Basal Cell CarcinomaNCT05324202
New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma Management
A study testing Cynosure Cynergy Nd:YAG Laser 1064nm in people with Basal Cell Carcinoma, run by Dr. Stephanie Geisler.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Cynosure Cynergy Nd:YAG Laser 1064nm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma
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.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Cynosure Cynergy Nd:YAG Laser 1064nm
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cynosure Cynergy Nd:YAG Laser 1064nmDevice
The Nd:YAG Laser 1064nm is intended to be used as a treatment option in individuals suffering from low-risk basal cell carcinoma(s).
| Study group | Role | What they receive |
|---|---|---|
| Nd:YAG treatment arm | Other | Not described Receives: Device: Cynosure Cynergy Nd:YAG Laser 1064nm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 months
Secondary outcomes (2)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
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)
Measured: 6 and 12 months after treatment
Cosmetic outcome after laser 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.
Measured: 6 and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Sep 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Stephanie Geisler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Stephanie Geisler, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324202
- Sponsor's protocol ID
- Ndyag_BCC_1
- Status last verified
- Apr 2022
- First submitted
- 5 Oct 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Imaging Procedures and Therapeutic Approach in Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05324202
- Acronym / sponsor ID
- Ndyag_BCC_1
- Conditions
- Basal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dr. Stephanie GeislerUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nd:YAG treatment arm | Other | Device: Cynosure Cynergy Nd:YAG Laser 1064nm |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cynosure Cynergy Nd:YAG Laser 1064nmThe Nd:YAG Laser 1064nm is intended to be used as a treatment option in individuals suffering from low-risk basal cell carcinoma(s). | Device | Nd:YAG treatment arm |
Primary outcome
Treatment efficacy of Nd:YAG Laser 1064-nm for low risk basal cell carcinomas
Time frame: 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
Time frame: 12 months
To assess the recurrence rate after a long-term follow-up of 6 and 12 months
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: 6 and 12 months after treatment
Cosmetic outcome after laser treatment
Time frame: 6 and 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cynosure Cynergy Nd:YAG Laser 1064nm in people with Basal Cell Carcinoma, run by Dr. Stephanie Geisler.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy of Nd:YAG Laser 1064-nm for low risk basal cell carcinomas (time frame: 8 weeks after the treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.