In the controlled clinical trials, adverse events were monitored in the 161 subjects who used TRI-LUMA Cream once daily during an 8-week treatment period. There were 102 (63%) subjects who experienced at least one treatment-related adverse event during these trials. The most frequently reported events were erythema , desquamation , burning, dryness, and pruritus at the site of application. The majority of these events were mild to moderate in severity. Adverse events reported by at least 1% of patients and judged by the investigators to be reasonably related to treatment with TRI-LUMA Cream from the controlled clinical trials are summarized (in decreasing order of frequency) as follows:
A: Microdermal abrasion machines can only be operated by people with specific theoretical and practical training. Since this procedure is still relatively new, regulations regarding microbrasion certification vary from state to state. Generally speaking, for a person to perform professional in-office micro derma abrasion. one needs to conclude a supervised 14 to 30 hour training and pass a practical exam with the institution offering the course. This institution can be a large spa, a vocational school, a dermatology clinic, a beauty academy or a device manufacturer.