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Outcome Measures

Primary Outcomes (5)

Change from Baseline in Non-Wound Itch by Visual Analogue Scale (VAS)
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.
Baseline to Day 29
Change from Baseline in Wound Surface Area
Wound surface area will be measured by digital photography at weekly intervals. This outcome measure is applicable only for patients with wound index areas.
Baseline to Day 29
Change from Baseline in Procedural Wound Pain by VAS
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.
Baseline to Day 29

Study Arms (2)

INM-755 (cannabinol) cream

EXPERIMENTAL

Cannabinol cream, topically applied daily in thin layer on non-wound index areas and every 1, 2 or 3 days in thick layer on dressings for index wounds for a 28-day period.

Drug: INM-755 (cannabinol) cream

Vehicle cream

PLACEBO COMPARATOR

Vehicle cream, topically applied daily in thin layer on non-wound index areas and every 1, 2 or 3 days in thick layer on dressings for index wounds for a 28-day period.

Drug: Vehicle Cream

Interventions

INM-755 (cannabinol) creamDrug

topical cream containing cannabinol for dermal application

INM-755 (cannabinol) cream

Vehicle CreamDrug

topical cream base for dermal application containing no active agent

Vehicle cream

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Male or female patients aged ≥18 years with documented diagnosis of any of the following types of inherited EB: Simplex, Junctional, Dystrophic, Kindler. Enrolment will be extended to patients ≥12 years old and \<18 years old after positive opinion of a data monitoring committee after at least 4 adult patients have completed study.

Study Sites (7)

Hopital Saint Louis APHP Paris

Paris, 75010, France

CHU Toulouse - Hopital Larrey

Toulouse, 31059, France

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79104, Germany

Andreas Syggros Hospital of Cutaneous Venereal Diseases

Athens, 16121, Greece

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423930, Israel

Fondazione IRCCS Ca Granda. Ospedale Maggiore Policlinico

Milan, Milano, 20122, Italy

Instituto Dermopatico dell'Immacolata, IDI-IRCCS

Rome, Roma, 00167, Italy

MeSH Terms

Conditions

Epidermolysis Bullosa SimplexEpidermolysis Bullosa, JunctionalEpidermolysis Bullosa DystrophicaPoikiloderma of Kindler

Interventions

Cannabinol

Condition Hierarchy (Ancestors)

Epidermolysis BullosaSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type

interventional

Phase

phase 2

Allocation

RANDOMIZED

Masking

QUADRUPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR

Masking Details

INM-755 (cannabinol cream) and vehicle cream (control) are identical in appearance and texture and packaged in kits labelled with unique blinded kit numbers.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Within-patient randomized, double-blind comparisons of INM-755 (cannabinol cream) versus vehicle cream (control) in matched, paired index areas

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Study Arms (2)

INM-755 (cannabinol) cream

Vehicle cream

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Study Arms (2)

INM-755 (cannabinol) cream

Vehicle cream

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations