NCT07301658

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

November 27, 2025

Last Update Submit

December 10, 2025

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Biometric Analysis

    56 days

  • Biometric Analysis

    56 days

  • Biometric Analysis

    56 days

  • Biometric Analysis

    56 days

  • Subjective evaluation

    56 days

  • +2 more secondary outcomes

Study Arms (2)

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.

Interventions

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.

Dermatitis efficacy test under dermatological controlDermatitis efficacy test under dermatological control and pediatric supervision

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

i+Med S.Coop.

Vitoria-Gasteiz, Álava, 01510, Spain

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2025

First Posted

December 24, 2025

Study Start

February 27, 2023

Primary Completion

June 6, 2023

Study Completion

August 7, 2024

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)