New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management

Not Applicable

• Conditions: Basal Cell Carcinoma

• Registration Number: NCT05324202
• Lead Sponsor: Dr. Stephanie Geisler

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-05
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-05
• Last Update Submitted: 2022-04-05
• Study First Posted: 2022-04-12
• Last Update Posted: 2022-04-12
• Study Start: 2022-09-01
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
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)
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.