Back to resultsAn Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PH-10 (0.001% Rose Bengal)
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Men or women, age 18 or older.
- Presence of mild to moderate plaque psoriasis on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous areas).
- Fitzpatrick skin type I-VI.
- Written informed consent by the subject or legal guardian.
Exclusion Criteria:
- Women of childbearing potential who are pregnant, attempting to conceive, not using effective contraception, or who are nursing an infant.
- Subjects who have received PUVA or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (two weeks for methotrexate).
- Subjects who have received UVB light therapy within 14 days of study initiation.
- Subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin or Vitamin D analogs) to the study plaque areas within 14 days of study initiation.
- Subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of study initiation.
- Subjects who have received any approved or investigational biologic drug therapy for psoriasis within 90 days or 5 half-lives of study initiation.
- Subjects who have participated in a clinical research study within 28 days of study initiation.
- Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
- Subjects with clinical conditions that, in the opinion of the Investigator may pose a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
Sites / Locations
- International Dermatology Research
- Mount Sinai School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PH-10 Treatment
Arm Description
Outcomes
Primary Outcome Measures
The primary efficacy endpoint is "Treatment Success," a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale.
The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).
Secondary Outcome Measures
Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment.
Plaque Response score changes at each visit from Day 1 pre-treatment.
Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00941278
Brief Title
An Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Provectus Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
PH-10 is an aqueous hydrogel formulation of rose bengal disodium (RB) for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. This phase 2 efficacy and safety study will assess topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PH-10 Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PH-10 (0.001% Rose Bengal)
Intervention Description
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
Primary Outcome Measure Information:
Title
The primary efficacy endpoint is "Treatment Success," a static endpoint assessed at Day 29 after initial PH-10 treatment and defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale.
Time Frame
28 days
Title
The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment.
Time Frame
8 weeks
Title
Plaque Response score changes at each visit from Day 1 pre-treatment.
Time Frame
8 weeks
Title
Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men or women, age 18 or older.
Presence of mild to moderate plaque psoriasis on the trunk or extremities (excluding palms, soles, scalp, and facial or intertriginous areas).
Fitzpatrick skin type I-VI.
Written informed consent by the subject or legal guardian.
Exclusion Criteria:
Women of childbearing potential who are pregnant, attempting to conceive, not using effective contraception, or who are nursing an infant.
Subjects who have received PUVA or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (two weeks for methotrexate).
Subjects who have received UVB light therapy within 14 days of study initiation.
Subjects who have received topical antipsoriatic therapy (including corticosteroids, tar, anthralin or Vitamin D analogs) to the study plaque areas within 14 days of study initiation.
Subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of study initiation.
Subjects who have received any approved or investigational biologic drug therapy for psoriasis within 90 days or 5 half-lives of study initiation.
Subjects who have participated in a clinical research study within 28 days of study initiation.
Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
Subjects with clinical conditions that, in the opinion of the Investigator may pose a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Wachter, PhD
Organizational Affiliation
Provectus Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
International Dermatology Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Plaque Psoriasis
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