Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation

A fractional ablative DEKA SmartXide Tetra CO2 laser treatment was performed after a 14-day washout period. Subjects were numbed for 1 hour prior to procedure with topical numbing cream (lidocaine 23%, tetracaine 7%). The global face was treated with a single pass. Treatment parameters include power 20 W, spacing 500 um (13% density), Dwell time 1200 us DEKA pulse mode, spray mode on.

Facial cleanser was to be used by subjects twice daily during the 14-day washout period and three times daily during the 14-day post-procedure timeline.

A bland facial moisturizer was to be used by subjects twice daily during the 14-day washout period and three times daily between day 3 and 14 post-procedure. Two pumps were to be applied to the face (avoiding the upper eyelid) after applying the active and comparator.

During the 14-day washout period, a bland sunscreen was to be used by subjects in the morning after cleansing and facial moisturizer application with reapplications as needed throughout the day per FDA recommendations. For days 3-14 post-procedure, the bland sunscreen was to be used daily by subjects in the morning and afternoon after cleansing, split-face application of the active post-procedure cream and comparator anhydrous formulation, and facial moisturizer application.

The basic ointment was used only on the comparator side for three days (72 hours) post-procedure. This was a requirement of the comparator anhydrous formulation.