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

This study is currently recruiting participants.
Verified by Provectus Pharmaceuticals, July 2008

Sponsored by: 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

MedlinePlus related topics:   Eczema   

U.S. FDA Resources

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

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:   20
Study Start Date:   June 2008
Estimated Study Completion Date:   March 2009
Estimated Primary Completion Date:   December 2008 (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

Contacts
Contact: Haymara Gonzalez     305-225-0400     info@intldermresearch.com    

Locations
United States, Florida
International Dermatology Research     Recruiting
      Miami, Florida, United States, 33144
      Contact: Haymara Gonzalez     305-225-0400        
      Principal Investigator: Alicia Barba, MD            

Sponsors and Collaborators
Provectus Pharmaceuticals

Investigators
Principal Investigator:     Alicia Barba, MD     International Dermatology Research    
  More Information


Responsible Party:   Provectus Pharmaceuticals, Inc. ( Eric Wachter, Vice President )
Study ID Numbers:   PH-10-AD-21
First Received:   June 3, 2008
Last Updated:   July 9, 2008
ClinicalTrials.gov Identifier:   NCT00690807
Health Authority:   United States: Food and Drug Administration

Keywords provided by Provectus Pharmaceuticals:
eczema  

Study placed in the following topic categories:
Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Eczema
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on November 30, 2008




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