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

NCT01828177 | Unknown Phase 2

• 1 other identifier: 172-7451-201
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Rosacea

Keywords

PreCision; PDI-320; Foam

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Treatment "Success Rate" based on change in IGA (interim time points)

  Baseline, Week 4 and Week 8

• Absolute change in inflammatory lesion count (interim time points)

  Baseline, Week 4 and Week 8

• Change in erythema severity

  Baseline and End of Treatment (up to 12 weeks)

• Change in telangiectasia severity

  Baseline and End of Treatment (up to 12 weeks)

Study Arms (4)

PDI-320

EXPERIMENTAL

Foam, twice daily for up to 12 weeks

Drug: PDI-320

PDI-320 Monad #1

EXPERIMENTAL

Foam, twice daily for up to 12 weeks

Drug: PDI-320 Monad #1

PDI-320 Monad #2

EXPERIMENTAL

Foam, twice daily for up to 12 weeks

Drug: PDI-320 Monad #2

Vehicle

PLACEBO COMPARATOR

Foam, twice daily for up to 12 weeks

Drug: Vehicle

Interventions

PDI-320 DRUG

PDI-320

PDI-320 Monad #1 DRUG

PDI-320 Monad #1

PDI-320 Monad #2 DRUG

PDI-320 Monad #2

Vehicle DRUG

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PreCision Dermatology, Inc.: lead

Study Sites (2)

Therapeutics Clinical Research

San Diego, California, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Syd Dromgoole, PhD

  Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 10, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

US (2)