Abstract
[Introduction] To prevent and improve wrinkles, continuous delivery of moisturizing ingredients into the epidermis is necessary, stopping evaporation of water before the groove reaches the dermis. However, the stratum corneum has a robust barrier function and limited permeability for substances. The objective of this randomized controlled trial was to analyze the efficacy and safety of scattered needling immediately followed by the application of an essence containing moisturizing ingredients.
[Materials and Methods] Eligible participants were randomly assigned to the intervention group (n = 13) or the control group (n = 12). The participants in the intervention group were instructed to perform the following procedure once daily for two weeks: (1) application of a 0.3-mm intradermal thumbtack needle at the corner of one eye after face washing and disinfection, (2) tapping on the needle approximately five times/second for one minute, and (3) immediate application of a specified essence. The participants in the control group were instructed to perform similar skin care procedures, but with a "needleless" intradermal thumbtack needle. The primary outcome measure was the wrinkle grade according to the Guidelines for Evaluation of Anti-Wrinkle Products, wherein grade 0 indicates no wrinkles and grade 7 indicates markedly deep wrinkles. The results were evaluated by quartile. For efficacy evaluation, a decrease in the score by <1 was defined as "reduction" and a decrease by ≥ 1 as "improvement." The secondary outcome measures were adverse events and the degree of pain from acupuncture measured by a numerical rating scale.
[Results] In the intervention group, efficacy was demonstrated in nine (69%) participants including four with "improvement" and five with "reduction," while three (25%) participants achieved "reduction" in the control group, showing a risk ratio of 2.8 (95% confidence interval: 1.0-7.9, P = 0.03). Adverse events in the intervention group were pruritus (n = 4), pain (n = 3), discomfort at the acupuncture site (n = 3), and fatigue (n = 1). The mean pain score was 1.0 ± 0.7 in the intervention group and 0.3 ± 0.5 in the control group (P = 0.01).
[Conclusions] A two-week skin care program consisting of scattered needling with an intradermal thumbtack needle immediately followed by essence application was effective in reducing fine wrinkles in about 70% of the participants, although accompanied by slight pain, with the pain percentage about three times higher than that experienced in application of essence alone.
