NCT05257486

Post-market Multi-Center RETRO-Prospective Study to Assess Long-term Clinical Outcomes NMSC Patients Treated With eBx

Completed Results posted Last updated 13 January 2025

What this trial tests

trial testing Xoft eBx in Non-melanoma Skin Cancer in 183 participants. Completed in 13 October 2022.

Timeline

9 March 2022

Primary endpoint
18 July 2022

13 October 2022

Quick facts

Lead sponsor	Xoft, Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	183
Start date	9 March 2022
Primary completion	18 July 2022
Estimated completion	13 October 2022
Sites	2 locations across United States

Drugs / interventions tested

• Xoft eBx

Conditions studied

• Non-melanoma Skin Cancer — all drugs for Non-melanoma Skin Cancer →

Sponsor

Xoft, Inc.

Who can join

40 and older, any sex, with Non-melanoma Skin Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Local Recurrence Primary · Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion.

Physician office visit for long-term assessment to determine if recurrence of skin cancer has occurred at previously treated site for subjects who were previously treated at least 5 years prior; Subjects treated with Xoft eBx or MMS over 5 years prior were called in for a long-term prospective visit, reconsented, and assessed for skin cancer recurrence at the previously treated site.

Group	Value	95% CI
NMSC Treatment	2

Skin Toxicities Secondary · Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion.

Assessment of treatment site at a long-term follow-up visit conducted at 5 years or greater post treatment to determine if late toxicities have occurred at the previously treated site where either eBx or Mohs was performed. Subjects treated with Xoft eBx or MMS over 5 years prior were called in for a long-term prospective visit, reconsented, and assessed for late toxicities at the previously treated site.

Group	Value	95% CI
NMSC Treatment	129

Adverse events — posted to ClinicalTrials.gov

Time frame: Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

NMSC Treatment

Serious: 0/180 (0%)

Deaths: 0/180

Other adverse events (5 terms — click to expand)

Reaction	System	NMSC Treatment
Hypopigmentation Grade 1	Skin and subcutaneous tissue disorders	—
Telangiectasia Grade 1	Skin and subcutaneous tissue disorders	—
Scar Grade 1	Skin and subcutaneous tissue disorders	—
Hyperpigmentation Grade 1	Skin and subcutaneous tissue disorders	—
Induration Grade 2	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT05257486 adverse events section.

Sponsor's own description

The purpose of this retrospective-prospective study is to evaluate lesions after treatment for BCC or SCC NMSC in order to gain a better understanding of the durability of the treatment, and risk of late toxicities for this patient population.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.