The Therapeutic Effects of Topical Cannabidiol (CBD) Products for Atopic Dermatitis

Last updated: August 28, 2023
Sponsor: Phoilex Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eczema (Atopic Dermatitis - Pediatric)

Atopic Dermatitis

Skin Infections/disorders

Treatment

Phoilex Releaf Gel

Clinical Study ID

NCT06022874
Pro00066042
  • Ages > 18
  • All Genders

Study Summary

The goal of this observational study is to learn about the potential therapeutic effects of topical CBD products produced by Phoilex Ltd., specifically the Releaf Gel, in those diagnosed with atopic dermatitis. Patients will be routinely assessed via questionnaire, and physical measurements will be taken with respect to the affected area studied in order to judge clinical efficacy.

The main question[s] it aims to answer are:

  • Did you experience an immediate increase in skin hydration?

  • Did you experience a soothing or comforting feeling on your irritated skin area? Please explain where your affected area is located, and also include at what time point this occurred. Example: Affected Area: Palm, Time Point: 1-hour post-application

  • Upon the affected area being in the healing phase, was your skin itch/scratch free for 4/6/10/12 hours (please circle)?

  • Did you experience immediate relief from your skin inflammation?

  • Did the study cream absorb quickly into your skin, without any greasy feeling?

  • Has your skin flare disappeared in 2 week(s)?

  • Has your skin condition appearance improved? (Yes/No)

Participants will apply Phoilex Releaf Gel (a cream) to their affected areas of atopic dermatitis. The questions listed above shall be discussed and observations recorded at the 0 week, 1 week, 2 week, and 4 week time points. Additional monitoring questions may be asked of the participants to ensure the safety of the product. A chart will be provided to the participants to track Phoilex Releaf Gel usage (how many pumps, and time of day) throughout duration of the study.

We hypothesize that Releaf gel will be suitable to ameliorate the common signs and symptoms of atopic dermatitis as well as improve patient quality of life.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Specifically, patients would be recruited based on the following inclusion criteriamust be over 18 years old and must be diagnosed with moderate-to-severe eczema.

Exclusion

Exclusion Criteria:

  • Exclusion criteria would include not currently using any steroids or biologics, notcurrently using any other topical products, not pregnant, not breast feeding, nor haveany allergies to any ingredients listed within the formula of the Releaf gel. Anegative pregnancy test will need to be confirmed prior to patient receiving PhoilexReleaf Gel. Lastly, participants who have been diagnosed with anxiety or depressionwith a classification of greater than mild anxiety or mild depression will beexcluded. As such, screening for possible candidates for the clinical trial willinclude questions and a brief assessment on participants mental health by studydoctor/physician.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Phoilex Releaf Gel
Phase:
Study Start date:
July 15, 2023
Estimated Completion Date:
October 30, 2023

Connect with a study center

  • Phoenix Medical Spa X Peak Human

    Brampton, Ontario L6W 3E1
    Canada

    Active - Recruiting

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