BackgroundFacial skin has an essential cosmetic function in both men and women, and photoaged skin can affect the quality of life in healthy people. Ashwagandha (Withania somnifera) which is also called Indian ginseng has adaptogenic properties and is used in traditional Indian medicine to maintain balance, energize, and rejuvenate. ObjectiveThis randomized, double-blind, and placebo-controlled study assessed the efficacy and safety of topical application of lotion containing 8% standardized Ashwagandha root extract on improvement of skin parameters in the photoaged facial skin of healthy subjects. MethodsFifty-six healthy men and women aged between 18 and 60 years with Fitzpatrick phototype III-VI skin grade were randomized to receive the topical application (lotion on facial skin) of either Ashwagandha 8% (AG, n=28), or an identical placebo (PL, n=28) for 60 days. The primary outcome was the change from baseline on day 60 in the scores for global physician assessment scoring for the five dermatological signs (skin wrinkles, pores, hydration/moisture, skin brightness/tone, and pigmentation) on facial skin. Secondary outcomes were changes from baseline in the transepidermal water loss (TEWL), melanin index, hydration, and skin elasticity (R2 ratio). Another efficacy outcome was quality of life using the health-specific Short Form Health Survey-12 (SF-12). Safety was assessed using local reactions and adverse events. Three (1 AG, 2 PL) patients were lost to follow-up and per-protocol (PP) data included 53 patients (27 AG, 26 PL). For measurement data, repeated measures analysis of variance (ANOVA) was used to assess treatment effect at different time periods in the PP dataset (n=53). Two groups were compared for differences using a t-test for continuous data or a Mann-Whitney 'U' test for ordinal data. Adverse events were compared between two groups using the chi-square test. ResultsGreater reduction (p<0.0001) in total physician assessment scores from baseline to day 60 was observed with AG (-74.69%) compared to PL (-48.68%). There was a greater improvement in TEWL, skin hydration, and skin elasticity (R2 ratio) with AG as compared to placebo (p<0.0001). However, the change in melanin index was similar in the two groups at the end of day 60 (p=0.969). The percentage increase in melanin index from baseline to day 60 in the PP dataset was by -2.82% with AG and -1.78% with PL, whereas the percentage reduction in TEWL from baseline to day 60 in the PP dataset was by -15.12% with AG and -8.34% with PL. Similarly, greater percentage improvements were seen with AG as compared to PL for skin hydration (20.66% with AG and 9.5% with PL) and elasticity was assessed by the R2 ratio (16.34% with AG and 3.73% with PL). Adverse events were comparable in the two groups. ConclusionsTopical application of a lotion containing Ashwagandha standardized root extract improves the skin condition and quality of life in photoaged healthy individuals. Further studies with different skin types and standard comparators are warranted to subst...