Topical SGX302 for Mild-to-Moderate Psoriasis
Phase 2 Study Evaluating SGX302 (Synthetic Hypericin) in the Treatment of Mild-to-Moderate Psoriasis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92123
- Therapeutics Clinical Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cohort 1 - SGX302 Ointment (0.25 % Hypericin)
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 with a gradual escalation of light therapy up to 25 J/cm^2.
Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks.
|
SGX302 is synthetic hypericin formulated as a 0.25% hypericin ointment or gel.
Other Names:
|
|
Experimental: Cohort 2 - SGX302 Ointment (0.25 % Hypericin)
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 with a faster escalation of light therapy up to 25 J/cm^2.
Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks.
|
SGX302 is synthetic hypericin formulated as a 0.25% hypericin ointment or gel.
Other Names:
|
|
Experimental: Cohort 3 - SGX302 Gel (0.25 % Hypericin)
SGX302 (0.25 % hypericin) gel will be applied to lesions and treated with visible light 24±6 hours later starting at 5 J/cm^2 with a faster escalation of light therapy up to 40 J/cm^2.
Drug application/light session will be done twice a week (at least 2 calendar days apart) for 18 weeks.
|
SGX302 is synthetic hypericin formulated as a 0.25% hypericin ointment or gel.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)). |
18 weeks
|
|
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. |
18 weeks
|
|
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. |
18 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases, Papulosquamous
- Skin Diseases
- Skin and Connective Tissue Diseases
- Psoriasis
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antiviral Agents
- Psychotropic Drugs
- Antidepressive Agents
- hypericin
Other Study ID Numbers
- HPN-PSR-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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