Back to resultsAn Evaluation of PDI-320 in Comparison to Its Monads in Adults With Rosacea
Primary Purpose
Rosacea
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PDI-320
PDI-320 Monad #1
PDI-320 Monad #2
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea focused on measuring PreCision, PDI-320, Foam
Eligibility Criteria
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.
Sites / Locations
- Therapeutics Clinical Research
- Academic Dermatology Associates
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
PDI-320
PDI-320 Monad #1
PDI-320 Monad #2
Vehicle
Arm Description
Foam, twice daily for up to 12 weeks
Foam, twice daily for up to 12 weeks
Foam, twice daily for up to 12 weeks
Foam, twice daily for up to 12 weeks
Outcomes
Primary Outcome Measures
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).
Absolute change in inflammatory lesion count
Inflammatory lesions include papules and pustules on the face, and are counted by study personnel.
Secondary Outcome Measures
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.
Absolute change in inflammatory lesion count (interim time points)
Inflammatory lesions include papules and pustules on the face, and are counted by study personnel.
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)
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).
Full Information
NCT ID
NCT01828177
First Posted
April 3, 2013
Last Updated
May 27, 2014
Sponsor
PreCision Dermatology, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01828177
Brief Title
An Evaluation of PDI-320 in Comparison to Its Monads in Adults With Rosacea
Official Title
A Multicenter Randomized Evaluator-Blinded Vehicle-Controlled Parallel Group Evaluation of Twice Daily PDI-320 in Comparison to Its Monads in Adults With Rosacea
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PreCision Dermatology, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
Keywords
PreCision, PDI-320, Foam
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PDI-320
Arm Type
Experimental
Arm Description
Foam, twice daily for up to 12 weeks
Arm Title
PDI-320 Monad #1
Arm Type
Experimental
Arm Description
Foam, twice daily for up to 12 weeks
Arm Title
PDI-320 Monad #2
Arm Type
Experimental
Arm Description
Foam, twice daily for up to 12 weeks
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Foam, twice daily for up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
PDI-320
Intervention Type
Drug
Intervention Name(s)
PDI-320 Monad #1
Intervention Type
Drug
Intervention Name(s)
PDI-320 Monad #2
Intervention Type
Drug
Intervention Name(s)
Vehicle
Primary Outcome Measure Information:
Title
Treatment "Success Rate" based on change in Investigator's Global Assessment (IGA)
Description
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).
Time Frame
Baseline and End of Treatment (up to 12 weeks)
Title
Absolute change in inflammatory lesion count
Description
Inflammatory lesions include papules and pustules on the face, and are counted by study personnel.
Time Frame
Baseline and End of Treatment (up to 12 weeks)
Secondary Outcome Measure Information:
Title
Treatment "Success Rate" based on change in IGA (interim time points)
Description
IGA Score Success Rate is the same as defined in the Primary Outcome Measures.
Time Frame
Baseline, Week 4 and Week 8
Title
Absolute change in inflammatory lesion count (interim time points)
Description
Inflammatory lesions include papules and pustules on the face, and are counted by study personnel.
Time Frame
Baseline, Week 4 and Week 8
Title
Change in erythema severity
Description
The investigator will assess the erythema (skin redness) on the entire face, using a grading scale from 0 (none) to 4 (very severe)
Time Frame
Baseline and End of Treatment (up to 12 weeks)
Title
Change in telangiectasia severity
Description
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).
Time Frame
Baseline and End of Treatment (up to 12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syd Dromgoole, PhD
Organizational Affiliation
Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Evaluation of PDI-320 in Comparison to Its Monads in Adults With Rosacea
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