Efficacy and Safety of Revodiol Calming Cream® in Atopic Dermatitis.

Evaluation of the Effectiveness and Safety of Revodiol Calming Cream® in the Management of Atopic Dermatitis Under Dermatological Control.

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 Overview

• Status: Completed
• Conditions: Atopic Dermatitis (AD)
• Intervention / Treatment: Other: Novel dermocosmetic product containing cannabidiol (CBD) and Annona cherimola fruit extract.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Álava
    • Vitoria-Gasteiz, Álava, Spain, 01510
      • i+Med S.Coop.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Sex: both.
• Age: from 0 months onwards (includes children and adults).
• Atopic-prone skin.
• Mild to moderate flare-up.
• Skin dryness.
• Signed informed consent (by the volunteer or legal guardian as applicable).
• Adequate understanding of the clinical study by the participant or legal guardian.
• Good physical and psychological health.
• No application of any product on the experimental area on the first day of the trial.
• Availability to guarantee visits to the research center.

Exclusion Criteria:

• History of allergies to cosmetic products.
• Recent surgery or treatments in the study area.
• Oncology patients.
• Use of antihistamines and antibiotics within 15 days prior to the start of the study.
• Treatment with antihistamines, antibiotics, corticosteroids, immunosuppressants or completion of such treatment within 15 days prior to the start of the study.
• Use of any other product for dermatitis during the study.
• Sun exposure or UVA rays during the study.
• Participation in another clinical study.
• Health problems that may compromise adherence to the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dermatitis efficacy test under dermatological control	Other: Novel dermocosmetic product containing cannabidiol (CBD) and Annona cherimola fruit extract.; 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.
Experimental: Dermatitis efficacy test under dermatological control and pediatric supervision	Other: Novel dermocosmetic product containing cannabidiol (CBD) and Annona cherimola fruit extract.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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®	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

Collaborators and Investigators

• Sponsor: i+Med S.Coop.
• Collaborators: Centro Médico Complutense Grupo Virtus

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Actual): June 6, 2023
• Study Completion (Actual): August 7, 2024

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: caCBD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No