Topical SGX302 for Mild-to-Moderate Psoriasis

NCT ID: NCT05442190

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-14
• Study Completion Date: 2025-11-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Hypericin

Intervention Type: DRUG

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

Placebo (Ointment without Hypericin)

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

SGX302 Gel (0.25 % hypericin)

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 Type: EXPERIMENTAL

Hypericin

Intervention Type: DRUG

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

Interventions

Hypericin

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

SGX302

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soligenix

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Therapeutics Clinical Research

San Diego, California, United States

Countries

United States

Other Identifiers

HPN-PSR-01

Identifier Type: -

Identifier Source: org_study_id