- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01828177
An Evaluation of PDI-320 in Comparison to Its Monads in Adults With Rosacea
May 27, 2014 updated by: PreCision Dermatology, Inc.
A Multicenter Randomized Evaluator-Blinded Vehicle-Controlled Parallel Group Evaluation of Twice Daily PDI-320 in Comparison to Its Monads in Adults With Rosacea
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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San Diego, California, United States
- Therapeutics Clinical Research
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-
New Mexico
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Albuquerque, New Mexico, United States
- Academic Dermatology Associates
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PDI-320
Foam, twice daily for up to 12 weeks
|
|
Experimental: PDI-320 Monad #1
Foam, twice daily for up to 12 weeks
|
|
Experimental: PDI-320 Monad #2
Foam, twice daily for up to 12 weeks
|
|
Placebo Comparator: Vehicle
Foam, twice daily for up to 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment "Success Rate" based on change in Investigator's Global Assessment (IGA)
Time Frame: Baseline and End of Treatment (up to 12 weeks)
|
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
Time Frame: Baseline and End of Treatment (up to 12 weeks)
|
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)
Time Frame: Baseline, Week 4 and Week 8
|
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)
Time Frame: Baseline, Week 4 and Week 8
|
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
Time Frame: Baseline and End of Treatment (up to 12 weeks)
|
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
Time Frame: Baseline and End of Treatment (up to 12 weeks)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Anticipated)
June 1, 2014
Study Completion (Anticipated)
June 1, 2014
Study Registration Dates
First Submitted
April 3, 2013
First Submitted That Met QC Criteria
April 5, 2013
First Posted (Estimate)
April 10, 2013
Study Record Updates
Last Update Posted (Estimate)
May 29, 2014
Last Update Submitted That Met QC Criteria
May 27, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 172-7451-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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