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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
PreCision Dermatology, Inc.
ClinicalTrials.gov Identifier:
NCT01828177
First received: April 3, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Rosacea
Drug: PDI-320
Drug: PDI-320 Monad #1
Drug: PDI-320 Monad #2
Drug: Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by PreCision Dermatology, Inc.:

Primary Outcome Measures:
  • Treatment "Success Rate" based on change in Investigator's Global Assessment (IGA) [ Time Frame: Baseline and End of Treatment (up to 12 weeks) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and End of Treatment (up to 12 weeks) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, Week 4 and Week 8 ] [ Designated as safety issue: No ]
    IGA Score Success Rate is the same as defined in the Primary Outcome Measures.

  • Absolute change in inflammatory lesion count (interim time points) [ Time Frame: Baseline, Week 4 and Week 8 ] [ Designated as safety issue: No ]
    Inflammatory lesions include papules and pustules on the face, and are counted by study personnel.

  • Change in erythema severity [ Time Frame: Baseline and End of Treatment (up to 12 weeks) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and End of Treatment (up to 12 weeks) ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 200
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828177

Locations
United States, California
Therapeutics Clinical Research
San Diego, California, United States
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Sponsors and Collaborators
PreCision Dermatology, Inc.
Investigators
Study Director: Syd Dromgoole, PhD Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: PreCision Dermatology, Inc.
ClinicalTrials.gov Identifier: NCT01828177     History of Changes
Other Study ID Numbers: 172-7451-201
Study First Received: April 3, 2013
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by PreCision Dermatology, Inc.:
PreCision
PDI-320
Foam

Additional relevant MeSH terms:
Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on July 31, 2014