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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06022874
Recruitment Status : Recruiting
First Posted : September 5, 2023
Last Update Posted : September 5, 2023
Sponsor:
Collaborator:
Phoenix Medical Spa X Peak Human
Information provided by (Responsible Party):
Phoilex Ltd.

Study Description
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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.


Condition or disease Intervention/treatment
Atopic Dermatitis Other: Phoilex Releaf Gel

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Therapeutic Effects of Topical Cannabidiol (CBD) Products for Atopic Dermatitis
Actual Study Start Date : July 15, 2023
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Groups and Cohorts
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Group/Cohort Intervention/treatment
Patient's Diagnosed with Atopic Dermatitis
Patient's Diagnosed with Atopic Dermatitis
 Other: Phoilex Releaf Gel

Patients will be given the Releaf Gel to apply to the affected areas daily. They will be examined at the following time points: Immediately after application, 1 week, 2 weeks, and 4 weeks.

The instructions given to the patient shall be to apply one pump per every affected area, wash hands before applying to affected area, apply twice a day (morning, and evening), apply on clean skin, and application after showering is advised.

The number of pumps of Phoilex Releaf gel will be documented within a chart provided to the patient. It is suggested that not more than 25 lesions compassing an area greater than 50 cm² in total be treated during the course of this study.

The maximum dose would be 240 mL of Phoilex Releaf gel in 30 days. The minimum dose would be 0.5 mL (one pump) of the Phoilex Releaf gel in 30 days. The maximum daily dose of CBD per day 46 mg per application, equivalent to 92 mg per day.


Outcome Measures
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Primary Outcome Measures :
  1. Will topically applied CBD be effective in reducing the appearance/clearing of atopic dermatitis after 4 weeks of study treatment? [ Time Frame: 5 weeks ]

    Outcome will be measured based on observations recorded at 0 weeks, 1 week, 2 week, and 4 week time point, not limited to physical assessment, clinical photography, and the responses of questions below:

    • 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06022874


Contacts
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Contact: Sanjeev Goel, MD (647) 703-2085 drgoel@peakhuman.ca
Contact: Sarina Pilaroscia info@phoilex.com

Locations
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Canada, Ontario
Phoenix Medical Spa X Peak Human Recruiting
Brampton, Ontario, Canada, L6W 3E1
Contact: Michelle Rodrigues    (647) 703-2085    michelle@peakhuman.ca   
Principal Investigator: Sanjeev Goel, MD         
Sponsors and Collaborators
Phoilex Ltd.
Phoenix Medical Spa X Peak Human
Investigators
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Principal Investigator: Sanjeev Goel, MD Phoenix Medical Spa X Peak Human
More Information
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Responsible Party: Phoilex Ltd.
ClinicalTrials.gov Identifier: NCT06022874    
Other Study ID Numbers: Pro00066042
First Posted: September 5, 2023    Key Record Dates
Last Update Posted: September 5, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases