Clinical Trials

S.NO Title Abstract Full Study

Clinical Evaluation of a Nature-Based Bakuchiol Anti-Aging Moisturizer for Sensitive Skin

Background:Patients with sensitive skin find topical retinoid use for anti-aging purposes challenging due to irritation. Bakuchiol, a meroterpene from the Psoralea corylifolia seed, has retinol functionality through retinol-like regulation of gene expression.

Objective:This research examined the tolerability, efficacy, and barrier effects of a nature-based bakuchiol-containing cleanser and moisturizer in subjects with sensitive skin.

Methods:60 female subjects Fitzpatrick skin types I–V age 40–65 years with sensitive mild to moderate photodamaged skin were enrolled in this 4 week study. A sensitive skin panel was constructed: 1/3 eczema/atopic dermatitis, 1/3 rosacea, 1/3 cosmetic intolerance syndrome. Subjects used a nature-based cleanser and moisturizer twice daily and underwent transepidermal water loss (TEWL), corneometry, tolerability assessments, and efficacy assessments at baseline, 5–10 minutes post-application, and week 4.

Results:The skin care products were well tolerated and efficacious (P<0.001) in terms of investigator assessed improvement in visual smoothness, tactile smoothness, clarity, radiance, overall appearance, and global anti-aging. Cheek corneometry measurements demonstrated a statistically significant 16% increase in skin moisture content (P<0.001).

Conclusion:A bakuchiol nature-based anti-aging moisturizer is well tolerated and effective in individuals with sensitive skin.J Drugs Dermatol. 2020;19(12): doi:10.36849/JDD.2020.5522.

Epidermal and Dermal Hallmarks of Photoaging are Prevented by Treatment with Night Serum Containing Melatonin, Bakuchiol, and Ascorbyl Tetraisopalmitate: In Vitro and Ex Vivo Studies

Introduction:Photoaging is a complex process that is chiefly the result of oxidative stress caused by ultraviolet (UV)-generated reactive oxygen species.To counter this process, we developed a 3-in-1 night facial serum (3-in-1 NFS) containing a combination of direct and indirect antioxidants and polyphenols that is designed to attenuate UV-generated free radicals and stimulate dermal protein synthesis. In clinical trials 3-in-1 NFS improved the appearance of photoaged skin. In this study we sought to identify some of the main histologic changes responsible for this.

Methods:We performed an immunolabeling analysis of some of the salient epidermal and dermal proteins in 3-in-1 NFS-treated primary epidermal keratinocytes (HEKs) and dermal fibroblasts (HDFs) in vitro, and in UV-exposed skin explants ex vivo. Numbers of apoptotic sunburn cells following exposure of 3-in-1 NFS-treated skin explants to UV radiation were also determined.

Results:We demonstrate that 3-in-1 NFS increases levels of filaggrin and aquaporin 3 in HEKs, and levels of collagen I and collagen III in HDFs in vitro. Levels of precursor procollagen type I and tropoelastin were increased in ex vivo skin explants. Numbers of apoptotic sunburn cells were significantly reduced in UV-exposed skin explants. These effects were only observed with the combination of ingredients in 3-in-1 NFS, suggesting that they have a synergistic effect on photoaged skin biology.

Conclusion:Our results show that some of the histological hallmarks of photoaging are improved with the use of 3-in-1 NFS.

Keywords:Antioxidant; Ascorbyl tetraisopalmitate; Bakuchiol; Melatonin;Photoaging; Polyphenol; Skin aging; Ultraviolet.

Prospective, randomized,double-blind assessment of topical bakuchiol and retinol for facial photoageing

Background:Bakuchiol is a phytochemical that has demonstrated cutaneous antiageing effects when applied topically. Early studies have suggested that bakuchiol is a functional analogue of topical retinoids, as both compounds have been shown to induce similar gene expression in the skin and lead to improvement of cutaneous photodamage. No in vivo studies have compared the two compounds for efficacy and side-effects.

Objectives:To compare the clinical efficacy and side-effect profiles of bakuchiol and retinol in improving common signs of cutaneous facial ageing.

Methods:This was a randomized, double-blind, 12-week study in which 44 patients were asked to apply either bakuchiol 0·5% cream twice daily or retinol 0·5% cream daily. A facial photograph and analytical system was used to obtain and analyse high-resolution photographs of patients at 0, 4, 8 and 12 weeks. Patients also completed tolerability assessment questions to review side-effects. During study visits, a board-certified dermatologist, blinded to study group assignments, graded pigmentation and redness.

Results:Bakuchiol and retinol both significantly decreased wrinkle surface area and hyperpigmentation, with no statistical difference between the compounds.The retinol users reported more facial skin scaling and stinging.

Conclusions:Our study demonstrates that bakuchiol is comparable with retinol in its ability to improve photoageing and is better tolerated than retinol.Bakuchiol is promising as a more tolerable alternative to retinol.

https://onlinelibrary.wiley.c om/doi/full/10.1111/bjd.16 918

A dermocosmetic containing bakuchiol,Ginkgo biloba extract and mannitol improves the efficacy of adapalene in patients with acne vulgaris: result from a controlled randomized trial

Background: Acne vulgaris is an inflammatory disorder of the pilosebaceous unit.

Aim: To confirm that BGM (bakuchiol, Ginkgo biloba extract, and mannitol)complex increases the established clinical efficacy of adapalene 0.1% gel in patients with acne.

Methods: A clinical trial was conducted in acne patients. A total of 111 subjects received adapalene 0.1% gel and BGM complex or vehicle cream for 2 months. Assessments comprised Investigator Global Assessment (IGA), global efficacy, seborrhea intensity, inflammatory and non-inflammatory lesions, and subject perception, as well as overall safety and local tolerance and quality of life.

Results: At the end of the trial, inflammatory and non-inflammatory lesions, IGA, global efficacy, and seborrhea intensity had significantly improved in both treatment groups. Differences were statistically significant (P<0.05) in favor of BGM complex for inflammatory lesions as well as IGA and seborrhea intensity.Global efficacy assessments and subject perception confirmed the superiority of BGM complex-including treatment over the comparative combination. Quality of life had improved more with the active combination than with the vehicle combination. In the active group, four subjects had to interrupt temporarily BGM complex and 12 adapalene compared to seven subjects interrupting the vehicle and eleven adapalene in the vehicle group. One subject withdrew from the trial due to an allergy to adapalene. The majority of all events were mild.

Conclusion: BGM complex improves the treatment outcome of adapalene 0.1% gel in patients with acne vulgaris. Overall, safety and local tolerance of BGM complex were good.

Keywords: BGM complex; P. acnes; acne vulgaris; adapalene; bakuchiol;sebum.

An Open Label Clinical Trial to Evaluate the Efficacy and Tolerance of a Retinol and Vitamin C Facial Regimen in Women With Mild-to-Moderate Hyperpigmentation and Photodamaged Facial Skin

A 12 – week open label, single centre clinical usage trial was conducted to determine the effectiveness of aa dual product regimen consisting of a 0.5% retinol treatment and an anti-aging moisturizer with 30% vitamin C in women with mild to moderate hyperpigmented questionnaires, and digital photography were completed at baseline and at weeks 4, 8 and 12. A total of 44 women completed the study. Effective ingredients incorporated into the 0.5% retinol treatment included encapsulated retinol for a retinol concentration of 0.5%,bakuchiol and Ophiopogon japonicus root extract. The anti-aging moisturizer with 30% vitamin C contained 30% vitamin C in the form tetrahexyldecyl ascorbate (THD ascorbate), alpha-tocopheryl acetate (vitamin E) and ubi-quinone (coenzyme Q10). The facial regimen produced a statistically significant decrease (improvement) in clinical grading scores for all parameters assessed at weeks 8 and 12 when compared with baseline scores. In addition, the majority of these parameters were improved at wee 4. The test regimen was well – perceived by the subjects for various regarding facial skin condition, product efficacy, and product attributes. Several tolerability parameters were assessed with no statistically significant increase except for dryness. A statistically significant increase in clinical grading scores for dryness on the face occurred at weeks 4 and 8 when compared to baseline scores. The increase in dryness is expected when introducing a retinol to a facial regimen and the dryness did not persist to the week 12 time point.