Atopic Dermatitis (AD)NCT07301658
Efficacy and Safety of Revodiol Calming Cream® in Atopic Dermatitis.
A study testing Novel dermocosmetic product containing cannabidiol (CBD) and Annona cherimola fruit extract. in people with Atopic Dermatitis (AD), run by i+Med S.Coop. at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- Novel dermocosmetic product containing cannabidiol (CBD) and Annona cherimola fruit extract.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 27 Feb 2023to 7 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- Sun exposure or UVA rays during the study.
- Participation in another clinical study.
- Health problems that may compromise adherence to the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- Novel dermocosmetic product containing cannabidiol (CBD) and Annona cherimola fruit extract.
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Dermatitis efficacy test under dermatological control | Experimental | Not described Receives: Other: Novel dermocosmetic product containing cannabidiol (CBD) and Annona cherimola fruit extract. |
| Dermatitis efficacy test under dermatological control and pediatric supervision | Experimental | Not described Receives: Other: Novel dermocosmetic product containing cannabidiol (CBD) and Annona cherimola fruit extract. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 56 days
Secondary outcomes (7)
Biometric Analysis
Using Mexameter® MX 18 probe anti-erythema efficacy was determined by measuring the light reflected by the skin .
Measured: 56 days
Biometric Analysis
Cutaneous topography was evaluated using the Visioscan®
Measured: 56 days
Biometric Analysis
Skin barrier function efficacy was determined by measuring the transepidermal water loss (TEWL) using the Tewameter® TM 300 probe .
Measured: 56 days
Biometric Analysis
Skin renewal efficacy was determined by measuring skin desquamation using Corneofix® F 20 sheets.
Measured: 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.
Measured: 56 days
Adverse events record
Adverse events record
Measured: 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.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start27 Feb 2023
- Primary completion6 Jun 2023
- Study completion7 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- i+Med S.Coop.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centro Médico Complutense Grupo Virtus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301658
- Sponsor's protocol ID
- caCBD
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness and Safety of Revodiol Calming Cream® in the Management of Atopic Dermatitis Under Dermatological Control.
- ClinicalTrials.gov ID
- NCT07301658
- Acronym / sponsor ID
- caCBD
- Conditions
- Atopic Dermatitis (AD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- i+Med S.Coop.Industry (pharma, biotech, devices)
- Collaborators
- Centro Médico Complutense Grupo Virtus
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermatitis efficacy test under dermatological control | Experimental | Other: Novel dermocosmetic product containing cannabidiol (CBD) and Annona cherimola fruit extract. |
| Dermatitis efficacy test under dermatological control and pediatric supervision | Experimental | Other: Novel dermocosmetic product containing cannabidiol (CBD) and Annona cherimola fruit extract. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Sex: both.
- Age: from 0 months onwards (includes children and adults).
- Atopic-prone skin.
- Mild to moderate flare-up.
- Skin dryness.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Dermatitis efficacy test under dermatological control, Dermatitis efficacy test under dermatological control and pediatric supervision |
Primary outcome
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).
7 secondary outcomes
Biometric Analysis
Time frame: 56 days
Biometric Analysis
Time frame: 56 days
Biometric Analysis
Time frame: 56 days
Biometric Analysis
Time frame: 56 days
Subjective evaluation
Time frame: 56 days
Adverse events record
Time frame: 28 and 56 days
Tolerance evaluation
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel dermocosmetic product containing cannabidiol (CBD) and Annona cherimola fruit extract. in people with Atopic Dermatitis (AD), run by i+Med S.Coop. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCORAD (SCORing Atopic Dermatitis) Index (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.