NCT04908215Phase 2Completed

INM-755 (Cannabinol) Cream for Treatment of Epidermolysis Bullosa

Study sponsor: InMed Pharmaceuticals Inc. · INM

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-04-03Actual

Enrollment · participants19Actual

Source updated2023-07-03Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Epidermolysis Bullosa Simplex; Epidermolysis Bullosa, Junctional; Epidermolysis Bullosa Dystrophica; Kindler Syndrome

Treatments or interventions studied

INM-755 (cannabinol) creamDrug
Vehicle CreamDrug

Primary outcomes · main study measures

Read the study measures

measure: Change from Baseline in Non-Wound Itch by Visual Analogue Scale (VAS); description: Patients will report peak (maximal) pruritus intensity over the previous 24 hours using a 100 mm VAS (0 being "no itch" to 100 mm being "worst imaginable itch") recorded daily in the study diary. This outcome measure is applicable only for patients with non-wound index areas with eligible (moderate to severe) itch.; timeFrame: Baseline to Day 29; measure: Change from Baseline in Wound Surface Area; description: Wound surface area will be measured by digital photography at weekly intervals. This outcome measure is applicable only for patients with wound index areas.; timeFrame: Baseline to Day 29; measure: Change from Baseline in Procedural Wound Pain by VAS; description: Patients will report wound pain intensity using a 100 mm VAS (0 being "no pain" to 100 mm being "worst imaginable pain") and this will be recorded in the study diary. Procedural pain will be assessed immediately after each wound dressing, which may be every 1, 2, or 3 days according to an individual patient's schedule for dressing change. This outcome measure is applicable only for patients with wound index areas associated with eligible (moderate to severe) procedural pain.; timeFrame: Baseline to Day 29; measure: Change from Baseline in Background Wound Pain by VAS; description: Patients will report wound pain intensity using a 100 mm VAS (0 being "no pain" to 100 mm being "worst imaginable pain") and this will be recorded in the study diary. Peak (maximal) background pain will be assessed daily in the morning (done before the dressing change). This outcome measure is applicable only for patients with wound index areas associated with eligible (moderate to severe) background pain.; timeFrame: Baseline to Day 29; measure: Change from Baseline in Wound Itch by VAS; description: Patients will report peak (maximal) pruritus intensity over the previous 24 hours using a 100 mm VAS (0 being "no itch" to 100 mm being "worst imaginable itch") recorded daily in the study diary. This outcome measure is applicable only for patients with wound index areas associated with eligible (moderate to severe) itch.; timeFrame: Baseline to Day 29

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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