NCT04613102 is a Phase 2, PHASE3 clinical trial of AVCN583601 (3% Cannabidiol cream) in Epidermolysis Bullosa, sponsored by Elena Pope.

Who is sponsoring NCT04613102?

NCT04613102 is sponsored by Elena Pope.

What drugs are being tested in NCT04613102?

Interventions in NCT04613102: AVCN583601 (3% Cannabidiol cream).

What condition does NCT04613102 study?

NCT04613102 studies Epidermolysis Bullosa, Pain, Itch.

Is NCT04613102 still recruiting?

NCT04613102 is currently withdrawn. Last updated 18 June 2021.

Last reviewed 2021-06-18 · How we verify

NCT04613102

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Efficacy and Safety of 3% Cannabidiol (CBD) Cream in Patients With Epidermolysis Bullosa: A Phase II/III Trial

Withdrawn Phase 2, PHASE3 Last updated 18 June 2021

What this trial tests

Phase 2, PHASE3 trial testing AVCN583601 (3% Cannabidiol cream) in Epidermolysis Bullosa. Withdrawn.

Timeline

1 August 2020

Primary endpoint
1 September 2022

30 December 2022

Quick facts

Lead sponsor	Elena Pope
Phase	Phase 2, PHASE3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	treatment
Start date	1 August 2020
Primary completion	1 September 2022
Estimated completion	30 December 2022
Sites	1 location across Canada

Drugs / interventions tested

AVCN583601 (3% Cannabidiol cream) — full drug profile →

Conditions studied

Epidermolysis Bullosa — all drugs for Epidermolysis Bullosa →
Pain — all drugs for Pain →
Itch — all drugs for Itch →

Sponsor

Elena Pope — full company profile →

Who can join

Adults 4 to 50, any sex, with Epidermolysis Bullosa or Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The Regulatory Environment Surrounding Cannabis Medicines in the EU, the USA, and Australia.
Jardim C, Delgado-Charro MB. · · 2025 · cited 2× · PMID 40430926 · DOI 10.3390/pharmaceutics17050635

Verify or expand the search:

Other recruiting trials for Epidermolysis Bullosa

Currently open trials in the same condition.

NCT06330350 — Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling · recruiting
NCT05725018 — A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patien · Phase 3 · active not recruiting

Other Elena Pope trials

Trials by the same sponsor.

NCT02691117 — Topical Garlic Concentrate for Alopecia Areata in Children · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04613102 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Elena Pope
Last refreshed: 18 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04613102.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing