Background The efficacy of adipose-derived mesenchymal stem cells (ADMSCs) secretome for skin aging has been established, yet no studies hitherto directly investigated the best administration method for such purpose. Purpose We aimed to compare microneedling (MN) versus fractional CO 2 laser (FL) as methods of delivery for ADMSCs secretome in the treatment of aging skin. Patients and Methods A single-blind, randomized split-face clinical trial was conducted on 30 Indonesian women (aged 35–59 years old) with signs of facial cutaneous senescence. Their initial aging status was assessed by dermoscopy photoaging scale (DPAS) and Janus-III measurement system. In the second and fourth weeks, all participants were treated with both MN and FL, followed by the application of a four-fold concentrated ADMSC secretome. The assignment of which side of the face received MN or FL was done by computer-based randomization. Skin parameters were reevaluated on the fourth and sixth weeks, along with patient satisfaction, level of comfort, preference for administration techniques, and also adverse events experienced during the study. Appropriate statistical analyses were subsequently performed at a significance level of 0.05. Results Significant improvements in total DPAS and wrinkles were found in the MN and FL groups at the end of the trial. In contrast, no statistical differences in all parameters were observed between groups in the fourth and sixth weeks. FL scored higher than MN for satisfaction and preference, but lower in terms of comfort. Pain, burning sensation, and itch were the side effects experienced by subjects upon treatment. Two patients had prolonged reddish skin succeeding FL treatment, which relieved with moisturizer application. Conclusion Both MN and FL yielded comparable results for improving several skin aging features. However, subjective preference for ADMSCs secretome administration method may differ when considering satisfaction, comfort, and possible adverse events.

BACKGROUND Outdoor swimming athletes are exposed to undesirable environmental conditions, such as long-term sun exposure. The risk of sunburn can still occur in this population due to the loss of sunscreen and an increase in the sensitivity of the skin to UV rays, particularly UVB, in wet conditions. There are two types of sunscreens based on the filter component, specifically organic and inorganic. Some previous trials showed that organic sunscreens had a longer shelf-life than inorganic after exercise due to their characteristics to bind better with the skin layer. Meanwhile, inorganic sunscreens tend to form layers on their skin’s surface so that they can be more easily removed. To our knowledge, no studies evaluate sunscreens' resistance, either inorganic or organic, after exercising in Indonesia. OBJECTIVE We will conduct a randomized, split-body, double-blind, noninferiority, and multicenter clinical trial to evaluate the persistence of the inorganic versus organic sunscreens in swimmers. The primary objective is to assess whether inorganic sunscreen is as good as organic sunscreen in the field of the persistence of sunscreens after swimming for 1,5 hours. METHODS Research subjects will be randomly selected from one swimming center in Cikini, Jakarta, Indonesia. An estimated 22 athletes in each group will be randomized using a computer-generated randomization method. We calculated the sample size using the difference in the average decrease in SPF levels that is considered significant based on the clinical judgment set by the researchers, which was 5. Neither the research subjects nor the researchers are aware of the type of sunscreen that was applied. RESULTS This study will test all procedures in preparation for conducting the main study, including several potential obstacles and challenges from the perspective of participating physicians and eligible swimmers. This study has been approved by the Ethical Committee Faculty of Medicine Universitas Indonesia and is funded by the International Publication Grant from Universitas Indonesia. Study results will be disseminated through publications in a peer-reviewed journal with Open Access format. This study will provide information about SPF 30 persistence in sunscreens and the best type of sunscreen to be used while swimming, particularly for athletes. CONCLUSIONS We expect the results of this study can be concluded as follows: 1. Decreasing number in the SPF level of inorganic and organic sunscreens after use swimming 1.5 hours. 2. The SPF resistance of inorganic sunscreens is better than sunscreen organic after being used to swim for 1.5 hours CLINICALTRIAL This clinical trial has been registered into ClinicalTrials.gov with identifier NCT04618536 and Ethical Committee Faculty of Medicine Universitas Indonesia ID numbers 20-09-1037.

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Background Outdoor swimming athletes are often exposed to undesirable environmental conditions such as long-term sun exposure. The risk of sunburn can still occur in this population due to the loss of sunscreen and an increase in the sensitivity of the skin to ultraviolet rays, particularly ultraviolet B, in wet conditions. Some previous trials showed that organic sunscreens had a longer shelf-life than inorganic sunscreens after exercise due to their characteristics to bind better with the skin layer. Meanwhile, inorganic sunscreens tend to form layers on the skin’s surface so that they can be more easily removed. To our knowledge, no studies evaluate sunscreens' resistance, either inorganic or organic, after exercising in Indonesia. Objective This study aims to evaluate the persistence of inorganic versus organic sunscreens used by swimmers. The primary objective is to assess whether the inorganic sunscreen is as good as the organic sunscreen in the field of the persistence of sunscreens after swimming for 1.5 hours. Methods This study is a randomized, split-body, double-blind, noninferiority, and multicenter clinical trial in Cikini, Jakarta, Indonesia. An estimated 22 athletes in each group, who aged 18-40 years and practice in the morning or afternoon, will be randomized using a computer-generated randomization method. We calculated the sample size using the difference in the average decrease in sun protection factor (SPF) levels that is considered significant based on the clinical judgment set by the researchers, which was 5. Neither the research subjects nor the researchers are aware of the type of sunscreen that will be applied. The hypothesis will be tested using paired-sample t test or Wilcoxon to assess the difference of SPF levels in each group between organic and inorganic sunscreens with SPSS (version 20.0; IBM Corp). Results This study has been approved by the Ethical Committee Faculty of Medicine Universitas Indonesia and is funded by the International Publication Grant from Universitas Indonesia. The enrollment process was completed in December 2020. Conclusions This study will test all procedures in preparation for conducting the main study, including several potential obstacles and challenges from the perspective of participating physicians and eligible swimmers. The study results will be disseminated through publications in a peer-reviewed journal with Open Access format. This study will provide information about SPF 30 persistence in sunscreens and the best type of sunscreen to be used while swimming, particularly for athletes. Trial Registration ClinicalTrials.gov NCT04618536; https://clinicaltrials.gov/ct2/show/NCT04618536?term=NCT04618536 International Registered Report Identifier (IRRID) RR1-10.2196/42504