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

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.