NCT00690807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 28, 2009

Status Verified

September 1, 2009

Enrollment Period

1.2 years

First QC Date

June 3, 2008

Last Update Submit

September 24, 2009

Conditions

Atopic Dermatitis

Keywords

eczema

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

Study Arms (1)

1

EXPERIMENTAL

PH-10 treatment

Drug: PH-10

Interventions

PH-10DRUG

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Dermatitis, AtopicEczema

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Alicia Barba, MD

    International Dermatology Research, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 5, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2009

Study Completion

September 1, 2009

Last Updated

September 28, 2009

Record last verified: 2009-09

Locations

US(2)