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

PreCision Dermatology

Status and phase: Unknown; Phase 2

Conditions: Rosacea

Treatments: Drug: PDI-320 Monad #1; Drug: PDI-320; Drug: Vehicle; Drug: PDI-320 Monad #2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01828177

172-7451-201

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups, including a placebo group

PDI-320

Experimental group

Description:

Foam, twice daily for up to 12 weeks

Treatment:

Drug: PDI-320

PDI-320 Monad #1

Experimental group

Description:

Foam, twice daily for up to 12 weeks

Treatment:

Drug: PDI-320 Monad #1

PDI-320 Monad #2

Experimental group

Description:

Foam, twice daily for up to 12 weeks

Treatment:

Drug: PDI-320 Monad #2

Vehicle

Placebo Comparator group

Description:

Foam, twice daily for up to 12 weeks

Treatment:

Drug: Vehicle