A multicenter, placebo-controlled, double-blind clinical trial assessing the effects of a multicomponent nutritional supplement for treating photoaged skin in healthy women.

BACKGROUND: Dietary or supplementary intake of nutrients and other ingredients positively affects skin appearance. AIMS: Evaluate a multicomponent nutritional supplement on photoaged skin. PATIENTS/METHODS: This multicenter, double-blind, placebo-controlled trial randomized healthy 35- to 65-year-old women with Fitzpatrick skin types I-IV and Glogau classification types II-III to a multicomponent nutritional supplement or placebo for 24 weeks. The primary endpoint was Investigator Global Assessment of overall facial appearance at week 24. Secondary endpoints included investigator- and subject-rated assessments of the face, décolletage, and hands; facial photography assessments (conducted by an independent panel of dermatologists); and instrumental measures. Analysis of variance was used to assess between-group differences (P ≤ 0.05). RESULTS: Of 194 randomized subjects, 171 completed the study. Subjects had a mean age of 53 years and were primarily white (81%), had Glogau II (58%) and Fitzpatrick III (45%; significantly more supplement subjects had Fitzpatrick III [54%] vs. placebo [35%]; P = 0.039). At week 24, Investigator Global Assessment of overall facial appearance was numerically but not statistically better for supplement over placebo (mean difference: 0.14 [95% confidence interval: -0.16-0.44]; P = 0.358). A significant treatment-by-site interaction (P = 0.073) was observed; by-site analyses revealed a significant difference at one of three geographical sites for supplement vs. placebo (P = 0.001). Differences on secondary endpoints were generally not significant. CONCLUSIONS: In the first multicenter study conducted with this multicomponent nutritional supplement, no significantly greater effects vs. placebo were observed on the primary endpoint, perhaps because of significant between-site variability.

A Review of Clinical Trials Conducted With Oral, Multicomponent Dietary Supplements for Improving Photoaged Skin.

Although the FDA does not require documentation of efficacy of dietary supplements, prospective clinical studies, including randomized controlled trials, have been conducted with individual micronutrients alone and in combination with other ingredients for promoting skin health. Proposed mechanisms include antioxidation, anti-inflammation, photoprotection, collagen formation, reductions in matrix metalloproteinases, and other effects on photoaging. Literature searches were conducted to identify clinical trials assessing multicomponent dietary supplement formulations on photoaging outcomes. Sixteen studies of various nutrient and non-nutrient ingredients, including essential micronutrients (vitamins, minerals), plant extracts (polyphenols, carotenoids), and marine- or animal-derived ingredients, were identified. Studies were single center, 2-12 months in duration, primarily enrolled women, and evaluated numerous outcomes, including investigator/subject assessments and instrumental/objective measures. Methods to control for potential confounders were implemented in some studies, including limiting sun exposure, cosmetic procedures, and changes in dietary habits/body weight. Given the range of different products, clinical/methodologic heterogeneity, insufficient detail in reporting, and lack of comparable outcome measures, quantitative analysis of results was not possible. Results of individual studies revealed significant improvements from baseline for the dietary supplement group(s) on ≥ 1 endpoint across all studies; significant differences from placebo were observed in 7 of 12 controlled studies (although only 1 study designated a prospectively defined primary endpoint). Most products had only been tested in 1 study; confirmatory studies were rarely conducted per the publicly available literature. Meaningful assessment of dietary supplements, which typically contain nutrients found in the diet, requires unique methodologic considerations and endpoints appropriate for measuring changes that are more subtle and gradual than those observed with topical/injectable products. Although definitive conclusions could not be drawn from the existing evidence, available data are supportive of beneficial effects of oral multicomponent supplements on skin health. Confirmation of positive effects with the same formulation/endpoint from more than a single study/investigator is needed.

Validated composite assessment scales for the global face.

BACKGROUND: Twenty grading scales have been developed to assess age-related facial changes. Until now, the validity with regard to the patient's actual age and the clinical importance of combined measurement tools to describe facial aging was unclear. OBJECTIVE: To investigate the reliability and validity of a total face score and three global face assessment scales for estimated age, estimated aesthetic treatment effort, and signs of aging in the facial units. MATERIALS AND METHODS: Descriptive, reliability, correlation, and principal component analyses based on the assessment of 50 subjects by 12 raters using the 20 grading scales and the global face assessment scales. RESULTS: Inter- and intrarater reliability was high for the total face score and for the scales on estimated age and aesthetic treatment effort. Actual age was highly correlated with these three measures. Facial aging was indicated particularly by scales of the lower face. CONCLUSION: The aesthetic grading scales and global scales on estimated age and aesthetic treatment effort are reliable and valid instruments. The results suggest that a more-comprehensive evaluation of the human face and its age-related changes can help to identify important areas of facial aging and to define optimal aesthetic treatment strategies.

Validated assessment scales for the upper face.

BACKGROUND: Age-related upper face changes such as wrinkles, lines, volume loss, and anatomic alterations may affect quality of life and psychological well-being. The development of globally accepted tools to assess these changes objectively is an essential contribution to aesthetic research and routine clinical medicine. OBJECTIVE: To establish the reliability of several upper face scales for clinical research and practice: forehead lines, glabellar lines, crow's feet (at rest and dynamic expression), sex-specific brow positioning, and summary scores of forehead and crow's feet areas and of the entire upper face unit. METHODS AND MATERIALS: Four 5-point photonumerical rating scales were developed to assess glabellar lines and sex-specific brow positioning. Twelve experts rated identical upper face photographs of 50 subjects in two separate rating cycles using all eight scales. Responses of raters were analyzed to assess intra- and interrater reliability. RESULTS: Interrater reliability was substantial for all upper face scales, aesthetic areas, and the upper face score except for the brow positioning scales. Intrarater reliability was high for all scales and resulting scores. CONCLUSION: Except for brow positioning, the upper face rating scales are reliable tools for valid and reproducible assessment of the aging process.

Validated assessment scales for the mid face.

BACKGROUND: The improvement of aesthetic treatment options for age-related mid face changes, such as volume loss, and the increase in patient expectations necessitates the development of more-complex and globally accepted assessment tools. OBJECTIVE: To develop three grading scales for objective assessment of the infraorbital hollow and upper and lower cheek fullness and to establish the reliability of these scales for clinical research and practice. METHODS AND MATERIALS: Three 5-point rating scales were developed to assess infraorbital hollow and upper and lower cheek fullness objectively. Twelve experts rated identical mid face photographs of 50 subjects in two separate rating cycles using the mid face scales. Test responses of raters were analyzed to assess intra- and interrater reliability. RESULTS: Interrater reliability was substantial for the infraorbital hollow, upper cheek fullness, and lower cheek fullness scales. Intrarater reliability was high for all three scales. Both of the cheek fullness scales yielded higher reliabilities when three rather than two views were used to assess the volume changes of the cheek. CONCLUSION: The mid face scales are reliable tools for valid and reproducible assessment of age-related mid face changes.

Validated assessment scales for the lower face.

BACKGROUND: Aging in the lower face leads to lines, wrinkles, depression of the corners of the mouth, and changes in lip volume and lip shape, with increased sagging of the skin of the jawline. Refined, easy-to-use, validated, objective standards assessing the severity of these changes are required in clinical research and practice. OBJECTIVE: To establish the reliability of eight lower face scales assessing nasolabial folds, marionette lines, upper and lower lip fullness, lip wrinkles (at rest and dynamic), the oral commissure and jawline, aesthetic areas, and the lower face unit. METHODS AND MATERIALS: Four 5-point rating scales were developed to objectively assess upper and lower lip wrinkles, oral commissures, and the jawline. Twelve experts rated identical lower face photographs of 50 subjects in two separate rating cycles using eight 5-point scales. Inter- and intrarater reliability of responses was assessed. RESULTS: Interrater reliability was substantial or almost perfect for all lower face scales, aesthetic areas, and the lower face unit. Intrarater reliability was high for all scales, areas and the lower face unit. CONCLUSION: Our rating scales are reliable tools for valid and reproducible assessment of the aging process in lower face areas.

Validated assessment scale for neck volume.

BACKGROUND: Sagging of the neck aesthetic area is an important indicator of age. The development of complex and globally accepted tools for proper assessment of the change in neck volume is an essential contribution to aesthetic research and the routine clinical setting. OBJECTIVE: To develop a grading scale for the objective assessment of the neck volume and to establish the reliability of this scale for clinical research and practice. MATERIALS AND METHODS: A 5-point rating scale was developed to assess neck volume objectively. Twelve experts rated frontal and lateral neck photographs of 50 subjects in two separate rating cycles using the neck volume scale. Responses of raters were analyzed to assess inter- and intrarater reliability. RESULTS: Interrater reliability for the neck volume scale was almost perfect, with intraclass correlation coefficients for the first and second rating cycles of 0.85 and 0.84, respectively. Intrarater reliability for the neck volume scale was high (0.90) and Pearson correlation coefficients ranged between 0.88 and 0.95 and were statistically significant. CONCLUSION: The neck volume scale demonstrates optimal reliability for clinical research and practice.

A validated grading scale for forehead lines.

BACKGROUND: As with other facial wrinkles, the gradual loss and disorganization of collagen fibers and elastin, connective tissues that provide underlying support for skin, cause horizontal forehead rhytides in large part. OBJECTIVES: To develop the Forehead Lines Grading Scale for objective quantification of horizontal forehead rhytides at rest and with expression and to establish the reliability of this photonumeric scale for clinical research and practice. MATERIALS AND METHODS: The Forehead Lines Grading Scale is a 5-point photonumeric rating scale that was developed to objectively quantify resting (static) and hyperkinetic (dynamic) forehead lines. Inter- and intrarater variability was assessed by computing intraclass correlation coefficients. RESULTS: The agreement between the experts was highly significant. Bubble plots (bivariate scatter plots) demonstrated linearity in judgment by the experts. CONCLUSION: The 5-point photonumeric scale generated spans the severity of forehead lines for which patients commonly seek correction. The scale is well stratified for consistent rating.

A validated brow positioning grading scale.

BACKGROUND: One of the first areas to show facial aging is the periorbital region, where brow malposition contributes to the overall appearance of aging. Movement and positioning of the brows are also sex specific. Men may desire a low brow, whereas women may prefer high, arched brows. OBJECTIVES: To develop the Brow Positioning Grading Scale for objective quantification of eyebrow position and to establish the reliability of this photonumeric scale for clinical research and practice. MATERIALS AND METHODS: A 5-point photonumeric rating scale was developed to objectively quantify positioning of eyebrows at rest. Nine experts rated photographs of 35 subjects twice with regard to positioning of the eyebrow in comparison with morphed images. Inter- and intrarater variability was assessed by computing intraclass correlation coefficients. RESULTS: Bubble plots (bivariate scatter plots) demonstrated linearity in judgment by the experts. The test-retest correlation coefficients were acceptable for each expert. CONCLUSION: The 5-point photonumeric scale generated spans the positioning of the eyebrow for which patients commonly seek correction. The scale is well stratified for consistent rating.

A validated lip fullness grading scale.

OBJECTIVES: To develop the Lip Fullness Grading Scale for objective quantification of lip volume for a reliable assessment and to establish the reliability of this photonumeric scale for clinical research and practice. MATERIALS AND METHODS: A 5-point photonumeric rating scale was developed to objectively quantify fullness of upper and lower lip separately. Nine experts rated photographs of 35 subjects, twice, separately for upper and lower lip. Inter- and intrarater variability was assessed by computing intraclass correlation coefficients. RESULTS: Agreement between the experts was high. Bubble plots (bivariate scatter plots) demonstrated linearity in judgment by the experts. CONCLUSION: The 5-point photonumeric scale generated spans the fullness of the upper and lower lip for which patients commonly seek correction. This scale is well stratified, with low intra- and interrater variability.

A validated grading scale for marionette lines.

BACKGROUND: Melomental folds, or marionette lines, are one of the consequences of facial aging. The curvilinear wrinkles formed because of facial movements and the aging process extend downward from the oral commissures. OBJECTIVES: To develop the Marionette Lines Grading Scale for objective quantification of the severity of melomental folds and to establish the reliability of this photonumeric scale for clinical research and practice. MATERIALS AND METHODS: A 5-point photonumeric rating scale was developed to objectively quantify the severity of melomental folds. Nine experts rated photographs of 35 subjects, twice, with regard to marionette lines in comparison with morphed images. Inter- and intrarater variability was assessed by computing intraclass correlation coefficients. RESULTS: The agreement between the experts was high. Bubble plots (bivariate scatter plots) demonstrated linearity in judgment by the experts. CONCLUSION: The 5-point photonumeric scale generated spans the severity of marionette lines for which patients commonly seek correction. The scale is well stratified for consistent rating.

A validated hand grading scale.

BACKGROUND: Following the popularity of facial cosmetic procedures to reverse the signs of aging, cosmetic procedures that rejuvenate the hand are being sought. Irregular surface pigmentation, prominence of superficial veins and tendons, thinning of the dermis, and loss of subcutaneous fat typically characterize aging of the hand. OBJECTIVES: To develop the Hand Grading Scale for objective quantification of the severity of hand aging and to establish the reliability of this photonumeric scale for clinical research and practice. MATERIALS AND METHODS: The Hand Grading Scale is a 5-point photonumeric rating scale that was developed to objectively quantify the severity of aging of the hand. Nine experts rated photographs of 35 subjects, twice, with regard to the aspect "hand aging" in comparison with morphed images. Inter- and intrarater variability was assessed by computing intraclass correlation coefficients. RESULTS: The agreement between the experts was considerably high. Bubble plots (bivariate scatter plots) demonstrated linearity in judgment by the experts. CONCLUSION: The 5-point photonumeric scale generated spans the severity of hand aging for which patients most commonly seek correction. The scale is well stratified for consistent rating.

A validated grading scale for crow's feet.

OBJECTIVE: To develop the Crow's Feet Grading Scale for objective quantification of the severity of lateral canthal lines and to establish the reliability of this photonumeric scale for clinical research and practice. MATERIALS AND METHODS: A 5-point photonumeric rating scale was developed to objectively quantify the severity of lateral canthal lines at rest and at maximum contracture of the orbicularis oculi. Nine experts rated photographs of 35 subjects, twice, with regard to the aspect crow's feet in comparison with morphed images. Inter- and intrarater variability was assessed by computing intraclass correlation coefficients. RESULTS: The agreement between the experts was significantly high. Furthermore, the test-retest correlation coefficients were high for each expert after an overnight interval, demonstrating low inter- and intraevaluator variability. CONCLUSION: The 5-point photonumeric scale generated spans the severity of the type of crow's feet for which patients most commonly seek correction. The scale is well stratified for consistent rating.