A Phase 2 Study of PH-10 for the Treatment of Atopic Dermatitis

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: PH-10

• Registration Number: NCT00690807
• Lead Sponsor: Provectus Pharmaceuticals

Brief Summary

PH-10 is a formulation of rose bengal disodium (RB) for topical administration to the skin. PH-10 is capable of undergoing photochemical reactions when activated by ambient light. This phase 2 study will assess whether topical PH-10 applied once daily to mild, moderate or severe areas of atopic dermatitis (including atopic eczema) may ameliorate inflammation of the skin when activated by ambient light.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-05
• Primary Completion: 2009-08
• Status Verified: 2009-09
• Study Completion: 2009-09
• Last Update Submitted: 2009-09-24
• Last Update Posted: 2009-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Men or women, age 18 or older.
• Mild, moderate or severe atopic dermatitis.
• Presence of atopic dermatitis areas outside the head and face with a baseline Investigator Global Assessment (IGA) of 2 (mild disease), 3 (moderate) or 4 (severe disease) at screening.
• Written informed consent by the subject or legal guardian.

Exclusion Criteria

• Women who are pregnant, attempting to conceive, or nursing an infant.
• Subjects who have received phototherapy (UVB, PUVA) or systemic therapy (immunosuppressants, cytostatics, corticosteroids) within 4 weeks.
• Subjects who have received systemic antibiotics within 2 weeks.
• Subjects who have received topical therapy (tar, corticosteroids) within 7 days.
• Subjects who have received investigational drugs in a clinical research study within 4 weeks.
• Subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of initiation of study treatment.
• Subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum.
• Subjects with clinical conditions that 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	PH-10	PH-10 treatment

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is "Treatment Success," a static endpoint defined as a score of 0 to 1 at Day 28 (at the end of the study treatment period) by the Investigator's Global Assessment (IGA) scoring system for atopic dermatitis status.	28 days
Adverse experience, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).	8 weeks

Secondary Outcome Measures

Name	Time	Method
Investigator's Global Assessment (IGA) score changes at each visit from Day 1 pre-treatment.	8 weeks
Eczema Area Severity Index (EASI) score changes of individual atopic dermatitis signs at each visit from Day 1 pre-treatment.	8 weeks
Pruritus Self-Assessment score changes of atopic dermatitis related itching/scratching at each visit from Day 1 pre-treatment.	8 weeks
Adverse change in clinical laboratory tests (CBC and CMP).	8 weeks
Adverse change in vital signs (BP, pulse, temperature).	8 weeks

Trial Locations

Locations (2)

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

International Dermatology Research; 🇺🇸 Miami, Florida, United States