A DEPIGMENTATION TOPICAL TREATMENT PROGRAM ENHANCES A PREVIOUS CHEMICAL PEELING OF THE FACE 389 verify the fulfi llment of the study inclusion/exclusion criteria listed previously. A clinical and instrumental evaluation of skin quality and degree of skin pigmentation using the digital analysis of cutaneous surface (DACS) was performed. Durin g study visit 2, the following procedures were completed for each study subject: clinical and DACS-mediated evaluation of skin quality and degree of skin pigmentation recording of any changes in concomitant treatments recording of any adverse event (AE) or serious AE (SAE), with particular attention to those that could have occurred in the treated areas (e.g., burning, redness, and itching) collection of unused (or partially used) study products and verifi cation of their use made by the subjects completion by the inves- tigator of the questionnaire on treatment satisfaction and compilation by the subjects of the questionnaires on treatment satisfaction and on the pleasantness and ease of use of the hyperpigmentation topical treatment program. The 1 6 study participants were suffi ciently compliant with the prescribed treatments, and none of them dropped out prematurely. No AEs or SAEs were reported during the study. Local tolerability of the three components of the hyperpigmentation topical treat- ment program was assessed by the study investigators, and no safety concern was issued. Prima ry study end points were hyperpigmentation reduction and change in skin texture induced by the investigational product applied for 30 d after a chemical peeling. The reduction of hyperpigmentation and the changes in skin texture were assessed by instru- mental tests (DACS), described in more detail in the following texts (19–22). Because the study product was intended for at-home administration, the study included as secondary end points the ease of use of the treatment, its pleasantness, the overall satisfaction of patients and study investigators, and the safety and tolerability of the treatment. Table I Patients’ Demogr a phic Data and Baseline Values for Skin Parameters Parameter Statistics/categories Pigment solution (N = 29) Age (years) N 16 Mean (SD) 52.75 (11.40) Median 51.00 Minimum/maximum 28.00/77.00 Medical history [N (%)] No 9 (56.25%) Yes 7 (43.75%) Product used for peeling [N (%)] Lightening peel 16 (100.0%) Pregnancy test [N (%)] No 9 (56.25%) Yes 7 (43.75%) Negative 7 (100.0%) Melanin concentration N 16 Mean (SD) 0.62 (0.07) Median 0.64 Minimum/maximum 0.50/0.74 Skin texture N 16 Mean (SD) 11.17 (3.82) Median 10.8 Minimum/maximum 6.62/20.29 Pigment uniformity N 16 Mean (SD) 0.05 (0.01) Median 0.05 Minimum/maximum 0.03/0.08
JOURNAL OF COSMETIC SCIENCE 390 PRODU CTS The h yperpigmentation topical treatment program (Pigment Solution™ Program, Relife S.r.l., Florence, Italy) is a cosmetic treatment specifi cally formulated to reduce hyperpig- mentation and achieve a uniform skin tone. It consists of three products: (i) a preparation cleanser—a mild detergent, containing a mixture of soothing ingredients, formulated to cleanse and prepare the skin for treatment, facilitating dermal penetration of depigment- ing agents (ii) a day cream (kojic acid 0.3%, vitamin E 0.05%, vitamin A 0.005%, and AQUAXYL™ complex 3%) (Seppic SA) (iii) a night cream (kojic acid 0.3%, glycolic acid 5.7%, AQUAXYL complex 3%, and scrubbing beads 1.5%). The tre atment was administered at home. All patients were instructed to apply the products every day for 30 consecutive days. Subjects had to apply the day cream in the morning (two fi ngertips of cream on the whole face) and the night cream in the evening (two fi nger- tips of cream on the whole face), massaging with circular movements in the areas affected by hyperpigmentation (sun spots, age spots, and photosensitivity spots). A fi ngertip unit corresponds to about 0.43 g of cream for a female adult. Subjects had to prepare the skin using the preparation cleanser before each application (2 mL of cleanser on the whole face, 1 mL in the morning, 1 mL in the evening, massaged for 2 min, and then rinsed with water). No increase or reduction in daily applications was allowed. The study products were supplied by the study Sponsor Relife S.r.l. The sup erfi cial chemical peeling/depigmentation treatment given within 7 d before the study enrollment included a fi xed-dose combination of salicylic acid, pyruvic acid, and retinoic acid, with the integration of the depigmentation agents Lumiskin (diacetyl bol- dine, a tyrosinase inhibitor) and SEPIWHITE, containing lipoaminoacid (undecylenoyl phenylalanine) acting as a selective antagonist of α-melanocyte-stimulating hormones, involved in the regulation of melanogenesis. DACSS Th e tota l amount of melanin, pigment uniformity, and the skin texture in target skin areas of each subject were assessed using the Antera 3D® system (Miravex Limited, Dublin, Ireland), an objective, reliable, fast, noninvasive, nonpainful tool for DACS based on the use of multispectral sources and on the 3D mapping of the skin surface. In more detail, the Antera 3D camera produces a multidirectional light beam by emitting diodes of seven different light wavelengths, spanning the entire visible spectrum. The camera col- lects the refl ected light and uses the refl ection angle to produce a 3D reconstruction of the skin surface. This reconstruction is based on shape from shading, extensively modifi ed to eliminate skin glare and improve the accuracy of measured data. The refl ectance data are transformed into skin absorption coeffi cients and used to quantify melanin concentration using the mathematical correlation with known spectral absorption data of this chromo- phore. Target sk in areas were photographed with the Antera 3D camera (fi eld of view: 56 × 56 mm resolution: 0.1 mm 3D depth resolution: 0.01 mm accuracy: ±5%). Associated Antera 3D software allows the analysis of the skin in 2D and 3D, together with a multispectral analysis of epidermis and dermis pigmentation. The Antera 3D software allows the op- erator to select the investigated skin area, which is automatically recognized during the
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