A Single-center, Double-blinded, Randomized, Placebo-controlled Trial Evaluating the Safety and Efficacy of a Dietary Supplement Containing Rosemary Extract on Visible Facial Skin Quality

J Clin Aesthet Dermatol. 2025;18(3):28–33.

by Zoe Diana Draelos, MD, FAAD; Audrey Gueniche, PharmD, PhD; Margarita Yatskayer, MS; and Diane B. Nelson, RN, MPH

Dr. Draelos is with Dermatology Consulting Services, PLLC, in High Point, North Carolina. Dr. Gueniche is with L’Oréal Research and Innovation, Development in Chevilly Larue, France. Ms. Yatskayer is with L’Oréal Research and Innovation, Evaluation Intelligence, in Clark, New Jersey. Ms. Nelson is with skinbetter science, a Dermatological Beauty brand of L’Oréal USA Inc. in Phoenix, Arizona. 

FUNDING: This study was funded by L’Oréal Research and Innovation.

DISCLOSURES: Dr. Draelos is a researcher and consultant for skinbetter science, Inc. Dr. Gueniche and Ms. Yatskayer are employees of L’Oreal. Ms. Nelson is an employee of skinbetter science, Inc., a subsidiary company of L’Oreal.

ABSTRACT: Objective: Glycative stress promotes the accumulation of advanced glycation end products (AGEs), impairing extracellular matrix proteins and accelerating skin aging. Rosemary extract has been shown to deglycate AGE crosslink proteins. The safety of a dietary supplement containing rosemary extract (BioR) and its efficacy on skin quality parameters was evaluated over 12 weeks. Methods: The randomized, double-blinded, placebo-controlled trial included female participants, aged 40 to 65 years, with moderate-to-severe skin dullness and roughness/texture, and mild-to-moderate erythema, pore size, and uneven pigmentation based on a six-point grading scale. Subjects were randomized to either BioR (n=52) or placebo ([PLB] n=52). The dosing schedule was as follows: from Weeks 1 to 4, two capsules three times daily; from Weeks 5 to 8, two capsules twice daily; from Weeks 9 to 12, one capsule twice daily. Capsules were taken with food. Investigator assessments occurred at baseline and Weeks 4, 8, and 12. Global skin quality (total sum of scores) and adverse events (AEs) were recorded over 12 weeks. Results: Mean age, severity and baseline demographics of subjects were similar across groups. Significant mean improvements in BioR versus PLB were observed in skin dullness (p=0.04), roughness/texture (p=0.001), erythema (p=0.05) and pore size (p=0.04) at Week 12. No significant differences occurred in uneven pigmentation. Significant mean improvements in global skin quality were demonstrated in BioR versus PLB at Weeks 8 (p<0.0001) and 12 (p=0.002). One subject (BioR) discontinued at Week 4 due to possibly related, moderate gastrointestinal upset. Conclusion: Following 12 weeks of use, a dietary supplement containing rosemary extract and its natural cofactors led to significant mean visible improvements compared to placebo in skin dullness, roughness/texture, erythema, and pore size, and was well tolerated.

Keywords: Glycation, advanced glycation end products, AGEs, rosemary extract, nutraceutical, dietary supplement, skin quality

Introduction

Facial skin quality is a visible reflection of what is occurring inside the body as well as the effects of external exposures, and while the appearance of skin may not provide a complete picture, the texture, color, and firmness of one’s skin can indicate changes in health status or condition. Cumulative exposure to extrinsic factors, such as ultraviolet (UV) radiation and pollution, damage skin, contributing to structural and physiological changes that accelerate skin aging, while intrinsic factors also impact global skin health and facial skin quality. The natural process of aging affects skin at the cellular level, resulting in increased mitochondrial production of reactive oxygen species (ROS) as well as cellular senescence. Often associated with age- and disease-related conditions, such as diabetes, glycation and the accumulation of advanced glycation end products (AGEs) also substantially impact the structure and physiological functions of the skin.^1–3 

Glycation is a spontaneous, non-enzymatic reaction that occurs in the body between sugars, proteins, DNA, and lipids. Likely beginning early in life, glycation becomes well established by age 30 and beyond.⁴ Glycation leads to the formation of AGEs, harmful byproducts that generate molecular crosslinks between proteins, modifying and impairing their physical properties and functionality.^1–3,5 AGEs have been shown to contribute to age-related diseases and degenerative processes such as Alzheimer’s disease, metabolic diseases such as diabetes and atherosclerosis, and renal failure.^2,6,7 Glycative stress in the body promotes the accumulation of AGEs, accelerating damage to proteins and tissues and degenerative changes associated with aging. Glycative stress also leads to the deposition of AGEs within the dermis, impairing extracellular matrix (ECM) proteins. More than 20 species of AGEs have been identified in human skin, each having different effects on skin and tissue remodeling.^1,2 AGE accumulation in the skin is amplified by exogenous factors such as UV exposure,⁴ with the production of ROS accelerating AGE formation. 

AGE formation leads to the development of intra- and inter-molecular crosslinks between proteins, and particularly ECM proteins, impeding their functionality.³ AGEs primarily accumulate in ECM proteins with slow turnover rates such as collagen which has a long half-life.^8,9 When collagen is glycated, it causes crosslinking with adjacent collagen fibers that disrupts the body’s ability to remodel and repair the collagen fibers, while also changing and weakening the biomechanical properties of collagen leading to an overall reduction in skin elasticity, increased stiffness, and loss of flexibility.^1,10,11 In the epidermis, AGEs have been associated with delayed wound healing, reductions in ceramides, cholesterol, and lipids, increased production of melanin in melanocytes, and destruction of the keratinocyte cell structure.^8,12 

The accumulation of AGEs has been associated with clinical manifestations of skin aging—including the appearance of fine lines and wrinkles, dullness and sallowness, and skin laxity.¹³ As such, minimizing glycative stress and preventing the accumulation of AGEs is one method for facilitating healthier skin and improving skin quality—both visibly and physiologically.^1,7 In addition to lifestyle interventions, the use of topical and dietary compounds rich in phytonutrients, such as carotenoids, flavonoids, and polyphenols, all of which have different antioxidant and anti-inflammatory properties, have demonstrated benefits in inhibiting AGE accumulation.^14,15 Plant-derived phenolic compounds have numerous capabilities, including potent antioxidant, wound healing, anti-pruritic, antifungal and antibacterial effects, and have been utilized to treat skin conditions such as acne, eczema, and rosacea.¹⁶

Belonging to the botanical Lamiaceae family that includes thyme, lemon balm, and sage, rosemary leaf (Rosmarinus officinalis) is a rich source of phenolic diterpenes, flavonoids, and phenolic acids. The rosemary leaf is comprised of powerful antioxidant compounds, or cofactors, including rosmarinic, caffeic, chlorogenic, ferulic, and carnosic acids. Caffeic acid and its derivative, rosmarinic acid (RA), are potent, synergistic, natural bioactive cofactors of the rosemary leaf. In addition to its antioxidant properties, rosemary leaf has anti-inflammatory, antibacterial, and antiviral effects, and has been shown to stimulate circulation.¹⁶ As a raw material, dried rosemary remains stable for extended periods of time and demonstrates consistency of composition across batches. 

An in vitro study evaluating lemon balm leaf (Melissa officinalis) extract, in which RA is a major active component, demonstrated inhibition of the AGE, pentosidine, and suppressed ribose-induced AGE levels of collagen and elastin fibers.¹⁵ In a follow-up open-label study, daily consumption of lemon balm extract in tea for six weeks led to reduced yellowing (sallowness) in the forearm skin of subjects, along with improved cheek skin elasticity, assessed via bioinstrumentation. A separate study reported that ingesting a commercially available powder mixture of dried rosemary leaves with grapefruit (Citrus paradisi) extract led to a reduction in UV-induced facial erythema and lipo-peroxides, and improvement in facial elasticity and wrinkles.¹⁷

Previous studies have investigated the antioxidant and anti-glycation effects of the rosemary leaf^18,19 and have demonstrated the ability of RA to deglycate AGE crosslink proteins.^3,20–22 Utilizing high performance liquid chromatography (HPLC), an in vitro study by Jean et al³ measured the crosslinking rate of glycated albumin (albumin in ribose solution). The crosslink breaking ability of RA and other known anti-glycation agents including aminoguanidine, carnosine, and Alagebrium (ALT-711) were evaluated. Compared to control, RA demonstrated the greatest ability to reverse AGE crosslink proteins (53%, p<0.0001), with ALT-711 (46%, p<0.0001) showing significant benefit as well.³ An additional in vitro study demonstrated that cofactors (CORExtract^TM) found in the rosemary leaf have a deglycation effect. Specifically, rosemary extract and its natural cofactors demonstrated two times more deglycation ability than pure RA alone.²²

An open-label pilot study (unpublished data, 2024) evaluated the use of a dietary skin health supplement containing CORExtract in 30 subjects in generally good health.²³ Subjects consumed three capsules twice daily for the first four weeks, two capsules twice daily for Weeks 5 to 8, one capsule twice daily for Weeks 9 to 12 (with meals). Investigator visible assessments of facial skin quality parameters from baseline included the condition, presence and intensity of fine lines/wrinkles, erythema, dyschromia (pigmentation) and rough/uneven skin texture based on a five-point grading scale. Improvement from baseline in facial skin quality occurred at Week 12 (p<0.0001). Additionally, a 12-percent increase in facial skin elasticity was demonstrated (p=0.001) with a 13-percent decrease in retraction time (p=0.01) from baseline at Week 12. Subjects reported skin was more even-looking, radiant, softer, and healthier looking, with improved skin tone and a less dull-looking complexion from baseline after 12 weeks. In the first four weeks of the study (three capsules twice daily), mild, possibly related gastrointestinal upset occurred in four subjects, with two subjects discontinuing the study.

CORExtract is comprised of a molecular fraction of RA and other synergistic cofactors of the rosemary leaf. The proprietary, multi-sequencing extraction process preserves and optimizes the natural bioactive cofactors in the rosemary leaf. Through this precise, bioguided extraction process, fractions of the rosemary leaf extract are screened to identify biologically active compounds, which are then isolated and purified into a powder extract.

Herein, we describe evaluation of the safety and efficacy of a dietary supplement comprised of CORExtract (BioR; skinbetter science, Inc., Phoenix, Arizona), and its visible effect on facial skin quality compared to placebo.

Methods 

A single-center, double-blinded, randomized, placebo-controlled trial was conducted between January and April 2024 under Independent Review Board (Allendale Investigational Review Board, Old Lyme, Connecticut) approval in conjunction with current Good Clinical Practices (cGCP) guidelines. All subjects enrolled provided consent (via written statement) to participate in the study and the photographic release of their images for research, publication and commercial purposes. The primary efficacy objectives of the study included investigator evaluation of facial skin parameters including skin dullness, skin roughness/texture (visual), erythema, uneven pigmentation and pore size from baseline over 12 weeks utilizing six-point grading scales (0=None to 5=Very Severe). Secondary objectives included quantification of changes in global skin quality utilizing our Global Skin Quality Index (GSQI), subject satisfaction based on a self-assessment questionnaire, and evaluation of safety and tolerability over 12 weeks. Additionally, histological changes in markers associated with glycative stress and AGEs from skin biopsies and tape strips samples were evaluated in a subset of subjects.

The trial enrolled an equal number of peri- and post-menopausal subjects aged 40 to 65 years with moderate (3) to severe (4) skin dullness and roughness/texture, and mild (2) to moderate (3) erythema, pore size, and uneven pigmentation based on a six-point grading scale (0=None to 5=Very Severe). Subjects were eligible to participate if they were nonsmokers, in generally good medical health, on a stable diet, willing to avoid changes in dietary and exercise habits, not using weight loss medications or on a weight loss program, and able to provide informed consent. Subjects committed to not introduce any new dietary or nutritional supplements (including capsule, tablet, pill, powder, liquid or tea forms). Subjects were willing to refrain from introducing any new prescription or non-prescription skincare products, cosmetics and makeup, or undergo any kind of facial procedures including but not limited to botulinum toxin or dermal filler injections, laser resurfacing, radio frequency, microneedling, microdermabrasion, dermaplaning, and facials during the study period. Subjects were required to minimize their UV exposure and use facial sunscreen every day. 

Exclusion criteria included known allergies to rosemary, rosmarinic acid, or any components of the active study product, any dermatologic disorder that could interfere with accurate evaluation of the subject’s facial skin, such as severe acne vulgaris, severe rosacea, seborrheic dermatitis, psoriasis, atopic dermatitis. Eligible subjects could not have a diagnosis of type I or type II diabetes or be using medications to control diabetes or obesity. Subjects with a history of gastrointestinal reflux disorder, Barrett’s Syndrome, or any autoimmune or chronic illness, or a hypo- or hyper-glycemic event in the previous 30 days leading to a visit to an emergency department also led to subject exclusion. Subjects were excluded if they had any previous use of an oral rosmarinic product, used a multivitamin or single, separate or individual oral, dietary or nutritional supplements or herbal teas including vitamin C, E, B derivatives, nicotinamide, niacinamide, zinc, biotin, manganese, carnosine, green tea, lemon balm leaf or rosemary extract within the prior four weeks. Subjects who were currently using vitamin D were allowed to continue use without changing either the dosage or the brand. Subjects were excluded if they used topical alpha hydroxy acids, beta hydroxy acids, antioxidants, vitamin C-based products, peptides or growth factors, prescription or non-prescription topical retinoids, or prescription strength hydroquinone in the prior four weeks. Subjects that have used or were using any skincare product or underwent any procedure which, in the Investigator’s opinion, may have interfered with the study evaluation were also excluded from participation. 

Based on computerized randomization, eligible subjects were randomized to active study product, BioR (n=52), or Placebo (PLB [glyceryl dibehenate, vegetable capsules], n=52). BioR capsules were comprised of rosemary extract and its natural cofactors (300mg/capsule), biotin (2mcg), zinc (zinc gluconate, 0.45mg), and glyceryl dibehenate in vegetable capsules. BioR and PLB capsules were provided in the same, opaque, white bottles that included the number of capsules, usage instructions, and a lot number on the label. Different lot numbers were used to identify the BioR and PLB capsules. An unblinded study coordinator was assigned to count and dispense capsules at each study visit. The study investigator and all other study personnel were blinded to treatment group throughout the course of the study. A mineral sunscreen was provided to all subjects for daily use, no other topical products were provided.

Subjects were instructed to take the capsules with a meal for 12 weeks. Subjects were instructed to take two capsules three times daily (breakfast, lunch and dinner) for Weeks 1 to 4, two capsules twice daily (breakfast and dinner) for Weeks 5 to 8, and one capsule twice daily (breakfast and dinner) for Weeks 9 to 12 (Figure 1).

Investigator evaluation of erythema, pores, skin dullness, skin roughness/texture (visual), and uneven pigmentation occurred at baseline, 4, 8, and 12 Weeks using a six-point grading scale (0=None to 5=Very Severe). Global skin quality was calculated for each subject using our Global Skin Quality Index (GSQI), which is based upon the total sum of scores according to investigator grading of the individual parameters (erythema, pore size, skin dullness, skin roughness/texture [visual], and uneven pigmentation). 

Skin biopsies of the volar surface of the left upper arm and tape strip tissue samples of the stratum corneum of the right, volar surface of the forearm were obtained in a subset of 32 subjects (BioR, n=16; PLB, n=16) at baseline and Week 12. Analysis of skin tissue samples included the evaluation of markers associated with glycative stress and AGEs. These results are reported separately.²⁴

Subjects completed a self-assessment questionnaire at Weeks 4, 8, and 12. Collection and evaluation of adverse events (AEs) occurred throughout the study.

Results

One hundred and four (N=104) women with Fitzpatrick Skin Type (FST) I to VI were enrolled and 100 subjects completed the study. Subject age and baseline demographics were similar across the two treatment groups (Table 1), and peri- and post-menopausal women were equally distributed between the groups. Four subjects discontinued the study, two from each treatment group. In the BioR treatment group, one subject discontinued in the first few weeks of the study owing to moderate, possibly related gastrointestinal upset and one subject discontinued due to a personal matter. In the PLB treatment group, one subject discontinued after Week 8 and one subject was lost to follow-up.

Efficacy. Significant mean percent reductions were observed in the BioR treatment group versus the PLB treatment group at Week 8 in skin dullness (–23%, p=0.0007), roughness/texture (–26%, p<0.0001), and erythema (–12%, p=0.03). Significant mean percent reductions in the BioR treatment group versus the PLB treatment group were observed at Week 12 in skin dullness (–28%, p=0.04), roughness/texture (–30%, p=0.001), erythema (–14%, p=0.05) and pore size (–2%, p=0.04) (Figure 2). There were no significant differences observed between treatment groups in uneven pigmentation. Significant mean improvements in global skin quality were demonstrated in the BioR treatment group versus the PLB treatment group at Week 8 (14%, p<0.0001) and 12 (17%, p=0.002) (Figure 3, Figure 4A–D).

Tolerability. Possibly related AEs reported in the BioR treatment group included one case of moderate gastrointestinal upset that occurred in the first few weeks and led to study discontinuation. Mild, possibly related events (n=5) included reports of stomach upset, bloating, acid reflux, and indigestion. All events were transient and resolved without sequalae. 

Subject satisfaction. A higher percentage of subjects in the BioR treatment group versus the PLB treatment group agreed that their facial skin looked brighter, firmer, smoother, more youthful, more even looking, and less dull, yellow, or red looking at 12 weeks. In comparison, subject satisfaction in the PLB treatment group appeared to plateau around Week 8.

Discussion

Skin aging is a complex, multifactorial process affected by both intrinsic aging and extrinsic factors, including chronic exposure to UV, pollution, and cigarette smoking. At a molecular level, glycation leads to structural changes in the skin. The accumulation of AGEs stimulates inflammation and oxidative stress and increases melanogenesis, causing greater damage to the skin manifesting in the appearance of fine lines and wrinkles, reduced elasticity, and skin dulling and yellowing.^11,25

Although several molecules are known to inhibit the glycation process leading to a slow reduction of glycated proteins, this primarily occurs in proteins with medium or fast turnover rates. Inhibition is far less efficient on slow turnover proteins like collagen. Discovering safe molecules that have the ability to disrupt established AGE crosslink proteins is a major advancement in improving glycated skin.²⁰ Rosemary extract is a potent antioxidant rich in phenolic compounds, including RA.^16,26 Plants containing RA are numerous, but use is limited based on optimal and safe dosages, raw material availability, extraction and manufacturing challenges. In vitro studies performed evaluating RA and CORExtract demonstrated the ability to deglycate AGE crosslink proteins.^3,18,19,21 The formulation evaluated in this study was developed using a precise, multi-sequencing extraction process that preserves and optimizes the natural bioactive cofactors of the rosemary leaf including RA. 

Significant, progressive reductions were demonstrated in skin dullness, roughness/texture, erythema, and pore size, with improvements in global skin quality occurring in the BioR treatment group versus the PLB treatment group at 12 weeks. BioR was well tolerated with only one subject discontinuing owing to moderate gastrointestinal upset that occurred in the first few weeks of the study in which a higher number of capsules were required.

Consistent education and reinforcement of dosage instructions employed by the study investigator and staff in the form of simple, clear written instructions, text reminders and video instruction over the course of the study resulted in high mean rates of adherence to the dosing regimen (87%, Weeks 1–4; 94%, Weeks 5–8; 100%, Weeks 9–12). This was also evident in the low drop-out rates occurring in this study. In contrast, reported adherence rates for subjects taking chronic medications are approximately 50 percent.^27,28 Recent studies conducted on nutraceutical products requiring subjects take multiple capsules daily have not previously reported rates of subject compliance or protocol adherence.^29,30

Clinical trials conducted with dietary supplements often require more time in order to visibly observe changes, hence, 12 weeks may not have been sufficient to fully elucidate the benefits of this formula. Although a placebo effect was observed in this study, this frequently occurs in randomized, placebo-controlled studies, with some studies reporting up to nearly half of the overall treatment effect potentially attributable to placebo effects.³¹ Future studies evaluating effects over longer treatment periods, including a more diverse population, and different dosing regimens are warranted. 

Conclusion

A dietary supplement containing rosemary extract and its natural cofactors led to significant mean reductions in skin dullness, roughness/texture, erythema and pore size versus placebo at 12 weeks. The dietary supplement was well tolerated, with six possibly related, transient gastrointestinal adverse events reported, all resolving without sequalae.

Acknowledgements 

We would like to thank Lynne Kolton Schneider, PhD, for her editorial assistance on this manuscript.

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