Clinical Trial for the Evaluation of Annurca Apple Peel Oleolite for the Treatment of Skin Hyperpigmentation

The skin effects of the AAO were evaluated through a monocentric, double-blind, placebo-controlled, parallel-arm, randomized clinical study. Healthy Italian subjects (age 40-65; n=48) were enrolled in this 4-week study. Before participating, each subject signed a written informed consent that contained the aim and the type of the study, the list of the cosmetic-grade ingredient employed fort the preparation of the cosmetic formulation, the rules to be followed, and any known or potential adverse reactions that might result from using the test products.

All subjects were selected based on the presence of photodamage and hyperpigmentation. Enrolled subjects underwent to 30-day washout period, in which they were instructed to stop using their usual cosmetic products, whereas they were permitted to continue their normal facial treatment regimen (e.g., facial cleanser, make-up and make-up removal) that did not contain ingredients with lightening or whitening action. Once the wash-out period elapsed, subjects were supplied with test products (placebo and the same formulation added with AAO).

Panelists had to apply the assigned emulsion twice daily (morning and evening) for 4 weeks. The application amount had to be approximately 0.3 g of product (two pumps) on a dry or slightly moistened face. Massage in, avoiding direct contact with the eyes. Upon application, in case of individual hypersensitivity, discontinue treatment. Do not use on irritated or chapped skin. For the evening application wait for at least 1 h before bedtime.

Digital images of all subjects were captured at baseline and at weeks 2 and 4, with VISIA® 7th (Canfield Scientific Inc., Parsippany, NJ 07054 USA). The skin imaging system exploits RGB technology to record and measure UV and brown spots, and skin tone. Before image capture, subjects were equilibrated in a controlled temperature room (22 ± 2 °C) for 30 minutes. The hair of the participants was tied up and their clothing was covered with black cloth. The images were taken by the same operator using the same imaging equipment under the same conditions (lighting, distance, head position, etc.) at all time points. Accurate subjects' repositioning was obtained by comparing the live image with the ghost-baseline digitally stored photo. Computer analysis of the digital images allowed quantification of the hyperpigmentation and dark spots.

Facial skin color and spots were also detected through reflectance and spectro-photometric skin devices, like Skin-Colorimeter® CL 400 and Mexameter® MX 18 (Courage+Khazaka electronic GmbH). Specifically, the skin luminosity, melanin index and skin complexion were monitored during the trial.