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Photosensitizer

Hypericin for Psoriasis

Phase 2

Recruiting

Research Sponsored by Soligenix

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 weeks

Summary

This trialtests a topical ointment to improve psoriasis symptoms with light therapy over 18 weeks.

Who is the study for?

This trial is for people with mild-to-moderate psoriasis covering 2-30% of their body. Candidates must have had plaque psoriasis for at least six months and be able to apply topical treatment. They shouldn't have used anti-psoriatic therapies, systemic treatments, or phototherapy close to the study start date.

What is being tested?

The trial tests SGX302 (topical hypericin ointment) combined with visible light over an 18-week period to see if it improves skin lesions in patients with mild-to-moderate psoriasis.

What are the potential side effects?

Potential side effects are not specified here but generally could include skin irritation, redness, or sensitivity due to the active ingredient hypericin when exposed to light.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients that achieve a 0 or 1 score using the 5-point Investigator's Global Assessment scale

Secondary study objectives

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

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

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

Side effects data

From 2022 Phase 2 trial • 9 Patients • NCT05380635

11%

Chills

11%

Pruritis

11%

Urticaria

11%

Photosensitivity reaction

11%

Coronavirus infection

11%

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

HyBryte (0.25 % Hypericin)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SGX302 (Ointment with 0.25 % Hypericin)Experimental Treatment1 Intervention

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 II: Placebo (Ointment without Hypericin)Placebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypericin

Not yet FDA approved

Do I qualify?Apply below to find out