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SGX302 (Ointment with 0.25 % Hypericin) for Plaque Psoriasis

Therapeutics Clinical Research, San Diego, CA
Plaque Psoriasis+1 More ConditionsHypericin - Drug
Eligibility
18 - 75
All Sexes

Study Summary

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

Eligible Conditions
  • Plaque Psoriasis
  • Psoriasis

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Plaque Psoriasis PF-07038124 0.06% ointment
1
Cohort 2
1
NBUVB phototherapy

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 18 weeks

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

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

2
Plaque Psoriasis PF-07038124 0.06% ointment
2
Cohort 2
2
NBUVB phototherapy

Side Effects for

Cycle 3 - SGX301
5%Application site pain
5%Pruritus
5%Respiratory, thoracic and mediastinal disorders
5%Injury, poisoning and procedural complications
4%Viral upper respiratory tract infection
4%Musculoskeletal and connective tissue disorders
3%Sinusitis
2%Application site paraesthesia
2%Dizziness
2%Nausea
2%Upper respiratory tract infection
2%Influenza
2%Fatigue
2%Headache
2%Neoplasms benign, malignant and unspecified (incl cysts and polyps)
1%Pneumonia
1%Erythema
1%Gallbladder obstruction
1%Cholecystitis
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT02448381) in the Cycle 3 - SGX301 ARM group. Side effects include: Application site pain with 5%, Pruritus with 5%, Respiratory, thoracic and mediastinal disorders with 5%, Injury, poisoning and procedural complications with 5%, Viral upper respiratory tract infection with 4%.

Trial Design

2 Treatment Groups

SGX302 (Ointment with 0.25 % Hypericin)
1 of 2
Placebo (Ointment without Hypericin)
1 of 2

Experimental Treatment

Non-Treatment Group

42 Total Participants · 2 Treatment Groups

Primary Treatment: SGX302 (Ointment with 0.25 % Hypericin) · Has Placebo Group · Phase 2

SGX302 (Ointment with 0.25 % Hypericin)
Drug
Experimental Group · 1 Intervention: Hypericin · Intervention Types: Drug
Placebo (Ointment without Hypericin)
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypericin
2022
Completed Phase 2
~10

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 18 weeks

Who is running the clinical trial?

SoligenixLead Sponsor
8 Previous Clinical Trials
763 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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