The study protocol should to be updated (major updates), following the second Health Canada review /requests. The study has been withdrawn form the REB review and will not be performed at SickKids.
Sponsor study identifier
interventional
0
1 country
1
Study Start
August 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Epidermolysis bullosa (EB) is rare, devastating, and currently incurable genetic blistering disorders characterized by fragility of skin and mucosal membranes. Therapeutic options for EB are limited. Acute and chronic wounds cause pain, itching and infection, altering quality of life and impair wound healing. In absence of a cure, wound care is paramount to alleviate suffering. Anecdotal experience suggest that CBD application alleviates the pain and itching and improves wound healing by controlling the inflammatory process. We propose to undertake a phase II/III study exploring the safety, tolerability and efficacy of topical application of 3% Cannabidiol cream (CBD) on acute and chronic wounds affecting patients with EB. We are doing this trial to determine safety and tolerability of topical CBD cream in a cohort of RDEB patients with chronic wounds (phase II trial), and to evaluate the efficacy and safety of CBD cream in EB with acute and chronic wounds in promoting wound healing, decrease blister formation, pain, itching and improve overall quality of life (phase III trial)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 27, 2020
Actual (reported)November 3, 2020
Actual (reported)September 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Group A (patients with acute wounds). Difference in the total wound count (blister, open and closed wounds) compared to baseline
Difference in the total wound count (blister, open and closed wounds) compared to baseline
8 weeks
Group B (patients with chronic wounds). Percent change in the surface area of patients treated vs patients on placebo compared to baseline
Percent change in the surface area of patients treated with CBD vs patients on placebo compared to baseline
8 weeks
Group B (patients with chronic wounds). Proportion of treated patients that had more than 75% wound shrinkage
Proportion of patients that had more than 75% wound shrinkage (on the side of the body treated with CBD - in phase 3), compared to baseline.
8 weeks
Group B. Proportion of treated patients that had more than 50% wound shrinkage
Proportion of patients that had more than 50% wound shrinkage (on the side of the body treated with CBD - in phase 3), compared to baseline.
8 weeks
Percent changes in pain scores compared to baseline
• Percentage of patients that needed to stop the medication as a result of an adverse event
8 weeks
Percentage of patients who experienced a serious adverse event
8 weeks
Percentage of patients who had detectable levels of CBD in the blood
8 weeks
• Percentage of patients who had clinical and laboratory evidence of infection in the wounds
8 weeks
All participant of phase 2 will receive CBD cream for their chronic wound treatment. This is an open-label part of the study.
Each participants of the phase 3 will receive the active study medication (AVCN583601) during the entire study treatment period on the one of his body sides, and placebo cream - on the other body side simultaneously (left/right). So, each participant will be his own control. The research support pharmacy will randomize, which side of the body participant should apply CBD cream on, and provide two jars with the study medications, labeled accordingly ( Left /Right).
Topical application twice daily for 4 weeks (phase 2) and for 8 weeks (phase 3).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Hospital for Sick Children
Toronto, Ontario, M5G1X8, Canada
Elena Pope, MD
The Hospital for Sick Children
0 participants (actual enrollment reported by the registry).
First Submitted
October 27, 2020
First Posted
November 3, 2020
Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (0 -no pain) and on the right (10- worst pain ever). The patient is asked to mark their pain level on the line at each study visit. The pain is scored using the VAS by measuring the distance in centimeters (0-10) from the "no pain" anchoring point. Difference in the pain score assessed using VAS, reported by the patient, between baseline and week 4, and week 8 visits will be calculated and multiplied by 10 to get result in percents(%).
8 weeks
Percent changes in itch scores compared to baseline
The intensity of itch is measured using the Visual Analog Scale for itch (VAS).It is a 10 cm line with anchor statements on the left (0- no itching) and on the right (10 -worst possible itching). The patient is asked to mark the intensity of itch on the line at each study visit. The itch is scored using the VAS by measuring the distance in centimeters (0-10) from the "no itch" anchoring point. the difference in the itch score as assessed using VAS( reported by the patient) between the first and visits Week 4 and Week 8, will be multiplied by 10 to get result in percents.
8 weeks
Percent changes in iscorEB (instrument for scoring clinical outcomes for research of EB), patient and clinician scores compared to baseline
iscorEB is a measurement tool for evaluating the disease severity in EB patient. It evaluates the cutaneous, mucosal and other organ impact of EB and includes clinician and patient reported outcomes in a single instrument. Score ranges between 0-120 for both reported outcomes. Patient portion of this instrument contains 15 questions. Each question has a score range from 0-8.Total score range for iscorEB patient portion is between 0 and 120. Reduction in iscorEB scores indicates improvement. An increase in score indicates deterioration. The difference in total patient and clinician scores between baseline and Week 4 ,8 visits will be divided by 120 ( max score for each portion)and multiplied by 100, to get the results in percents.
8 weeks
Percent changes in Quality of Life in Epidermolysis Bullosa Questionnaire score (QOLEB) EBQOL scores compared to baseline
QOLEB is a measurement tool containing 17 questions. Each question has a score range from 0-3.Total score range is between 0 and 51. Difference in the total scores between baseline and the study visits week 4, 8, will be divided by 51 and multiplied by 100 to get the result in percents.
8 weeks
correlation between patient's impression of improvement (VAS) and objective tools
Patient's impression of improvement is measured using the Visual Analog Scale (VAS). It is a 10 cm line with 3 anchor statements: on the left -"worsening", mid- "no changes", and on the right - "improvement". The patient is asked to mark his/her impression of improvement on the line at the final study visit. It will be scored by measuring the distance in centimeters (0-5) from the "no changes" anchoring point. The difference in this score as assessed using VAS( reported by the patient) between the baseline and EOS visit ,will be multiplied by 20 to get result in percents.
8 weeks
Contact the study team to confirm eligibility.
Study Start
August 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 18, 2021
Record last verified: 2021-06
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Source: ClinicalTrials.gov.
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