Method – Soothing efficacy – HYDRO-B18

EXPERIMENTAL PROTOCOL

PANEL: 20           SEX: women and man           AGE: 21- 49

INCLUSION CRITERIA

  • Good state of general health

  • No dermatopathies

  • Absence of cutaneous lesions or other lesions in the interested area that could interfere with the study

  • No pharmacological treatment in progress

  • Promise not to change the usual daily routine

  • No pregnancy or breastfeeding state

  • No similar treatment for the entire duration of the test

  • No participation in similar study by at least 30 days

  • Signing of the informed consent form (Annex I)

LENGTH OF THE STUDY

96 hours

ANALYSIS TIMING

basal conditions (tb) (prior to the induction of erythema), then 4 hours (t0), 24 hours (t1), 48 hours (t2), 72 hours (t3) after the removal of the patch.

DESIGN OF THE STUDY

Selection of the test area. 5 sites (0,64 cm2) on the forearm area of each volunteer are defined and classified as follows:

  • Site A: erythema control site;

  • Site B: occlusion control site;

  • Site C: site of application of the product Hydro B18 for soothing effectiveness (concentration of use 1%);

  • Site D: site of application of the product Bisabolol for soothing effectiveness (concentration of use 1%);

  • Site E: site of application of the product Ammonium Glycyrrhizate for soothing effectiveness (concentration of use 1%).

    Induction of erythema. The erythema was induced on 4 of the 5 described sites by applying 20 μl/cm2 of a 3.5% solution of sodium lauryl sulfate (SLS) in occlusion for 24 hours using preformed cells Van der Ben (FIRMA SpA, Florence, Italy). After 4 hours, 24 hours and 48 hours from patch removal, different product was applied on site C,D and E. Site A represents the control site: after induction of erythema no product was applied. Site B was the untreated control area in which only the occlusion was performed without applying any chemical.

METHOD OF APPLICATION

The product was applied on its designated site in a defined dose, left on the site for 15 minutes and possibly removed in case of excess. The standard was applied on its designated site, left on the site for 15 minutes, massaged and possibly removed in case of excess.

INSTRUMENTAL EVALUATION

Device

Tewameter TM 300 (Cutometer MPA580, Courage&Khazaka, Cologne, Germany)

Mexameter MX 18 (Cutometer MPA580, Courage & Khazaka, Cologne, Germany)

Technique

Measurement of the two components mainly responsible for the color of the skin: melanin and hemoglobin (erythema) by reflectance. A probe with a 5 mm diameter emits three selected light wavelengths (568 nm, 660 nm and 870 nm) in order to quantify the amount of selected biochromophores (melanin, hemoglobin) thus providing an arbitrary Melanin index (MI) 0-999 and Erythema Index (EI), range 0-999.