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

Sponsor:	Provectus Pharmaceuticals
Information provided by:	Provectus Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00690807

Purpose

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.

Condition	Intervention	Phase
Atopic Dermatitis	Drug: PH-10	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Atopic Dermatitis

Resource links provided by NLM:

MedlinePlus related topics: Eczema

U.S. FDA Resources

Further study details as provided by Provectus Pharmaceuticals:

Primary Outcome Measures:

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. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Adverse experience, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Investigator's Global Assessment (IGA) score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Eczema Area Severity Index (EASI) score changes of individual atopic dermatitis signs at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Pruritus Self-Assessment score changes of atopic dermatitis related itching/scratching at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Adverse change in clinical laboratory tests (CBC and CMP). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Adverse change in vital signs (BP, pulse, temperature). [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	June 2008
Study Completion Date:	September 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental PH-10 treatment	Drug: PH-10 PH-10 will be applied daily for 28 days to skin areas affected by atopic dermatitis.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690807

Locations

United States, Florida
International Dermatology Research
Miami, Florida, United States, 33144
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029

Sponsors and Collaborators

Provectus Pharmaceuticals

Investigators

Principal Investigator:

Alicia Barba, MD

International Dermatology Research

More Information

No publications provided

Responsible Party:	Provectus Pharmaceuticals, Inc. ( Eric Wachter, Vice President )
Study ID Numbers:	PH-10-AD-21
Study First Received:	June 3, 2008
Last Updated:	September 24, 2009
ClinicalTrials.gov Identifier:	NCT00690807 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Provectus Pharmaceuticals:

eczema

Additional relevant MeSH terms:

Hypersensitivity
Dermatitis, Atopic
Immune System Diseases
Genetic Diseases, Inborn
Skin Diseases

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

ClinicalTrials.gov processed this record on November 25, 2009