Status:
COMPLETED
A Phase 2 Study of PH-10 for the Treatment of Atopic Dermatitis
Lead Sponsor:
Provectus Pharmaceuticals
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00690807
Start Date
June 1 2008
End Date
September 1 2009
Last Update
September 28 2009
Active Locations (2)
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1
International Dermatology Research
Miami, Florida, United States, 33144
2
Mount Sinai School of Medicine
New York, New York, United States, 10029