Topical SGX302 for Mild-to-Moderate Psoriasis

NCT05442190 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: HPN-PSR-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis; Plaque Psoriasis; Psoriasis Vulgaris

Keywords

Hypericin

Outcome Measures

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

  18 weeks

Secondary Outcomes (3)

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

  18 weeks

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

  18 weeks

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

  18 weeks

Study Arms (3)

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. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks.

Drug: Hypericin

Placebo (Ointment without Hypericin)

PLACEBO COMPARATOR

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.

Drug: Placebo

SGX302 Gel (0.25 % hypericin)

EXPERIMENTAL

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.

Drug: Hypericin

Interventions

Hypericin DRUG

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

Also known as: SGX302

SGX302 Gel (0.25 % hypericin); SGX302 Ointment (0.25 % Hypericin)

Placebo DRUG

Placebo ointment is identical to SGX302 ointment (color matched) but it does not contain hypericin.

Placebo (Ointment without Hypericin)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soligenix: lead

Study Sites (1)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

hypericin

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: December 14, 2022
• Primary Completion: October 22, 2025
• Study Completion: November 17, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)