PRODUCT: HYDRO-B18®

INCI NAME: Aqua, Polyglyceryl-6 Caprylate, Glycyrrhetinic Acid, Proline

AIM OF THE STUDY

Clinical safety evaluation of cosmetic products applied in single dose on the intact skin. Identification and classification of skin irritation and sensitization potential of the tested products

EXPERIMENTAL PROTOCOL

PANEL: 20                          SEX: women and men                         AGE: 21 – 55

 

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: t0, t48 hours, t96 hours

 

DESIGN OF THE STUDY: active product Vs control; volar part of the forearm.

The product is left in contact with the skin for 48 hours and then the removal of the patch occurs. Follow up after 48 hours from the removal. Each volunteer has been educated in order to avoid washing the test area for the entire duration of the test.

METHOD OF APPLICATION: Product: 10 μl in the preformed cell Van der Ben (Firma S.p.A., Firenze, Italia) of 1 cm2 area, using a pre-filled syringe

Control: preformed empty cell Van der Ben (Firma S.p.A., Firenze, Italia) of 1 cm2 as it is

CLINICAL EVALUATION

DOCTOR: Elisabetta Moia, MD, Specialist in dermatology and venereology

 

ERYTHEMA            SCORE EDEMA      SCORE
       
No erythema                  0 No edema           0
Light (hardly visible)                1 Light (hardly visible)           1
Clearly visible               2 Clearly visible           2
Moderate               3 Moderate (raised skin)            3
Serious (dark  red with possible light eschars)                4 Strong (extended swelling even beyond the application area)            4

The product is classified according to the mean irritation index (IIM), which is calculated by adding erythema mean value and edema mean value obtained 48 hours after the application and 48 hours after the removal of the occlusion. This index allows the classification of the product in one of the following 4 classes.

                             IIM  CLASSIFICATION
                           < 0,5   Non irritating
                          0,5-2,0  Slightly irritating
                          2,0-5,0  Moderately irritating 
                          5,0-8,0 Severely irritating