Atopic Dermatitis
Conditions
Keywords
eczema
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 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.
Interventions
DRUGPH-10
PH-10 will be applied daily for 28 days to skin areas affected by atopic dermatitis.
Sponsors
Provectus Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 28 days |
| Adverse experience, including pain and dermatologic/skin toxicity (incidence, severity, frequency, duration and causality). | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pruritus Self-Assessment score changes of atopic dermatitis related itching/scratching at each visit from Day 1 pre-treatment. | 8 weeks |
| Eczema Area Severity Index (EASI) score changes of individual atopic dermatitis signs at each visit from Day 1 pre-treatment. | 8 weeks |
| Adverse change in vital signs (BP, pulse, temperature). | 8 weeks |
| Adverse change in clinical laboratory tests (CBC and CMP). | 8 weeks |
| Investigator's Global Assessment (IGA) score changes at each visit from Day 1 pre-treatment. | 8 weeks |
Countries
United States
Outcome results
None listed