Treatment (Visits Sample Clauses

Treatment (Visits. Subjects that did not experience significant pain or skin sensitivity in response to the test spots can receive treatments. Each subject will be enrolled and scheduled for two treatments, three weeks apart and return for a follow-up visit three days after the second treatment for evaluation of the treatment area. The following procedures and assessments are required at the treatment visits:  Confirm continued eligibility regarding inclusion/exclusion criteria  Review any changes in medication, health status or AE from last visit  Assessment of adverse events including a photograph of the affected treatment area if an adverse event occurred  Assessment of concomitant medications  Assign randomized treatment (after 1st treatment visit only)  Apply a topical anesthetic preparation over the treatment areas, if required. (If used, record in the CRF.) No lotion, gel or coupling medium is to be used in this treatment. The distal part of the applicator should be clean and dry before fitting it with a new 160 pins tip. The skin in the treated area should also be cleaned well (for removal of any lotions, make-up residues, topical anesthetic cream, etc.) and patted dry. Hairs that exist in the areas should be shaved off.  Treatment should be performed while the subject is lying down comfortably; the operator should have easy access to the subject’s treatment area.  Areas of dental crowns, caps, braces, or other metal dental implants may be more sensitive to treatment and the clinician may use dental rolls, gauze or a tongue depressor to isolate the area and make the treatment more comfortable (if the face is treated).  Treatment of subjects in hair-bearing areas may result in some damage to the follicles and subsequent loss of hair. Avoid the ▇▇▇▇▇ area (if face is treated) and other hair growing zones if the patient doesn’t wish to have reduction of the hair growth. This treatment may also result in in- grown hairs.  The applicator should be held perpendicular to and in close contact with the skin.  Pressing the trigger will release the RF energy to the skin, creating a stamped imprint in a shape and intensity depending on energies.  The immediate responses, indicative of the desired effect, are erythema and edema in the immediate area of the stamp and possibly also around it. The edema usually appears 1-2 minutes post-treatment and reaches its peak (of up to moderate edema) within 30 minutes. It should be noted that erythema is not easily noticeable, if...