A 56-day clinical study evaluated Revodiol Calming Cream on pediatric and adult participants with mild to moderate atopic-prone skin under dermatological supervision. The product was applied twice daily, and efficacy was assessed through dermatological scoring, instrumental measurements, and subjective questionnaires. Results aimed to show improvements in barrier function, hydration, skin texture, and reduction of erythema, dryness, and pruritus, with feedback on comfort and quality of life.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Apply twice a day on the affected skin area to protect it, previously cleaned and dried. No rinsing is required. Volunteers were instructed not to use any other cosmetic product in the study area until the end of the study.
i+Med S.Coop.
Vitoria-Gasteiz, Álava, Spain
SCORAD (SCORing Atopic Dermatitis) Index
The assessment with the SCORAD index included lesion extent and the intensity of objective parameters such as erythema, edema/papules, exudation/crusting, lichenification, excoriation, and dryness, as well as subjective symptoms including pruritus and sleep disturbance. The scale evaluates symptoms from 0 (no signs) to 3 (severe).
Time frame: 56 days
Biometric Analysis
Using Mexameter® MX 18 probe anti-erythema efficacy was determined by measuring the light reflected by the skin .
Time frame: 56 days
Biometric Analysis
Cutaneous topography was evaluated using the Visioscan®
Time frame: 56 days
Biometric Analysis
Skin barrier function efficacy was determined by measuring the transepidermal water loss (TEWL) using the Tewameter® TM 300 probe .
Time frame: 56 days
Biometric Analysis
Skin renewal efficacy was determined by measuring skin desquamation using Corneofix® F 20 sheets.
Time frame: 56 days
Subjective evaluation
In adult participants, quality of life was assessed using the validated Dermatology Life Quality Index (DLQI) questionnaire. The DLQI consists of 10 items covering symptoms, daily activities, leisure, work/school, personal relationships, and treatment.
Time frame: 56 days
Adverse events record
Adverse events record
Time frame: 28 and 56 days
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Tolerance evaluation
At the end of the study, the dermatologist assessed local tolerance based on the presence and intensity (mild, moderate, severe) of erythema, xerosis/desquamation, oedema, exudation, comedogenicity, and pigmentation alterations. Causality was also rated according to the scale: not related, improbable, possible, probable, certain, or not assessable.
Time frame: 56 days