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

December 10, 2025 updated by: i+Med S.Coop.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SCORAD (SCORing Atopic Dermatitis) Index
Time Frame: 56 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biometric Analysis
Time Frame: 56 days
Using Mexameter® MX 18 probe anti-erythema efficacy was determined by measuring the light reflected by the skin .
56 days
Biometric Analysis
Time Frame: 56 days
Cutaneous topography was evaluated using the Visioscan®
56 days
Biometric Analysis
Time Frame: 56 days
Skin barrier function efficacy was determined by measuring the transepidermal water loss (TEWL) using the Tewameter® TM 300 probe .
56 days
Biometric Analysis
Time Frame: 56 days
Skin renewal efficacy was determined by measuring skin desquamation using Corneofix® F 20 sheets.
56 days
Subjective evaluation
Time Frame: 56 days
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
Time Frame: 28 and 56 days
Adverse events record
28 and 56 days
Tolerance evaluation
Time Frame: 56 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
i+Med S.Coop.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centro Médico Complutense Grupo Virtus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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