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Some practitioners report amplification of fibroblast response by an estimated 40 to 60 percent compared to microneedling alone, based on observational clinical data, though controlled trial data at this scale is still accumulating

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The existence of this Phase 2 trial — even outside the US regulatory framework — is likely to be cited in PCAC proceedings as evidence that formal controlled evaluation is now underway, which is one of the factors considered in the four-factor PCAC analysis for clinical significance