An Evaluation of PDI-320 in Comparison to Its Monads in Adults With Rosacea

Study Overview
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Brief Summary
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This 4-arm Phase 2 vehicle-controlled study is designed to assess the safety and efficacy of PDI-320, and the individual components, in adult subjects with rosacea.

Official Title
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A Multicenter Randomized Evaluator-Blinded Vehicle-Controlled Parallel Group Evaluation of Twice Daily PDI-320 in Comparison to Its Monads in Adults With Rosacea

Conditions
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Rosacea

Intervention / Treatment
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* Drug: PDI-320
* Drug: PDI-320 Monad #1
* Drug: PDI-320 Monad #2
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has moderate to severe papulopustular rosacea and at least mild erythema and mild telangiectasia. Subject is willing and able to apply the test article(s) as directed, comply with study instructions and commit to all follow-up visits for the duration of the study. If subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study. Exclusion Criteria: Subject is pregnant, lactating or is planning to become pregnant during the study. Subject has any other active dermatological condition on the face that may interfere with the conduct of the study. Subject has used systemic immunosuppressants within 30 days prior to study start. Subject has used systemic retinoids within 6 months prior to study start. Subject has used any topical rosacea therapy within 14 days prior to study start. Subject has had laser or light therapy on the face within 3 months of study start. Subject is currently enrolled in an investigational drug or device study. Subject has used an investigational drug or investigational device treatment within 30 days prior to first application of the test article. Subject has used vasodilators or adrenergic blocking agents within 6 weeks of study start (except subjects on stable dose for greater than 3 months). Subject has active ocular rosacea and/or blepharitis/meibomianitis requiring treatment by an ophthalmologist. Subject has previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics or use of the components of PDI-320.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDI-320<br>Foam, twice daily for up to 12 weeks | Drug: PDI-320<br> <br> |
| Experimental: PDI-320 Monad #1<br>Foam, twice daily for up to 12 weeks | Drug: PDI-320 Monad #1<br> <br> |
| Experimental: PDI-320 Monad #2<br>Foam, twice daily for up to 12 weeks | Drug: PDI-320 Monad #2<br> <br> |
| Placebo Comparator: Vehicle<br>Foam, twice daily for up to 12 weeks | Drug: Vehicle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success Rate based on change in Investigator's Global Assessment (IGA) | IGA Score Success Rate is defined as the percentage of subjects who achieve Clear (score = 0) or Almost Clear (score = 1) and have at least a 2-grade improvement on the IGA score at the End of Treatment. IGA score is used to evaluate the overall severity of rosacea using a 5-point scale from 0 (clear) to 4 (severe). | Baseline and End of Treatment (up to 12 weeks) | 
| Absolute change in inflammatory lesion count | Inflammatory lesions include papules and pustules on the face, and are counted by study personnel. | Baseline and End of Treatment (up to 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success Rate based on change in IGA (interim time points) | IGA Score Success Rate is the same as defined in the Primary Outcome Measures. | Baseline, Week 4 and Week 8 | 
| Absolute change in inflammatory lesion count (interim time points) | Inflammatory lesions include papules and pustules on the face, and are counted by study personnel. | Baseline, Week 4 and Week 8 | 
| Change in erythema severity | The investigator will assess the erythema (skin redness) on the entire face, using a grading scale from 0 (none) to 4 (very severe) | Baseline and End of Treatment (up to 12 weeks) | 
| Change in telangiectasia severity | The investigator will assess telangiectasia (small dilated blood vessels near the surface of the skin) on the face, using a grading scale of 0 (none) to 3 (severe). | Baseline and End of Treatment (up to 12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Foam, PreCision, PDI-320