Clinical trial NCT06022874: The Therapeutic Effects of Topical Cannabidiol (CBD) Products for Atopic Dermatitis
Official title: The Therapeutic Effects of Topical Cannabidiol (CBD) Products for Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Lead sponsor: Phoilex Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Phoenix Medical Spa X Peak Human
First posted: 2023-09-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with moderate to severe atopic dermatitis will be selected and recruited from medical clinics, social media, as well as invitation should they meet the inclusion criteria. Participants must be able to travel to clinic location in Brampton.

Brief 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 Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Will topically applied CBD be effective in reducing the appearance/clearing of atopic dermatitis after 4 weeks of study treatment?
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Phoenix Medical Spa X Peak Human
state: Ontario
Study officials:
affiliation: Phoenix Medical Spa X Peak Human
name: Sanjeev Goel, MD
role: PRINCIPAL_INVESTIGATOR
References: