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CompletedNCT05442190Updated Aug 13, 2026

Topical SGX302 for Mild-to-Moderate Psoriasis

A Phase 2 interventional study of Hypericin in Psoriasis, Plaque Psoriasis and Psoriasis Vulgaris, sponsored by Soligenix. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Soligenix · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis
  • Plaque Psoriasis
  • Psoriasis Vulgaris

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Keywords

  • Hypericin
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 15 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Soligenix is the lead sponsor of 11 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Cohort 1 - SGX302 Ointment (0.25 % 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 with a gradual escalation of light therapy up to 25 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks.

    Drug: Hypericin

  • Experimental
    Cohort 2 - SGX302 Ointment (0.25 % 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 with a faster escalation of light therapy up to 25 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks.

    Drug: Hypericin

  • Experimental
    Cohort 3 - SGX302 Gel (0.25 % Hypericin)

    SGX302 (0.25 % hypericin) gel will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm\^2 with a faster escalation of light therapy up to 40 J/cm\^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks.

    Drug: Hypericin

Interventions

  • DrugHypericin

    SGX302 is synthetic hypericin formulated as a 0.25% hypericin ointment or gel.

    Also known as: SGX302

06

What researchers measure

Primary outcomes

  1. Number of patients that achieve a 0 or 1 score using the 5-point Investigator's Global Assessment scale

    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

    Time frame: 18 weeks

Secondary outcomes

  1. Number of patients achieving a ≥75% improvement in Psoriasis Area and Severity Index

    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)).

    Time frame: 18 weeks

  2. Number of patients achieving a ≥90% improvement in Psoriasis Area and Severity Index

    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.

    Time frame: 18 weeks

  3. Number of patients achieving a 100% improvement in Psoriasis Area and Severity Index

    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.

    Time frame: 18 weeks

07

Study locations

1 site
  • Therapeutics Clinical Research
    San Diego, California 92123, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05442190
Lead sponsor
Soligenix
Responsible party
Sponsor
First posted
Jul 1, 2022
Start date
Dec 14, 2022
Primary completion
Oct 22, 2025
Completion
Nov 17, 2025
Last update
Aug 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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