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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

Awards & highlights

Study Summary

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

Eligible Conditions

Plaque Psoriasis
Psoriasis

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Find a Location

Who is running the clinical trial?

SoligenixLead Sponsor

9 Previous Clinical Trials

773 Total Patients Enrolled

Media Library

SGX302 (Photosensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05442190 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction on participating in this trial?

"This research is currently seeking volunteers aged 18 or over, yet under 75 years old."

Answered by AI

What is the scope of individuals participating in this trial?

"Affirmative. Clinicaltrials.gov shows that this trial, which was first published on December 14th 2022 is presently looking for individuals to participate in it. 42 participants must be found from a single site."

Answered by AI

What risks, if any, are associated with the application of SGX302 (Ointment with 0.25 % Hypericin)?

"As this is a Phase 2 trial, there is some evidence in favor of SGX302's (Ointment with 0.25 % Hypericin) safety but little to none concerning its efficacy; consequently, it earned an overall score of two on our scale from one to three."

Answered by AI

Do any openings remain for participants in this experiment?

"Yes, the information on clinicaltrials.gov shows that this research is actively enrolling participants. This trial was initially posted on December 14th 2022 and subsequently updated on December 15th 2022. As of now, 42 willing volunteers are required from a single medical centre for it to be successful."

Answered by AI

Does my profile satisfy the prerequisites for this trial?

"This clinical study is in search of 42 people with a minimum six-month history of psoriasis and aged from 18 to 75. Said participants must meet the following requirements: possess a mild or moderate degree of skin inflammation, present lesions covering 2% to 30% body area (including scalp), and be suitable for topical applications that can provide full coverage."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Topical SGX302 for Mild-to-Moderate Psoriasis

2022. "Topical SGX302 for Mild-to-Moderate Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05442190.

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