Clinical trial NCT00690807: A Phase 2 Study of PH-10 for the Treatment of Atopic Dermatitis
Official title: A Phase 2 Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: eczema
Lead sponsor: Provectus Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
timeFrame: 28 days
measure: Adverse experience, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).
timeFrame: 8 weeks
Secondary outcomes:
measure: Investigator's Global Assessment (IGA) score changes at each visit from Day 1 pre-treatment.
timeFrame: 8 weeks
measure: Eczema Area Severity Index (EASI) score changes of individual atopic dermatitis signs at each visit from Day 1 pre-treatment.
timeFrame: 8 weeks
measure: Pruritus Self-Assessment score changes of atopic dermatitis related itching/scratching at each visit from Day 1 pre-treatment.
timeFrame: 8 weeks
measure: Adverse change in clinical laboratory tests (CBC and CMP).
timeFrame: 8 weeks
measure: Adverse change in vital signs (BP, pulse, temperature).
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: International Dermatology Research
state: Florida
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
Study officials:
affiliation: International Dermatology Research, Inc.
name: Alicia Barba, MD
role: PRINCIPAL_INVESTIGATOR
References: