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Completed

NCT Number: NCT07301658

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

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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Key information

Conditions

Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

i+Med S.Coop.

Vitoria-Gasteiz, Álava, 01510, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Biometric Analysis

    Time frame: 56 days

    Using Mexameter® MX 18 probe anti-erythema efficacy was determined by measuring the light reflected by the skin .

  2. Biometric Analysis

    Time frame: 56 days

    Cutaneous topography was evaluated using the Visioscan®

  3. 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 .

  4. Biometric Analysis

    Time frame: 56 days

    Skin renewal efficacy was determined by measuring skin desquamation using Corneofix® F 20 sheets.

  5. 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.

  6. Adverse events record

    Time frame: 28 and 56 days

    Adverse events record

  7. 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.

Sponsors and collaborators

Lead sponsor

i+Med S.Coop.

Industry

Collaborators

  • Centro Médico Complutense Grupo Virtus

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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