A Phase 2 Study of PH-10 for the Treatment of Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2 Efficacy and Safety Study of PH-10 Aqueous Hydrogel for the Treatment of Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: PH-10


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PH-10 treatment | Drug: PH-10<br>* PH-10 will be applied daily for 28 days to skin areas affected by atopic dermatitis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's Global Assessment (IGA) score changes 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 | 
| Pruritus Self-Assessment score changes of atopic dermatitis related itching/scratching at each visit from Day 1 pre-treatment. |  | 8 weeks | 
| Adverse change in clinical laboratory tests (CBC and CMP). |  | 8 weeks | 
| Adverse change in vital signs (BP, pulse, temperature). |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eczema