A Phase 2 Study of PH-10 for the Treatment of Atopic Dermatitis
This study has been completed.
Sponsor:
Provectus Pharmaceuticals
Information provided by:
Provectus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00690807
First received: June 3, 2008
Last updated: September 24, 2009
Last verified: September 2009
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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 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Atopic Dermatitis |
Resource links provided by NLM:
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: | 30 |
| Study Start Date: | June 2008 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
Locations
| United States, Florida | |
| International Dermatology Research | |
| Miami, Florida, United States, 33144 | |
| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
Sponsors and Collaborators
Provectus Pharmaceuticals
Investigators
| Principal Investigator: | Alicia Barba, MD | International Dermatology Research |
More Information
No publications provided
| Responsible Party: | Eric Wachter, Vice President, Provectus Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00690807 History of Changes |
| Other Study ID Numbers: | PH-10-AD-21 |
| Study First Received: | June 3, 2008 |
| Last Updated: | September 24, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Provectus Pharmaceuticals:
|
eczema |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn |
Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013