Randomized Study of PH-10 for Psoriasis

Psoriasis Clinical Trial

Official title:

A Phase 2 Dose-Randomized, Vehicle-Controlled Study of PH-10-Aqueous Hydrogel for the Treatment of Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247818
• Other study ID #: PH-10-PS-23
• Status: Completed
• Phase: Phase 2
• First received: November 23, 2010
• Last updated: September 27, 2012
• Start date: December 2010
• Est. completion date: March 2012

Study information

• Verified date: September 2012
• Source: Provectus Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 multicenter phase 2 study of subjects randomized sequentially by center to one of four treatment cohorts will assess efficacy and safety of topical PH-10 applied once daily to areas of mild to moderate plaque psoriasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: March 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

• Female subjects of childbearing potential who are pregnant, attempting to conceive, not using effective contraception, or who are nursing an infant.

• Subjects who have received psoralen plus ultraviolet A (PUVA) therapy or systemic antipsoriatic therapy (immunosuppressants, cytostatics, corticosteroids) within 28 days of study initiation (two weeks for methotrexate).

• Subjects who have received ultraviolet B (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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• PH-10 (0.002% Rose Bengal)
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
• PH-10 (0.005% Rose Bengal)
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
• PH-10 (0.01% Rose Bengal)
PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
• Vehicle
PH-10 vehicle will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.

Locations

Country	Name	City	State
United States	International Dermatology Research	Miami	Florida
United States	Mount Sinai School of Medicine	New York	New York
United States	Dermatology Specialists, Inc.	Oceanside	California
United States	Wake Research Associates	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Provectus Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		28 days	No
Primary	The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).		8 weeks	Yes
Secondary	Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment.		8 weeks	No
Secondary	Plaque Response score changes at each visit from Day 1 pre-treatment.		8 weeks	No
Secondary	Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment.		8 weeks	No