Dr Koo wants you to know that research is continually being conducted for the safety and discovery of new products that help reduce wrinkles and maintain healthy skin. The following is the continuation of the her blog with the study by Dr Mary Lupo.

Because of the differences in appearance between the two products, each study site had two investigators: a treating investigator who was not blinded and an evaluating investigator who was. To maintain this blinding, the evaluating investigator was not present during treatment. In addition, the subjects were blindfolded during their treatments to ensure that they too were blinded as to treatment type in each nasolabial fold. The treating investigator injected the appropriate amount of product necessary to achieve full correction but did not overcorrect. Up to two touch-up treatments were allowed. The evaluating investigator assessed the level of correction at 2 and 4 weeks after the initial treatment and, if less than optimal, the treating investigator performed the touch-up with the same assigned filler(s).

Every 4 weeks for up to 24 weeks after the last treatment, subjects were followed for assessment of nasolabial fold severity. The evaluating and treating investigators used the validated, static, five-point Wrinkle Assessment Scale with a photographic guide to score the folds as 0 (none), no wrinkle; 1 (mild), shallow, just perceptible wrinkle; 2 (moderate), moderately deep wrinkle; 3 (severe), deep wrinkle, well-defined edges but not overlapping; or 4 (extreme) very deep wrinkle, redundant fold, overlapping skin. Subjects also performed a self-assessment at each visit using the same five-point Wrinkle Assessment Scale but without photographs. At study end while still blinded to treatment assignment, subjects were asked which filler, if any, they preferred. Treatment site reactions were reported by subjects through day 13 after each treatment, and any additional adverse events reported by the subjects or observed by the investigators were also recorded.

At completion of the 24-week study, subjects were offered the opportunity to return at their convenience for a complimentary repeated treatment with the filler of their choice, and an additional effectiveness assessment was performed just before this treatment. At a subset of investigational sites, an extended follow-up study was initiated to assess injection volume and longevity of correction for repeated treatment. Because this post-24-week period was not blinded, all assessments were performed by the treating investigators, whose evaluations during the pivotal study mirrored those of the evaluating investigators. Follow-up visits for effectiveness assessments after repeated treatment occurred at 4, 12, and 24 weeks after repeated treatment, and an amendment to the extended study protocol allowed even further evaluations at 36 and 48 weeks after repeated treatment. The protocols and amendments for both studies were approved by the applicable institutional review boards, and subjects provided written informed consent for each study in which they participated.

Continued on Next Blog

Tags: and Wrinkles, Facial Creases, Facial Wrinkles, Lines

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