New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management

D

Dr. Stephanie Geisler

Status

Not yet enrolling

Conditions

Basal Cell Carcinoma

Treatments

Device: Cynosure Cynergy Nd:YAG Laser 1064nm

Study type

Interventional

Funder types

Other

Identifiers

NCT05324202
Ndyag_BCC_1

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Nd:YAG treatment arm
Other group
Treatment:
Device: Cynosure Cynergy Nd:YAG Laser 1064nm

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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