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| Name | Class |
|---|---|
| Centro Médico Complutense Grupo Virtus | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dermatitis efficacy test under dermatological control | Experimental |
| |
| Dermatitis efficacy test under dermatological control and pediatric supervision | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel dermocosmetic product containing cannabidiol (CBD) and Annona cherimola fruit extract. | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Biometric Analysis | Using Mexameter® MX 18 probe anti-erythema efficacy was determined by measuring the light reflected by the skin . | 56 days |
| Biometric Analysis | Cutaneous topography was evaluated using the Visioscan® |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| i+Med S.Coop. | Vitoria-Gasteiz | Álava | 01510 | Spain |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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|
| 56 days |
| Biometric Analysis | Skin barrier function efficacy was determined by measuring the transepidermal water loss (TEWL) using the Tewameter® TM 300 probe . | 56 days |
| Biometric Analysis | Skin renewal efficacy was determined by measuring skin desquamation using Corneofix® F 20 sheets. | 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. | 56 days |
| Adverse events record | Adverse events record | 28 and 56 days |
| 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. | 56 days |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |