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

I

i+Med S.Coop.

Status

Completed

Conditions

Atopic Dermatitis (AD)

Treatments

Other: Novel dermocosmetic product containing cannabidiol (CBD) and Annona cherimola fruit extract.

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

42 participants in 2 patient groups

Dermatitis efficacy test under dermatological control
Experimental group
Treatment:
Other: Novel dermocosmetic product containing cannabidiol (CBD) and Annona cherimola fruit extract.
Dermatitis efficacy test under dermatological control and pediatric supervision
Experimental group
Treatment:
Other: Novel dermocosmetic product containing cannabidiol (CBD) and Annona cherimola fruit extract.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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