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New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management

Sponsor
Dr. Stephanie Geisler (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05324202
Collaborator
(none)
50
Enrollment
1
Arm
7
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cynosure Cynergy Nd:YAG Laser 1064nm
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Nd:YAG treatment arm

Device: Cynosure Cynergy Nd:YAG Laser 1064nm
The Nd:YAG Laser 1064nm is intended to be used as a treatment option in individuals suffering from low-risk basal cell carcinoma(s).

Outcome Measures

Primary Outcome Measures

  1. Treatment efficacy of Nd:YAG Laser 1064-nm for low risk basal cell carcinomas [8 weeks after the treatment]

    Clearance rate of basal cell carcinomas after 1-3 Nd:YAG laser treatments evaluated by clinical inspectation, dermatosopy and optical coherence tomography.

  2. Recurrence Rate after Nd:YAG Laser treatment [12 months]

    To assess the recurrence rate after a long-term follow-up of 6 and 12 months

Secondary Outcome Measures

  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [6 and 12 months after treatment]

    To assess treatment tolerability of the Nd:YAG Laser 1064-nm (e.g. pain according to a Numerical rating scale, scarring, wound healing, secondary infection rate)

  2. Cosmetic outcome after laser treatment [6 and 12 months after treatment]

    This will be assess according to an assessment scale including following parameters: Pigmentation: hyperpigmentation, hypopigmentation, normal Vascularity: pink, red, purple, normal Pliability: firm, contracture, supple, yielding, ropes, normal Scarring: yes, no Overall opinion: Rating on a scale from 1-5 (school note system) Separate evaluation of observer and patient.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Dr. Stephanie Geisler

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Stephanie Geisler, Investigator, Resident in Dermatology, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT05324202
Other Study ID Numbers:
  • Ndyag_BCC_1
First Posted:
Apr 12, 2022
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell

Study Results

No Results Posted as of Apr 12, 2022