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

NCT ID: NCT00690807

Last Updated: 2009-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-09-30

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

PH-10 treatment

Group Type: EXPERIMENTAL

PH-10

Intervention Type: DRUG

PH-10 will be applied daily for 28 days to skin areas affected by atopic dermatitis.

Interventions

PH-10

PH-10 will be applied daily for 28 days to skin areas affected by atopic dermatitis.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Provectus Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Provectus Pharmaceuticals, Inc.

Principal Investigators

Alicia Barba, MD

Role: PRINCIPAL_INVESTIGATOR

International Dermatology Research, Inc.

Locations

International Dermatology Research

Miami, Florida, United States

Mount Sinai School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

PH-10-AD-21

Identifier Type: -

Identifier Source: org_study_id