scale with zero representing no difference between the two photographs. A score of +1 to +6 is assigned when the end-of-treatment photograph is perceived to be better and a score of -1 to -6 when the baseline photograph is perceived to be better.
Trials of isotretinoin have successfully utilized the clinical panel and demonstrated the therapeutic effect compared to vehicle (10,11).
If the above-described pharmaceutical^ oriented trials demonstrate significant effect, claim substantiation may be relatively easy and clear-cut.
However, distinction may be made among the various aspects of a claim for a product. There are, in each country, very different cultural and legal perspectives dictating what can be stated about a product designated for photoaging. These claims are generally related to the broad perception of whether the cosmetic or skin-care aspects, the potential cosmeceutical action, or a proven pharmaceutical effect is being claimed and advertised. In this regard, everything from consumer statements, consumer panel testing, instrumentation results, clinical testing results, to absence or presence of statements regarding alteration of structure or function of the skin must be considered in evaluating, regulating, and advertising a product.
With no other methodology is there the same potential for accurate, precise, reproducible, consistent data to used appropriately or to be nefariously manipulated to purport therapeutic effect as with the now-available and sophisticated instrumentation (12). Evaluation of the obtained instrumental data must take place in a clinically appropriate context for them to be truthful and meaningful (Table 5).
Table 5 Instrumentation
Optical profilometry Fluorescent photography Ultrasound
Transepidermal water loss
Skin hydration by capacitance/conductance
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