| June 3, 2008 |
| September 24, 2009 |
| June 2008 |
| August 2009 (final data collection date for primary outcome 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. [ 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 ]
|
| Same as current |
| Complete list of historical versions of study NCT00690807 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Same as current |
| |
| A Phase 2 Study of PH-10 for the Treatment of Atopic Dermatitis |
| A Phase 2 Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Atopic Dermatitis |
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. |
| |
| Phase II |
| Interventional |
| Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Atopic Dermatitis |
| Drug: PH-10 |
| Experimental: PH-10 treatment |
| |
| |
| Completed |
| 30 |
| September 2009 |
| August 2009 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00690807 |
| Eric Wachter, Vice President, Provectus Pharmaceuticals, Inc. |
| PH-10-AD-21 |
| Provectus Pharmaceuticals |
|
| Principal Investigator: |
Alicia Barba, MD |
International Dermatology Research |
|
|
| Provectus Pharmaceuticals |
| September 2009 |