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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • California
      • San Diego, California, United States
        • Therapeutics Clinical Research
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Academic Dermatology Associates

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PDI-320
Foam, twice daily for up to 12 weeks
Drug: PDI-320
Experimental: PDI-320 Monad #1
Foam, twice daily for up to 12 weeks
Drug: PDI-320 Monad #1
Experimental: PDI-320 Monad #2
Foam, twice daily for up to 12 weeks
Drug: PDI-320 Monad #2
Placebo Comparator: Vehicle
Foam, twice daily for up to 12 weeks
Drug: Vehicle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PreCision Dermatology, Inc.

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 29, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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