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Completed

NCT Number: NCT05442190

Topical SGX302 for 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.

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Key information

Conditions

Psoriasis Plaque Psoriasis Psoriasis Vulgaris Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypericin

Drug

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

Other names: SGX302

Placebo

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 18 weeks

    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)).

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

    Time frame: 18 weeks

    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.

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

    Time frame: 18 weeks

    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.

Sponsors and collaborators

Lead sponsor

Soligenix

Industry

Registry information

Official study title

Phase 2 Study Evaluating SGX302 (Synthetic Hypericin) in the Treatment of Mild-to-Moderate Psoriasis

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2022
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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