Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04613102
Status:
WITHDRAWN
Last Update Posted:
2021-06-18
First Post:
2020-10-27
Brief Title:
The Efficacy and Safety of 3 Cannabidiol CBD Cream in Patients With Epidermolysis Bullosa A Phase IIIII Trial
Sponsor:
Elena Pope
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
The Efficacy and Safety of 3 Cannabidiol CBD Cream in Patients With Epidermolysis Bullosa A Phase IIIII Trial
Status:
WITHDRAWN
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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study protocol should to be updated major updates following the second Health Canada review requests The study has been withdrawn form the REB review and will not be performed at SickKids
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 IIIII 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
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 IIIII 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
Detailed Description:
Phase II is an open-label part of the study We are planning to enroll in this phase 10 patients diagnosed with Epidermolysis Bullosa with chronic wounds and treat them with topical application of 3 Cannabidiol cream AVCN583601 for 4 weeks
Full study procedures phase II of the trial see below
Visit 1 Screening Visit A screening form will be completed and patients who are willing to enroll and meet the eligibility criteria will be asked to sign the consentassent form Patients already on cannabinoids will be instructed to discontinue their treatment two weeks prior to the next visit wash-out period Subjects who were not treated with antibiotics or corticosteroids in the previous 2 weeks for topical and 4 weeks for systemic agents will start the trial at this time
Visit 2 Baseline Visit A baseline data collection form will be completed We will select for the study treatment a chronic wound present for more than 4 weeks not measuring more than 1000 cm2 The surface area of the wound and quality of the wounds will be assessed and documented using the SWIFT medical wound assessment app a validated tool that allows serial estimates and measurements of the wound surface areas Bacterial swabs of selected target wound and medical photographs of the target wounds will be taken For the pain intensity assessment we will use a 100 mm visual analog scale VAS where 0 is no pain and 10- the worst pain ever experienced while the DN4 scale will be used for assessment of neuropathic pain For itch assessments we will ask patients to determine the degree of itching experienced that day using a 100 mm horizontal VAS for itch Patients will be provided with the study medication during this study visit and instructed to apply the cream twice a day for 4 weeks
Blood sample 3 ml will be taken to measure cannabinoid level in the blood Visit 3 End of study visit Patients will be assessed at 4 weeks when we will evaluate tolerability of the CBD oil and safety eg burning sensation pain itch local irritation systemic symptoms In addition we will calculate the surface area change from previous visit as well as the characteristics of the wounds using the SWIFT medical wound assessment app Patients will also be asked to score the average pain VAS and DN4 and itching at the wound site for the prior 2 weeks and to complete a 100 mm VAS of wound change where -100 is the wound is double in size 0- no change and 100 wound is completely closed Medical photographs of the target wounds will be taken
Blood sample 3 ml will be taken to measure cannabinoid level
The study participants completed phase II who are willing to take part in phase III will be able to participate if eligible after appropriate wash out period
Phase III will be a randomized placebo controlled blinded study Right versus Left side extremity assessing the efficacy and safety CBD cream in EB patients with acute and chronic wounds
30 EB patients with chronic orand acute wounds will participate in phase III Randomization and Blinding The name of each patient will be submitted to the research pharmacist He will prepare a randomization scheme and will allocate patients extremity to either placebo or CBD cream Families and patients as well as investigators will be blinded to the type of intervention throughout the duration of the study
The intervention is CBD 3 cream placebo The study medications will be dispensed as 100 g jars The study treatment will be applied to the entire or selected area of the extremity twice a day for 8 weeks a drawing will be provided to the patients and to the assessors for the purpose of consistency
The placebo will consist of a cream formulation with same color consistency and smell as the intervention which will be applied on the other extremity the application will mirror the process for the active medication
Both jars will be labeled appropriately with the location and dosage instructions
Allowable therapies Patients will continue the same skin care routine and dressings with the exceptions of use of topical corticosteroids and topical antibiotics Dressings that are impregnated with antimicrobials silver PHMB honey etc are allowed if previously used
Procedures For the purpose of this phase we will select 2 different patient populations A acute wounds group wounds that have been present for less than 4 weeks B chronic wounds group wounds that have been present for 4 weeks seen in patients with more severe types of EB
For patients who have more than one chronic wound in the selected extremity we will add the individual wounds surface areas
Visit 1 Screening Visit A screening form will be completed and patients who are willing to enroll and meet the inclusion criteria will be asked to sign the consentassent form by our study nurse Patients already on topical or systemic cannabinoids will be instructed to discontinue their treatment two weeks prior to the next visit Wash-out period
Visit 2 Baseline Visit
In addition to the demographic and clinical disease specific characteristics we will collect the following data
Blister count open and closed wound count evidence of infection dyspigmentation EB nevi
For patients with chronic wounds surface area wound characteristics wound swab for culture and sensitivity Current wound care regimen Pain score VAS and DN4 Itch score iscorEB clinician and patient EBQOL CBD level blood sample 3 ml
Visit 3 Mid study visit 4 weeks We will collect the same information as for baseline visit Visit 2 and additional data
VAS improvement patient Adverse events
Visit 4 End of study visit 8 weeks We will collect the same information as for previous visit Visit 3 plus - the CBD level in the blood will be measured again 3 ml sample
Wound swab will be taken group B if the study investigator deems it is necessary
Full study procedures phase II of the trial see below
Visit 1 Screening Visit A screening form will be completed and patients who are willing to enroll and meet the eligibility criteria will be asked to sign the consentassent form Patients already on cannabinoids will be instructed to discontinue their treatment two weeks prior to the next visit wash-out period Subjects who were not treated with antibiotics or corticosteroids in the previous 2 weeks for topical and 4 weeks for systemic agents will start the trial at this time
Visit 2 Baseline Visit A baseline data collection form will be completed We will select for the study treatment a chronic wound present for more than 4 weeks not measuring more than 1000 cm2 The surface area of the wound and quality of the wounds will be assessed and documented using the SWIFT medical wound assessment app a validated tool that allows serial estimates and measurements of the wound surface areas Bacterial swabs of selected target wound and medical photographs of the target wounds will be taken For the pain intensity assessment we will use a 100 mm visual analog scale VAS where 0 is no pain and 10- the worst pain ever experienced while the DN4 scale will be used for assessment of neuropathic pain For itch assessments we will ask patients to determine the degree of itching experienced that day using a 100 mm horizontal VAS for itch Patients will be provided with the study medication during this study visit and instructed to apply the cream twice a day for 4 weeks
Blood sample 3 ml will be taken to measure cannabinoid level in the blood Visit 3 End of study visit Patients will be assessed at 4 weeks when we will evaluate tolerability of the CBD oil and safety eg burning sensation pain itch local irritation systemic symptoms In addition we will calculate the surface area change from previous visit as well as the characteristics of the wounds using the SWIFT medical wound assessment app Patients will also be asked to score the average pain VAS and DN4 and itching at the wound site for the prior 2 weeks and to complete a 100 mm VAS of wound change where -100 is the wound is double in size 0- no change and 100 wound is completely closed Medical photographs of the target wounds will be taken
Blood sample 3 ml will be taken to measure cannabinoid level
The study participants completed phase II who are willing to take part in phase III will be able to participate if eligible after appropriate wash out period
Phase III will be a randomized placebo controlled blinded study Right versus Left side extremity assessing the efficacy and safety CBD cream in EB patients with acute and chronic wounds
30 EB patients with chronic orand acute wounds will participate in phase III Randomization and Blinding The name of each patient will be submitted to the research pharmacist He will prepare a randomization scheme and will allocate patients extremity to either placebo or CBD cream Families and patients as well as investigators will be blinded to the type of intervention throughout the duration of the study
The intervention is CBD 3 cream placebo The study medications will be dispensed as 100 g jars The study treatment will be applied to the entire or selected area of the extremity twice a day for 8 weeks a drawing will be provided to the patients and to the assessors for the purpose of consistency
The placebo will consist of a cream formulation with same color consistency and smell as the intervention which will be applied on the other extremity the application will mirror the process for the active medication
Both jars will be labeled appropriately with the location and dosage instructions
Allowable therapies Patients will continue the same skin care routine and dressings with the exceptions of use of topical corticosteroids and topical antibiotics Dressings that are impregnated with antimicrobials silver PHMB honey etc are allowed if previously used
Procedures For the purpose of this phase we will select 2 different patient populations A acute wounds group wounds that have been present for less than 4 weeks B chronic wounds group wounds that have been present for 4 weeks seen in patients with more severe types of EB
For patients who have more than one chronic wound in the selected extremity we will add the individual wounds surface areas
Visit 1 Screening Visit A screening form will be completed and patients who are willing to enroll and meet the inclusion criteria will be asked to sign the consentassent form by our study nurse Patients already on topical or systemic cannabinoids will be instructed to discontinue their treatment two weeks prior to the next visit Wash-out period
Visit 2 Baseline Visit
In addition to the demographic and clinical disease specific characteristics we will collect the following data
Blister count open and closed wound count evidence of infection dyspigmentation EB nevi
For patients with chronic wounds surface area wound characteristics wound swab for culture and sensitivity Current wound care regimen Pain score VAS and DN4 Itch score iscorEB clinician and patient EBQOL CBD level blood sample 3 ml
Visit 3 Mid study visit 4 weeks We will collect the same information as for baseline visit Visit 2 and additional data
VAS improvement patient Adverse events
Visit 4 End of study visit 8 weeks We will collect the same information as for previous visit Visit 3 plus - the CBD level in the blood will be measured again 3 ml sample
Wound swab will be taken group B if the study investigator deems it is necessary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None