharmacodynamic parameters and remarkable serum interleukin level alterations were documented in this study. A certain regression of the Ps phenotype was visible, based on photo-documented Ps lesion evaluation. Through in vitro experiments, we found that genistein reduced IL-17A and TNF-α induced MAPK, NF-κB, and PI3K activation in normal human epidermal keratinocytes. Moreover, at the mRNA level of genes associated with the early inflammatory response characteristic for Ps (CAMP, CCL20, DEFB4A, PIK3CA, S100A7, and S100A9) and key cellular signalling (MTORC1 and TFEB), we showed that this isoflavone attenuated the increased response of IL-17A- and TNF-α-related pathways. This allows us to conclude that genistein is a good candidate for Ps treatment, being attractive for co-pharmacotherapy with other drugs.
NF-κB and STAT3 inhibition as a therapeutic strategy in psoriasis: in vitro and in vivo effects of BTH. [2022]Benzo[b]thiophen-2-yl-3-bromo-5-hydroxy-5H-furan-2-one (BTH) is a simple and interesting synthetic derivative of petrosaspongiolide M, a natural compound isolated from a sea sponge with demonstrated potent anti-inflammatory activity through inhibition of the NF-κB signaling pathway. In the present study, we report the in vitro and in vivo pharmacological effect of BTH on some parameters related to the innate and adaptive response in the pathogenesis of psoriasis. BTH inhibited the release of some of the key psoriatic cytokines such as tumor necrosis factor α, IL-8, IL-6, and CCL27 through the downregulation of NF-κB in normal human keratinocytes. Moreover, it impaired signal transducers and activators of transcription 3 (STAT3) phosphorylation and translocation to the nucleus, which resulted in decreased keratinocyte proliferation. These results were confirmed in vivo in two murine models of psoriasis: the epidermal hyperplasia induced by 12-O-tetradecanoylphorbol-13-acetate and the imiquimod-induced skin inflammation model. In both cases, topical administration of BTH prevented skin infiltration and hyperplasia through suppression of NF-κB and STAT3 phosphorylation. Our results confirm the pivotal role of both transcriptional factors in skin inflammation, as occurs in psoriasis, and highlight the potential of small molecules as therapeutic agents for the treatment of this skin disease, with BTH being a potential candidate for future drug research.
Vitamin D analog calcipotriol suppresses the Th17 cytokine-induced proinflammatory S100 "alarmins" psoriasin (S100A7) and koebnerisin (S100A15) in psoriasis. [2023]The antimicrobial peptides (AMP) psoriasin (S100A7) and koebnerisin (S100A15) are differently induced in psoriatic skin. They act synergistically as chemoattractants and "alarmins" to amplify inflammation in psoriasis. Th17 cytokines are key players in psoriasis pathogenesis and vitamin D analogs feature anti-psoriatic effects; both of these activities could be mediated through epidermal AMP regulation. We show that supernatants of cultured psoriatic T cells induce and release psoriasin and koebnerisin from keratinocytes and the Th17 cytokines IL-17A, tumor necrosis factor-α, and IL-22 differently regulate psoriasin and koebnerisin reflecting their distinct expression pattern in normal and psoriatic skin. IL-17A is the principal inducer of both S100 and their expression is further amplified by cooperating Th17 cytokines in the micromilieu of psoriatic skin. Increased extracellular psoriasin and koebnerisin also synergize as "alarmins" to prime epidermal keratinocytes for production of immunotropic cytokines that further amplify the inflammatory response. Treatment of psoriatic plaques with the vitamin D analog calcipotriol interferes with the S100-mediated positive feedback loop by suppressing the increased production of psoriasin and koebnerisin in psoriatic skin and their Th17-mediated regulation in epidermal keratinocytes. Thus, targeting the S100-amplification loop could be a beneficial anti-inflammatory approach in psoriasis and other inflammatory skin diseases.
Proteasome inhibition reduces superantigen-mediated T cell activation and the severity of psoriasis in a SCID-hu model. [2018]There is increasing evidence that bacterial superantigens contribute to inflammation and T cell responses in psoriasis. Psoriatic inflammation entails a complex series of inductive and effector processes that require the regulated expression of various proinflammatory genes, many of which require NF-kappa B for maximal trans-activation. PS-519 is a potent and selective proteasome inhibitor based upon the naturally occurring compound lactacystin, which inhibits NF-kappa B activation by blocking the degradation of its inhibitory protein I kappa B. We report that proteasome inhibition by PS-519 reduces superantigen-mediated T cell-activation in vitro and in vivo. Proliferation was inhibited along with the expression of very early (CD69), early (CD25), and late T cell (HLA-DR) activation molecules. Moreover, expression of E-selectin ligands relevant to dermal T cell homing was reduced, as was E-selectin binding in vitro. Finally, PS-519 proved to be therapeutically effective in a SCID-hu xenogeneic psoriasis transplantation model. We conclude that inhibition of the proteasome, e.g., by PS-519, is a promising means to treat T cell-mediated disorders such as psoriasis.
Psori Silk in Mild to Moderate Psoriasis: A Randomized Phase I-II Trial Study. [2023]In patients with mild to moderate psoriasis, topical corticosteroids are usually the first-line of treatment; however, they are not suitable for long-term use. The purpose of this study was to assess the efficacy and safety of a multi-fruit-and-vegetable compound, Psori Silk, in the treatment of patients with psoriasis. This was a randomized double-blind trial comprising 12 weeks of treatment with Psori Silk versus a vehicle, and a 4-week follow-up. The primary endpoint was 50% reduction in the modified Psoriasis Area and Severity Index (MPASI 50) score at week 12, while the secondary endpoint was quality of life assessment using the Dermatology Life Quality Index (DLQI). The Psori Silk group consisted of 23 patients with 34 lesions to be treated versus 22 patients in the vehicle group with 36 lesions. The MPASI 50 score was observed in 59% patients in the active group versus 22.7% patients in the vehicle group (P < 0.001). A mean 33% DLQI improvement was observed in 65.2% patients in the active group versus 27.2% patients in the vehicle group (P < 0.001). Mild and temporary discomfort at the site of application was reported in 39% patients in the active group versus 23% patients in the vehicle group. Psori silk appears to be an effective and safe treatment option for mild to moderate plaque psoriasis.