A randomized, double blind, placebo-controlled trial
allergic, atopic dermatitisbe, skin disorders, skin diseasehave current skin diseases
SKIN DISEASE, SKIN, BLIND, SKIN DISORDERS
Sixty healthy women aged 40 to 60 years were recruited in the clinical trial.The inclusion criteria were shown as follows.be able to inform consentbe able to follow the instruction of the research strictlybe 40—60 years oldbe a womanbe healthy without any congenital skin disease.The exclusion criteria were shown as follows.be not able to inform consentbe not able to follow the instruction of the research strictlyhave a congenital skin diseasehave current skin diseases such as atopic dermatitisbe allergic to substancesbe in a special treatment for any diseasehave tattoos or wounds or skin disorders at the tested skin areabe a volunteer in other clinical research.The Human Ethics Committee of the Faculty of Pharmacy, Chiang Mai University, Thailand approved the trial protocol (Protocol no. 41/2020) and all participants provided written, informed consent. The trial protocol was registered toward Thai Clinical Trials Registry (TCTR) on 17/01/2023 with a clinical trial registration number of TCTR20230117007. The methods for the randomized, double blind, placebo-controlled trial was carried out in accordance with the standard procedures of the Thai Guideline for Good Clinical Practice corresponding to ICH-GCP. The overall process is shown in Fig. Overall process of the clinical study.Skin hydration was measured by Corneometer® CM825 (Courage and Khazaka Electronic GmbH, Cologne, Germany) and expressed in arbitrary units indicating the electrostatic capacity, proportional to the moisture content in the stratum corneumSkin elasticity was measured by Cutometer® Dual MPA 580 (Courage and Khazaka Electronic GmbH, Cologne, Germany) that rendered a negative pressure of 450 mbar for 2 s and off pressure for 2 s in triplicates. The parameter of USkin wrinkles were evaluated in terms of surface, volume, Ra, and Rz implying the amount of wavy surface compared with stretched areas, the virtual amount of liquid needed to fill in the skin furrow, the height of the skin furrow, and the arithmetic average of the skin roughness, respectively. Skin Visiometer® SV 700 (Courage and Khazaka Electronic GmbH; Cologne, Germany) was employed to directly visualize and analyze the skin wrinkles.