and vitamins C and E. The wrinkle treatment contained 0.3% retinyl
propionate). This study was particularly interesting because it effectively compared the clinical efficacy of an OTC product with that of tretinoin, which is often considered the benchmark prescription
topical therapy for improving facial wrinkles.
This was an 8-week, randomized parallel-group study. A total of 196 women with moderate to moderately severe periorbital wrinkles were evaluated. A total of 99 subjects on the treatment regimen were compared with subjects using 0.02% tretinoin plus moisturizing SPF 30 sunscreen (n=97). Subject cohorts (n=25) continued treatment for an additional 16 weeks. Changes
in facial wrinkles were assessed by expert grading, image analysis of digital images, and a self-assessment questionnaire.
The treatment regimen significantly improved the appearance of wrinkles after 8 weeks relative to tretinoin. Also, the treatment
regimen was better tolerated than tretinoin in all of the measures. Some potential weaknesses in this study include the fact that tretinoin is more irritating to the skin than the treatment
products and thus could have affected the results; subjects were not blinded, which could have affected the subjects' self-assessments; and no histological markers were evaluated.
Another interesting study from 2009 that evaluated a topical medication with rigorous trials of efficacy looked at topical fluorouracil
for actinic keratoses and photoaging.42 Although this study did not evaluate an OTC product, it still can serve as a model for other future studies.
The study evaluated gene and protein expression of molecular effectors of epidermal injury, inflammation, and extracellular matrix remodeling 24 hours after fluorouracil treatment. It also measured clinical improvement by evaluators, photography, and patient questionnaires. The study found that one day after the final fluorouracil treatment, gene expression of the effectors of epidermal injury (keratin 16), inflammation (interleukin 1Β), and extracellular matrix degradation (MMPs 1 and 3) was significantly
increased. Types I and III procollagen messenger ribonucleic acid were induced at week 4 (7-fold and 3-fold, respectively). Type I procollagen protein levels were increased 2-fold at week 24.
Overall, it seems that there is a great necessity for more rigorous studies of OTC skincare products. This is especially imperative because these products comprise such a significant percentage of the enormous cosmeceutical industry. The average woman in the United States uses at least 25 products containing hundreds of the ingredients on her skin daily. Very few of these OTC products,
which may cost hundreds of dollars, have been subjected to rigorous controlled trials of efficacy. With the current lack of comprehensive information on these products, it is extremely difficult for both clinicians and consumers to ascertain their efficacy.
Future studies can ameliorate this problem by not only evaluating products for clinical efficacy but also using histologic and gene and protein expression to ascertain their effectiveness.
The authors have no relevant conflicts of interest to disclose.
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