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A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez

ConditionsEpidermolysis Bullosa, DystrophicEpidermolysis Bullosa, Junctional
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChiesi Farmaceutici S.p.A.

About this trial

In patients with epidermolysis bullosa (EB), collagen does not form properly, so their skin is very fragile and blisters easily. Such patients are also at greatly increased risk of developing skin cancers. Filsuvez is a topical gel used to promote healing of skin lesions in patients with certain types of EB. In this observational study, patients with either dystrophic EB (DEB) or junctional EB (JEB) will receive standard of care treatment, whether Filsuvez or something else, and will be followed for a minimum of 3 years. The main purpose is to see if the use of Filsuvez affects the likelihood of developing skin malignancies in these patient populations.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a confirmed diagnosis of dystrophic EB or junctional EB

Disqualifiers

None

Trial population

Patients with dystrophic EB or junctional EB, whether they are receiving Filsuvez, receiving another treatment for EB, or not receiving any treatment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Filsuvez

    Drug

    Topical gel

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Patients with dystrophic or junctional EB being treated with Filsuvez1 intervention
Group B: Patients with dystrophic or junctional EB not being treated with Filsuvez0 interventions

Trial outcomes

Primary outcomes

1

Incidence of first skin malignancy during follow-up in EB patients receiving Filsuvez

Patients being treated with Filsuvez will be followed for occurrence of skin malignancies from the date of study enrolment until either the date of discontinuation (withdrawal of consent, withdrawal from the site or registry, physician decision, death, or lost to follow-up) or termination of the study

Time frame
Minimum 3 years

Secondary outcomes

1

Incidence of first skin malignancy during follow-up in EB patients not receiving Filsuvez

Patients with EB who are not being treated with Filsuvez will be followed for occurrence of skin malignancies from the date of study enrolment until either the date of discontinuation (withdrawal of consent, withdrawal from the site or registry, physician decision, death, or lost to follow-up) or termination of the study

Time frame
Minimum 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chiesi Farmaceutici S.p.A.

Lead sponsor

Source ClinicalTrials.gov
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