New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
The aim of this study is to show that the Nd:YAG laser could be a promising alternative treatment option in the management of low-risk basal cell carcinomas with similar high efficacy rates to surgery, and low recurrence rates evaluated over a time period of one year. Reflectance confocal microscopy, optical coherence tomography and clinical examination are used prior to confirm the clinical diagnosis of the basal cell carcinoma and for premargination of the tumor. The optical coherence tomography will also be used post treatment to confirm clearance of the basal cell carcinoma and to monitor treatment response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2021
CompletedFirst Posted
Study publicly available on registry
April 12, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedApril 12, 2022
April 1, 2022
7 months
October 5, 2021
April 5, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Treatment efficacy of Nd:YAG Laser 1064-nm for low risk basal cell carcinomas
Clearance rate of basal cell carcinomas after 1-3 Nd:YAG laser treatments evaluated by clinical inspectation, dermatosopy and optical coherence tomography.
8 weeks after the treatment
Recurrence Rate after Nd:YAG Laser treatment
To assess the recurrence rate after a long-term follow-up of 6 and 12 months
12 months
Secondary Outcomes (2)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
6 and 12 months after treatment
Cosmetic outcome after laser treatment
6 and 12 months after treatment
Study Arms (1)
Nd:YAG treatment arm
OTHERInterventions
The Nd:YAG Laser 1064nm is intended to be used as a treatment option in individuals suffering from low-risk basal cell carcinoma(s).
Eligibility Criteria
You may qualify if:
- Patients with one or more basal cell carcinoma(s) on head, trunk or extremities
- Diagnosed clinically, with a dermatoscope and through noninvasive imaging methods such as reflectance confocal microscopy and optical coherence tomography
- H zone \<6mm, M zone \<10mm, L zone \<20mm
- Tumor thickness \<2mm
- Clearly visible margins
You may not qualify if:
- Pregnancy
- \<18 years of age
- Current or history of immunosuppression
- Prior-treatment of the basal cell carcinoma/ recurrent basal cell carcinomas
- History of radiation in the area of basal cell carcinoma appearance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Investigator, Resident in Dermatology
Study Record Dates
First Submitted
October 5, 2021
First Posted
April 12, 2022
Study Start
September 1, 2022
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
April 12, 2022
Record last verified: 2022-04