Topical SGX302 for Mild-to-Moderate Psoriasis

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05442190
• Other study ID #: HPN-PSR-01
• Status: Recruiting
• Phase: Phase 2
• Start date: December 14, 2022
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Soligenix
• Contact: Christopher Pullion, DO
• Phone: 609-538-8200
• Email: cpullion[@]soligenix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate SGX302 (topical hypericin ointment) with visible light in an initial 18-week treatment course for improving lesions in patients with mild-to-moderate psoriasis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Hypericin
SGX302 is synthetic hypericin formulated as a 0.25% hypericin ointment.
• Placebo
Placebo ointment is identical to SGX302 ointment (color matched) but it does not contain hypericin.

Locations

Country	Name	City	State
United States	Therapeutics Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Soligenix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)).	18 weeks
Secondary	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.	18 weeks
Secondary	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.	18 weeks