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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Haymara Gonzalez | 305-225-0400 | info@intldermresearch.com |
| United States, Florida | |||||
| International Dermatology Research | Recruiting | ||||
| Miami, Florida, United States, 33144 | |||||
| Contact: Haymara Gonzalez 305-225-0400 | |||||
| Principal Investigator: Alicia Barba, MD | |||||
| Provectus Pharmaceuticals |
| 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 |
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