The Therapeutic Effects of Topical Cannabidiol (CBD) Products for Atopic Dermatitis
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2023
CompletedFirst Submitted
Initial submission to the registry
August 28, 2023
CompletedFirst Posted
Study publicly available on registry
September 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2023
CompletedSeptember 5, 2023
August 1, 2023
3 months
August 28, 2023
August 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Will topically applied CBD be effective in reducing the appearance/clearing of atopic dermatitis after 4 weeks of study treatment?
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)
5 weeks
Study Arms (1)
Patient's Diagnosed with Atopic Dermatitis
Patient's Diagnosed with Atopic Dermatitis
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Phoilex Ltd.lead
- Phoenix Medical Spa X Peak Humancollaborator
Study Sites (1)
Phoenix Medical Spa X Peak Human
Brampton, Ontario, L6W 3E1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanjeev Goel, MD
Phoenix Medical Spa X Peak Human
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2023
First Posted
September 5, 2023
Study Start
July 15, 2023
Primary Completion
September 30, 2023
Study Completion
October 30, 2023
Last Updated
September 5, 2023
Record last verified: 2023-08