A Prospective, Multi-Center Study to Evaluate the Safety and Efficacy of a Vegan Nutraceutical to Improve Hair Growth and Quality in Females Following a Plant-Based Diet

Hair thinning affects upwards of 50% of women by age 50, impacting their social-emotional wellbeing. It is a condition now thought to be driven by a multi-factorial etiology, including diet and nutrition. Women following vegan, vegetarian, or other plant-based diets have specific needs for nutrients traditionally sourced from animals, which could affect hair health. To support hair growth and quality in women following a plant-based diet, a novel vegan nutraceutical (Nutrafol Women's Vegan Capsules, Nutraceutical Wellness, Inc., New York, NY) was evaluated for its ability to support hair health. The objectives of this 6-month, multi-site, single-blind prospective clinical study was to evaluate the safety and efficacy of the nutraceutical to improve hair growth and quality in women consuming a plant-based diet. The primary endpoint in this study was an increase in terminal hair count at day 180 compared with baseline, as assessed through phototrichogram analysis. Ninety-five subjects completed the study. Daily intake of the nutraceutical resulted in a significant increase in the number of terminal hairs at day 90 (P<0.01) and day 180 (P<0.01). There was also an increase in total hair counts (P<0.01), the terminal-to-vellus ratio (P<0.01), and a decrease in shedding (P<0.01). Global Investigator Ratings revealed improved hair growth (P<0.00001) and overall quality (P<0.00001). In-person hair strength and brittleness assessments significantly improved as well (P<0.01 for both). A significant proportion of subjects reported improved hair quality, appearance, texture, and volume. Hair problems affecting the quality of life of the subjects were also reported as improved. This study demonstrated significant improvements in hair growth and quality in a plant-based population with a vegan nutraceutical. ClinicalTrials.gov Identifier: NCT05332743. J Drugs Dermatol. 2024;23(8):661-668.  doi:10.36849/JDD.8421.

Whole-Genome Shotgun Metagenomic Sequencing Reveals Shifts in the Skin Microbiome and Bacteriophages of Psoriasis: An Extended Analysis of Published Data.

Background: Psoriasis is an immune-mediated cutaneous disease that may have shifts in the skin microbiome. Prior research on the skin microbiome in psoriasis has been limited to rRNA based approaches that lack resolution of taxonomic and functional level assessment. Objective: To further illuminate strain and sub-strain level analysis of psoriatic lesions using the CosmosID-HUB Microbiome pipeline. Methods: A previous study completed by Tett et al recruited patients with psoriasis who had skin microbiome samples taken from psoriatic plaques on the ear and the elbow as well as sites on the skin unaffected by psoriasis. They performed whole genome shotgun sequencing and made their dataset publicly available. We analyzed the dataset using the CosmosID-HUB Microbiome pipeline to evaluate the strain and sub-strain taxonomic analysis as well as functional gene profiling. Results: When analyzed with the CosmosID pipeline, both ear and elbow sites in affected areas had decreased alpha diversity compared to unaffected areas. There was an increased relative abundance of Staphylococcus and Corynebacteria at affected sites. We identified distinguishing species and strains of the yeast Malassezia, including M. restricta. that were significantly enriched in healthy elbow samples. Vitamin B12 production genes were not present in psoriatic skin whereas it was present in healthy samples, supporting the notion of relative vitamin B12 deficiency in psoriatic plaques. Phage analysis revealed a greater diversity of Staphylococcus-related phages in unaffected elbow samples. Conclusion: A greater diversity of microbial strains and their functional roles identified in this study may help to tailor treatment for psoriasis.

Correlating the Gut Microbiota and Circulating Hormones with Acne Lesion Counts and Skin Biophysical Features.

Acne vulgaris is a common inflammatory condition that is multi-factorial and impacted by both intrinsic and extrinsic features. Several previous studies have assessed for correlations between factors such as circulating hormones, stress, or the microbiome. However, there have not been any correlations specifically against lesion counts or differentiating correlations between inflammatory and non-inflammatory lesion counts. Here, we correlate several factors against acne lesions. Twenty men and women with mild to moderate acne were recruited, and their hormonal levels and their gut microbiome were collected and correlated against their inflammatory and non-inflammatory lesions of acne. Facial non-inflammatory lesions were weakly correlated to sebum excretion rate and weakly inversely correlated to forehead and cheek hydration. We examined stress through the use of a normalized peak-to-trough ratio (higher numbers indicated less stress), which correlated with skin hydration and inversely correlated with sebum excretion rate. Sebum excretion rate was weakly correlated to testosterone levels, and facial hydration correlated with estradiol levels. Correlations with the gut microbiome showed differential correlations with inflammatory and non-inflammatory lesions, with Clostridium sp AF 23-8 correlating to inflammatory lesion counts, while Actinomyces naeslundii str Howell 279 correlated to non-inflammatory lesions. Overall, measures of stress and circulating hormones correlate to skin biophysical properties and acne lesion counts. Also, different gut bacteria correlate with either inflammatory or non-inflammatory lesion counts. We hope that our findings stimulate further work on the gut-mind-stress-skin axis within acne.

Clinical Efficacy of Topical or Oral Soy Supplementation in Dermatology: A Systematic Review.

Soybean, a legume native to Southeast Asia, serves many nutritional and medical purposes due to its rich source of phytochemicals and its antioxidant activity. Many animal and in vitro studies have demonstrated its potential impact on dermatologic health. The objective of this review is to investigate the clinical response of soy-based oral supplementation or topical application on dermatologic outcomes. A systematic review of studies assessing soy supplementation or application was performed in January 2023. Databases included PubMed, Embase, Cochrane, and Natural Medicines, and studies assessing any formulation that included soybean or associated products were included. Thirty studies met the inclusion criteria and are included in the review; 13 of these studies assessed oral supplementation and 17 assessed topical application. Topical and oral supplementation demonstrated efficacious results for a variety of dermatologic parameters, including chronological or photoaging parameters, skin barrier status, hydration, hyperpigmentation, dermal network composition, erythema, hair and nail parameters, acne lesion counts, and vulvar lichen sclerosis scores. Factors associated with aging, such as wrinkle area and depth, were most frequently assessed among the studies, and both topical and oral studies demonstrated efficacy. Effects are likely mediated by dermal compositional changes, such as increased collagen and/or elastic fiber numbers. Transepidermal water loss measurements, an indicator of skin barrier status, were frequently obtained among the studies, although improvement was more likely achieved with topical application compared to oral supplementation. The results of this review highlight the utility of soy-based products for a variety of dermatologic applications, although future studies are required to determine optimal formulations and application routes for intended outcomes.

Prospective Evaluation of a Topical Botanical Skin Care Regimen on Mild to Moderate Facial and Truncal Acne and Mood.

Acne vulgaris is a common inflammatory condition that can be associated with profound psychosocial impacts. Conventional treatment includes topical retinoids, benzoyl peroxide, and antimicrobials, and some may cause irritation and skin dryness. In this 8-week open-label study, we examined the effects of a botanical skin care regimen (Codex Labs Shaant Balancing regimen) on mild to moderate facial and truncal acne. Twenty-four male and female subjects between the ages of 12 and 45 years were assessed for eligibility, 20 were enrolled, and 15 completed all study visits. Facial and truncal acne lesion counts, skin hydration, sebum excretion rate, and mood were assessed at baseline, week 4, and week 8. Total facial lesion counts (inflammatory and non-inflammatory lesions) decreased by 20.5% at week 4 (p = 0.06) and by 25.2% at week 8 (p < 0.05). Inflammatory lesion counts on the trunk were found to decrease at week 8 relative to baseline by 48% (p < 0.05). Forehead sebum excretion rate decreased by 40% at week 4 (p = 0.07) and 22% at week 8 (p = 0.08), and cheek skin hydration increased by 27.6% at week 4 (p = 0.14) and 65% at week 8 (p = 0.10). Participants also experienced significant improvement in components of a positive effect, such as feeling "strong" and "inspired", and a decrease in negative effects, such as feeling "irritable." Overall, the botanical skin care regimen was found to be well-tolerated. Our study suggests that a botanical skin care regimen may reduce facial and truncal acne lesion counts, increase skin hydration, reduce sebum production, and augment positive effects and moods in those with mild to moderate facial and truncal acne.

A review of the use of beeswax in skincare.

BACKGROUND: Beeswax is a naturally occurring product secreted from worker bees that has varied uses in modern day. In skincare, its function ranges from its role as an occlusive, helping to create a semi-occlusive skin barrier that minimizes transepidermal water loss; as a humectant, locking in hydration; and an emollient to soften and soothe the skin. As a natural substance, its use has been shown to help alleviate symptoms associated with common cutaneous conditions like dermatitis, psoriasis, and overgrowth of normal skin flora. AIMS: In this narrative review, we aim to describe current uses of beeswax in skincare that has been published in the literature. MATERIALS AND METHODS: A review of beeswax related publications was performed by searching the PubMed database studies. RESULTS: A total of five clinical studies were included with three studies on animals and two studies in humans. DISCUSSION: Several studies show the benefits of topical beeswax in supporting the skin barrier. CONCLUSION: Beeswax can be a low-cost, natural ingredient for use in products. Further studies with topical beeswax are warranted.

The Effects of a Fasting Mimicking Diet on Skin Hydration, Skin Texture, and Skin Assessment: A Randomized Controlled Trial.

Diet and nutrition have been shown to impact dermatological conditions. This has increased attention toward integrative and lifestyle medicine in the management of skin health. Emerging research around fasting diets, specifically the fasting-mimicking diet (FMD), has provided clinical evidence for chronic inflammatory, cardiometabolic, and autoimmune diseases. In this randomized controlled trial, we evaluated the effects of a five-day FMD protocol, administrated once a month for three months, on facial skin parameters, including skin hydration and skin roughness, in a group of 45 healthy women between the ages of 35 to 60 years old over the course of 71 days. The results of the study revealed that the three consecutive monthly cycles of FMD resulted in a significant percentage increase in skin hydration at day 11 (p = 0.00013) and at day 71 (p = 0.02) relative to baseline. The results also demonstrated maintenance of skin texture in the FMD group compared to an increase in skin roughness in the control group (p = 0.032). In addition to skin biophysical properties, self-reported data also demonstrated significant improvement in components of mental states such as happiness (p = 0.003) and confidence (0.039). Overall, these findings provide evidence for the potential use of FMD in improving skin health and related components of psychological well-being.

Systematic Review of Psychological Interventions for Quality of Life, Mental Health, and Hair Growth in Alopecia Areata and Scarring Alopecia.

Alopecia is associated with significant psychological burden. There is limited evidence on the use of psychological interventions in conditions of hair loss. This manuscript systematically reviews the current state of literature on psychological treatments for quality of life, mental health, and hair growth in various forms of alopecia. PubMed and Embase were searched with predefined inclusion and exclusion criteria. Reference lists were also examined for relevant studies. Nine articles met our criteria and are included in this review. Eight of the articles related to alopecia areata and one related to scarring alopecia. Mindfulness-based stress reduction (MBSR) was found to improve quality of life-related subjective symptoms, relationship impacts, anxiety, phobia, distress, and psychological symptom intensity. Alopecia-specific collocated behavioral health (CLBH) treatment showed a trend for psychosocial improvement in areas such as appearance shame, activity avoidance, negative emotions, and coping. Hypnotherapy was found to improve anxiety and depression, quality of life measures, and alexithymia. There was also some evidence for significant hair growth with hypnosis, but the data are mixed. Psychotherapy combined with immunotherapy led to more hair growth, and supported self-confidence. Finally, coping strategies modulated the subjective burden of alopecia, and were associated with disease improvement. Further research will be necessary to better establish the efficacy and optimal administration of these interventions in alopecia.

The Gut and Skin Microbiome in Alopecia: Associations and Interventions.

Objective: This review examines the current literature on the gut-skin connection in alopecia and summarizes interventions that impact hair growth by modulation of the gut or skin microbiome. Methods: PubMed searches were done to assess studies of the gut and skin microbiome and forms of alopecia including, alopecia areata (AA), androgenic alopecia (AGA), alopecia universalis (AU), central centrifugal cicatricial alopecia (CCCA) and lichen planopilaris (LPP). Filters were applied for human and animal studies. Articles not translated to English and studies assessing supplemental therapies on alopecia were excluded. Results: There is evidence that scalp, hair follicle, and gut microbiome alterations are associated with various types of alopecia. There is potential in the use of interventions targeting microbiome dysbiosis, including fecal transplants and probiotics. Limitations: This field of study still requires more high-quality research and studies with larger participant populations. Conclusion: Dysbiosis on the scalp, within the hair follicle and the gut seem to have a role in the pathophysiology of various forms of alopecia. There is evidence that interventions targeting dysbiosis may have potential in the treatment and management of hair loss. Further studies are needed to establish a direct connection and to clarify specific effects of these interventions.

Effect of Pulsing Digital Heating Devices on Skin Parameters, Subjective Pain, Mood, and Anxiety.

A common pitfall of many conventional heat therapy methods is the propensity to lose heat over time and the need for reheating and reapplication. Pain-relieving digital heating devices are now available that can be held in place on the body via adhesive or magnet and provide pulsed heat. However, the safety of such devices among different ages and skin types must be established. We conducted a prospective, open-label study to assess the effect of three consecutive thirty-minute treatment cycles on skin parameters and pain. Effects on mood and anxiety were secondarily assessed. 22 adult participants (20 female, 2 male; mean 58 ± 17.63 years) were recruited. The participants attended one visit with heating device intervention and a follow-up visit after 7-10 days. A 97% significant increase in transepidermal water loss was observed immediately following intervention (p = 8.04487 × 10-7), although significance was not sustained at follow-up. There was an increase along the red/green axis at 13/14 treatment locations immediately following treatment, although only four locations remained significantly increased at follow-up. Pain non-significantly decreased immediately following treatment (p = 0.057). A 38.6% decrease in subjective anxiety was observed immediately after treatment (p = 0.0139), and scores remained non-significantly reduced at follow-up (19.3% reduction from baseline; p = 0.1397). The heating devices elicit temporary changes to the skin, although the lack of significance at follow-up suggests that the devices can be safely used without long-term changes in skin color or barrier status.

Soy Protein Containing Isoflavones Improves Facial Signs of Photoaging and Skin Hydration in Postmenopausal Women: Results of a Prospective Randomized Double-Blind Controlled Trial.

Preliminary findings from multiple studies indicate that dietary intake of soy-derived isoflavones exert beneficial effects on the skin including defense against oxidant damage, stimulation of collagen synthesis, and increased hydration. This study aims to investigate how oral supplementation of a soy protein isolate with added isoflavones (SPII) affects components of photoaging such as facial wrinkles and dyspigmentation, and skin biophysical measures such as skin hydration and sebum excretion in postmenopausal women. This 6-month prospective, randomized double-blind controlled study was conducted on 44 postmenopausal women with Fitzpatrick skin types I, II, and III who were randomized to receive either casein protein or SPII. A high-resolution facial photography system was used to measure wrinkle severity and pigmentation at 0, 8, 16, and 24 weeks. Skin biophysical measurements included skin hydration and sebum production. The average wrinkle severity was decreased in the SPII intervention group at week 16 and week 24 by 5.9% and 7.1%, respectively, compared to the baseline. Compared to the casein group, average wrinkle severity was significantly decreased at week 16 (p < 0.05) and week 24 (p < 0.0001). Facial pigment intensity was decreased by -2.5% (p < 0.05) at week 24, whereas there was no significant change in the casein group. Compared to baseline, skin hydration in the SPII group was significantly increased by 39% and 68% on the left and right cheeks (p < 0.05), respectively, at 24 weeks. There were no significant differences in sebum production. Dietary soy protein supplementation with isoflavones may improve skin photoaging, including wrinkles and dyspigmentation, and increase skin hydration in postmenopausal women with Fitzpatrick skin types I, II, and III.

Prospective Placebo-Controlled Assessment of Spore-Based Probiotic Supplementation on Sebum Production, Skin Barrier Function, and Acne.

Probiotic supplementation has been shown to modulate the gut-skin axis. The goal of this study was to investigate whether oral spore-based probiotic ingestion modulates the gut microbiome, plasma short-chain fatty acids (SCFAs), and skin biophysical properties. This was a single-blinded, 8-week study (NCT03605108) in which 25 participants, 7 with noncystic acne, were assigned to take placebo capsules for the first 4 weeks, followed by 4 weeks of probiotic supplementation. Blood and stool collection, facial photography, sebum production, transepidermal water loss (TEWL), skin hydration measurements, and acne assessments were performed at baseline, 4, and 8 weeks. Probiotic supplementation resulted in a decreasing trend for the facial sebum excretion rate and increased TEWL overall. Subanalysis of the participants with acne showed improvement in total, noninflammatory, and inflammatory lesion counts, along with improvements in markers of gut permeability. The gut microbiome of the nonacne population had an increase in the relative abundance of Akkermansia, while the subpopulation of those with acne had an increase in the relative abundance of Lachnospiraceae and Ruminococcus gnavus. Probiotic supplementation augmented the circulating acetate/propionate ratio. There is preliminary evidence for the use of spore-based probiotic supplementation to shift the gut microbiome and augment short-chain fatty acids in those with and without acne. Further spore-based supplementation studies in those with noncystic acne are warranted.

Combining Topical and Oral Botanicals for Skin Redness, Pigmentation, Sleep, and Mood: A Randomized Controlled Study.

External and internal stressors have been found to adversely affect skin health and overall wellness. There is growing interest in the use of anti-inflammatory and antioxidant plant-derived ingredients, such as ashwagandha, saffron, l-theanine, and tocopherol, to mitigate the impact of these stressors. In this study, we evaluate the effectiveness of oral and topical products (InnerCalm and SuperCalm, respectively) that contain naturally derived ingredients on skin redness, skin pigmentation, sleep, and mood in healthy females with Fitzpatrick skin type 1−4 and self-perceived sensitive skin. Subjects were randomized to an oral (oral group), a topical (topical group), or a combination of both the oral and topical interventions (combined group). Standardized photography-based image analysis was used to assess skin redness and pigment. Self-assessments of mood and sleep were measured with the abbreviated profile of mood states (POMS) questionnaire, and the Pittsburgh sleep-quality index (PSQI), respectively. Assessments were made at the baseline, 1-week, 4-weeks, and 8-weeks of the intervention. The average facial redness decreased in the topical group at 8-weeks (p < 0.001) and in the combined group at 4-weeks (p < 0.05) and 8-weeks (p < 0.001), relative to the baseline. The average facial pigmentation decreased in the oral (p < 0.05) and combined (p < 0.05) cohorts at 8-weeks, relative to the baseline. The oral group exhibited an improvement in sleep quality at 1-week relative to the baseline (p < 0.05) and at 8-weeks relative to the baseline (p < 0.05). Finally, the combined group demonstrated improvement in fatigue (p < 0.01) and confusion (p < 0.05) at 8-weeks relative to the baseline, though total mood disturbance increased in all 3 groups over the course of the study. Measured outcomes relating to mood may be confounded with the timing of the study, which ran during the COVID pandemic. Overall, we demonstrate the role of oral and topical herbs and of nutraceuticals for skin health and wellness. Further research will be needed to elucidate synergistic effects in oral and topical combination regimens.

Prospective Randomized Controlled Trial on the Effects of Almonds on Facial Wrinkles and Pigmentation.

BACKGROUND: Almonds have long been studied as a rich source of fatty acids, phytochemical polyphenols and antioxidants such as vitamin E. A recent study compared almond supplementations to a calorie-matched intervention for 16 weeks, yielding statistically significant improvement in wrinkle severity in postmenopausal women with Fitzpatrick skin types I and II that received almonds. This study furthers that assessment with a larger population and duration of 24 weeks to assess the influence of almond consumption on wrinkle severity, skin pigmentation and other skin biophysical profiles. OBJECTIVE: To investigate the effects of almond consumption on photoaging such as wrinkles and pigment intensity as well as facial biophysical parameters such as sebum production, skin hydration and water loss. DESIGN AND INTERVENTIONS: A prospective, randomized controlled study assessed postmenopausal women with Fitzpatrick skin types I or II who consumed 20% of their daily energy consumption in either almonds or a calorie-matched snack for 24 weeks. A facial photograph and image analysis system was used to obtain standardized high-resolution photographs and information on wrinkle width and severity at 0, 8, 16 and 24 weeks. Measurements of transepidermal water loss (TEWL), skin pigmentation, skin hydration and sebum production were also completed at each visit. RESULTS: The average wrinkle severity was significantly decreased in the almond intervention group at week 16 and week 24 compared to baseline by 15% and 16%, respectively. Facial pigment intensity was decreased 20% in the almond group at week 16 and this was maintained by week 24. There were no significant differences in skin hydration or TEWL in the almond group compared to the control, although sebum excretion was increased in the control group. CONCLUSION: The daily consumption of almonds may improve several aspects of photoaging such as facial wrinkles and pigment intensity in postmenopausal women. In conclusion, the daily consumption of almonds may contribute to the improvement of facial wrinkles and reduction of skin pigmentation among postmenopausal women with Fitzpatrick skin types I and II.