An Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Plaque Psoriasis

NCT00941278 | Completed Phase 2

• 1 other identifier: PH-10-PS-22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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

• The primary safety endpoint is incidence of adverse experiences, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).

  8 weeks

Secondary Outcomes (3)

• Psoriasis Severity Index (PSI) score changes at each visit from Day 1 pre-treatment.

  8 weeks

• Plaque Response score changes at each visit from Day 1 pre-treatment.

  8 weeks

• Pruritus Self-Assessment score changes at each visit from Day 1 pre-treatment.

  8 weeks

Study Arms (1)

PH-10 Treatment

EXPERIMENTAL

Drug: PH-10 (0.001% Rose Bengal)

Interventions

PH-10 (0.001% Rose Bengal) DRUG

PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.

PH-10 Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Provectus Pharmaceuticals: lead

Study Sites (2)

International Dermatology Research

Miami, Florida, 33144, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Rose Bengal

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Eric Wachter, PhD

  Provectus Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 17, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2010
• Last Updated: July 7, 2010

Record last verified: 2010-07

Locations

US (2)