PsoriasisPhase 2NCT05442190
Topical SGX302 for Mild-to-Moderate Psoriasis
A Phase 2 study testing Hypericin in people with Psoriasis and Plaque Psoriasis, run by Soligenix at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis, Plaque Psoriasis, Psoriasis Vulgaris
- What is being tested?
- Hypericin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2022to 17 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Therapeutics Clinical Research
San Diego, California, 92123
About this study
Official title: Phase 2 Study Evaluating SGX302 (Synthetic Hypericin) in the Treatment of 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-moderate psoriasis.
- Conditions
- Psoriasis, Plaque Psoriasis, Psoriasis Vulgaris
- Being tested
- Hypericin
- Keywords
- Hypericin
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypericinDrug
Also called SGX302
SGX302 is synthetic hypericin formulated as a 0.25% hypericin ointment or gel.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - SGX302 Ointment (0.25 % Hypericin) | Experimental | 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. Receives: Drug: Hypericin |
| Cohort 2 - SGX302 Ointment (0.25 % Hypericin) | Experimental | 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. Receives: Drug: Hypericin |
| Cohort 3 - SGX302 Gel (0.25 % Hypericin) | Experimental | 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. Receives: Drug: Hypericin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 weeks
Secondary outcomes (3)
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)).
Measured: 18 weeks
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.
Measured: 18 weeks
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.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start14 Dec 2022
- Primary completion22 Oct 2025
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a 2 part study. All protocol procedures, timing for schedule of events and assessments are identical for Parts A and B. In Part A, 10-15 patients will be assigned open-label SGX302 (ointment or gel). Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, approximately 32 patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to a placebo. Only Part A of the study was conducted.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soligenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442190
- Sponsor's protocol ID
- HPN-PSR-01
- Status last verified
- Aug 2026
- First submitted
- 28 Jun 2022
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study Evaluating SGX302 (Synthetic Hypericin) in the Treatment of Mild-to-Moderate Psoriasis
- ClinicalTrials.gov ID
- NCT05442190
- Acronym / sponsor ID
- HPN-PSR-01
- Conditions
- Psoriasis, Plaque Psoriasis, Psoriasis Vulgaris
- Keywords
- Hypericin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- SoligenixIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a 2 part study. All protocol procedures, timing for schedule of events and assessments are identical for Parts A and B. In Part A, 10-15 patients will be assigned open-label SGX302 (ointment or gel). Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, approximately 32 patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to a placebo. Only Part A of the study was conducted.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - SGX302 Ointment (0.25 % Hypericin) | Experimental | Drug: HypericinSGX302 (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. |
| Cohort 2 - SGX302 Ointment (0.25 % Hypericin) | Experimental | Drug: HypericinSGX302 (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. |
| Cohort 3 - SGX302 Gel (0.25 % Hypericin) | Experimental | Drug: HypericinSGX302 (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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypericinAlso: SGX302SGX302 is synthetic hypericin formulated as a 0.25% hypericin ointment or gel. | Drug | Cohort 1 - SGX302 Ointment (0.25 % Hypericin), Cohort 2 - SGX302 Ointment (0.25 % Hypericin), Cohort 3 - SGX302 Gel (0.25 % Hypericin) |
Primary outcome
Number of patients that achieve a 0 or 1 score using the 5-point Investigator's Global Assessment scale
Time frame: 18 weeks
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
3 secondary outcomes
Number of patients achieving a ≥75% improvement in Psoriasis Area and Severity Index
Time frame: 18 weeks
Number of patients achieving a ≥90% improvement in Psoriasis Area and Severity Index
Time frame: 18 weeks
Number of patients achieving a 100% improvement in Psoriasis Area and Severity Index
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypericin in people with Psoriasis and Plaque Psoriasis, run by Soligenix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that achieve a 0 or 1 score using the 5-point Investigator's Global Assessment scale (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.