CompletedPhase 2

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

France, Germany, Greece19 participantsStarted 2021-12-28

Plain-language summary

The purpose of this study is to evaluate the safety of INM-755 (cannabinol) cream and obtain preliminary evidence of efficacy in treating symptoms and healing wounds over a 28-day period in patients with epidermolysis bullosa (EB).

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. Have chronic itch with a score ≥40 mm on a 100 mm VAS
✓. Not exceed 20 percent of body surface area (BSA) or be less than 1 percent of BSA
✓. Be similar size, up to twice the area of the smaller index area
✓. Have a surface area ≥5 cm\^2 and ≤50 cm\^2 inclusive and be aged ≥3 weeks
✓. Be well matched for size (up to twice the area of the smaller index area) and age (both either ≥3 weeks to 3 months or \>3 months)

What they're measuring

Change from Baseline in Non-Wound Itch by Visual Analogue Scale (VAS)

Timeframe: Baseline to Day 29

Change from Baseline in Wound Surface Area

Timeframe: Baseline to Day 29

Change from Baseline in Procedural Wound Pain by VAS

Timeframe: Baseline to Day 29

Change from Baseline in Background Wound Pain by VAS

Timeframe: Baseline to Day 29

Change from Baseline in Wound Itch by VAS

Timeframe: Baseline to Day 29

Trial details

NCT IDNCT04908215

SponsorInMed Pharmaceuticals Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-03

View on ClinicalTrials.gov More Epidermolysis Bullosa Simplex trials