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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PH-10
Sponsored by
Provectus Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring eczema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • International Dermatology Research
  • Mount Sinai School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

PH-10 treatment

Outcomes

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.
Adverse experience, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).

Secondary Outcome Measures

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

Full Information

First Posted
June 3, 2008
Last Updated
September 24, 2009
Sponsor
Provectus Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00690807
Brief Title
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

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Provectus Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
PH-10 treatment
Intervention Type
Drug
Intervention Name(s)
PH-10
Intervention Description
PH-10 will be applied daily for 28 days to skin areas affected by atopic dermatitis.
Primary Outcome Measure Information:
Title
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
Title
Adverse experience, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Investigator's Global Assessment (IGA) score changes at each visit from Day 1 pre-treatment.
Time Frame
8 weeks
Title
Eczema Area Severity Index (EASI) score changes of individual atopic dermatitis signs at each visit from Day 1 pre-treatment.
Time Frame
8 weeks
Title
Pruritus Self-Assessment score changes of atopic dermatitis related itching/scratching at each visit from Day 1 pre-treatment.
Time Frame
8 weeks
Title
Adverse change in clinical laboratory tests (CBC and CMP).
Time Frame
8 weeks
Title
Adverse change in vital signs (BP, pulse, temperature).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia Barba, MD
Organizational Affiliation
International Dermatology Research, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Dermatology Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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