PH-10 for Atopic Dermatitis

Future Plans

  • A mechanism of action study is underway to assess the clinical and cellular response to PH-10's active investigational agent.
  • A total of 226 subjects have been treated with PH-10 in Phase 1 or Phase 2 clinical trials.

Phase 2 Clinical Trial

  • In December 2009, preliminary data for the Phase 2 study was released. Preliminary data from the first 18 subjects indicated that 94% of subjects had improvement in the Eczema Area Severity Index (EASI) during four weeks of treatment. The treatments were well tolerated and no significant safety issues were noted. The full clinical study report was submitted to FDA in May 2010.
  • The Phase 2 study was completed in September 2009. There were 27 subjects treated in the completed Phase 2 study.
  • In July 2009, patient enrollment for the Phase 2 study was completed.
  • In March 2009, patient enrollment began at a second clinical site, Mount Sinai School of Medicine in New York. The principal investigator at this center is Jason Emer, MD.
  • Patient enrollment began in June 2008 at International Dermatology Research in Miami. The principal investigator at this center is Alicia Barba, MD.
  • A Phase 2 study of PH-10 for the treatment of atopic dermatitis was initiated in June 2008. 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. Subjects will apply PH-10 daily for 28 days to skin areas affected by atopic dermatitis. Subjects will be assessed weekly during the treatment period and for 4 weeks following the treatment period.

    Primary Outcome Measures:

    • Treatment Success, 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 ]
    • Adverse experience, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality). [ Time Frame: 8 weeks ]

    Secondary Outcome Measures

    • Investigator's Global Assessment (IGA) score changes at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ]
    • Eczema Area Severity Index (EASI) score changes of individual atopic dermatitis signs at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ]
    • Pruritus Self-Assessment score changes of atopic dermatitis related itching/scratching at each visit from Day 1 pre-treatment. [ Time Frame: 8 weeks ]
    • Adverse change in clinical laboratory tests (CBC and CMP). [ Time Frame: 8 weeks ]
    • Adverse change in vital signs (BP, pulse, temperature). [ Time Frame: 8 weeks ]

Phase 1 Clinical Trial

  • In 2001-2002, a total of 24 subjects were treated in two Phase 1 studies of PH-10 for the treatment of actinic keratosis. The treatments were well tolerated and no significant safety issues were noted.

NEWSLETTER
Errors