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

NCT ID: NCT01828177

Last Updated: 2014-05-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PDI-320

Foam, twice daily for up to 12 weeks

Group Type: EXPERIMENTAL

PDI-320

Intervention Type: DRUG

PDI-320 Monad #1

Foam, twice daily for up to 12 weeks

Group Type: EXPERIMENTAL

PDI-320 Monad #1

Intervention Type: DRUG

PDI-320 Monad #2

Foam, twice daily for up to 12 weeks

Group Type: EXPERIMENTAL

PDI-320 Monad #2

Intervention Type: DRUG

Vehicle

Foam, twice daily for up to 12 weeks

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Interventions

PDI-320

Intervention Type: DRUG

PDI-320 Monad #1

Intervention Type: DRUG

PDI-320 Monad #2

Intervention Type: DRUG

Vehicle

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PreCision Dermatology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Syd Dromgoole, PhD

Role: STUDY_DIRECTOR

Therapeutics, Inc.

Locations

Therapeutics Clinical Research

San Diego, California, United States

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

172-7451-201

Identifier Type: -

Identifier Source: org_study_id