Basal Cell CarcinomaNCT04936932
Laser Treatment of Basal Cell Carcinoma
A study testing 1064 nm long-pulse Nd:YAG laser in people with Basal Cell Carcinoma, run by Sciton at 1 site in United States.
Trial summary
Laser treatment of Basal cell carcinoma Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- 1064 nm long-pulse Nd:YAG laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 20 Aug 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects 18 years of age or older
- Lesion is biopsy-proven superficial BCC <= 2.0 cm in largest diameter
- BCC is on trunk or extremities
- Seeks and is scheduled for treatment of BCC
- Willing to have photographs taken of the treatment area
- Ability to understand and the willingness to sign a written informed consent document
- Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions
Who cannot join
- Subjects with a BCC lesion that requires excision. This would include relatively larger lesions (>2.0 cm in diameter), high risk lesions as defined by American Academy of Dermatology as recurrent and sclerosing subtype BCC, or metastases.
- Pregnancy
- Subjects unable to follow-up for the full 12-months
- Subjects not willing to have biopsy taken from the treatment area
- Subjects with herpes simplex virus infection, impetigo or other disqualifying condition as determined by a dermatologist on the treatment area or effecting healing or outcome
Trial locations and contacts
1 site in 1 country.
About this study
Laser treatment of Basal cell carcinoma
Read the detailed description
The purpose of this pilot study is to examine the treatment of superficial basal cell carcinoma (BCC) with laser technology. The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a non-ablative laser already shown to effectively treat BCC.
- Conditions
- Basal Cell Carcinoma
- Being tested
- 1064 nm long-pulse Nd:YAG laser
- Keywords
- Superficial Basal Cell Carcinoma
- 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.
1064 nm long-pulse Nd:YAG laserDevice
BCC lesion will be treated with long-pulse 1064 laser
1064 nm long-pulse Nd:YAG laserDevice
BCC lesion will be treated with long-pulse 1064 laser
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | 1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec Receives: Device: 1064 nm long-pulse Nd:YAG laser |
| Slow | Active comparator | 1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec Receives: Device: 1064 nm long-pulse Nd:YAG laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clearance of BCC
Histological confirmation of BCC clearance. Biopsy will be taken from the treatment site to confirm complete BCC clearance
Measured: 1 year
Secondary outcomes (1)
Cosmetic outcome
Cosmetic outcome and any adverse effects of the laser treatment will be assessed
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Nov 2021
- Primary completion20 Aug 2022
- Study completion20 Aug 2022
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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sciton
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Robb, MD, Principal investigator, Skin & Allergy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936932
- Sponsor's protocol ID
- BCCCIP001
- Status last verified
- Dec 2022
- First submitted
- 21 Jun 2021
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Treatment of Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04936932
- Acronym / sponsor ID
- BCCCIP001
- Conditions
- Basal Cell Carcinoma
- Keywords
- Superficial Basal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- ScitonIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 23 Jun 2021 (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.
Laser treatment of Basal cell carcinoma
Detailed description
The purpose of this pilot study is to examine the treatment of superficial basal cell carcinoma (BCC) with laser technology. The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a non-ablative laser already shown to effectively treat BCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Device: 1064 nm long-pulse Nd:YAG laser1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec |
| Slow | Active comparator | Device: 1064 nm long-pulse Nd:YAG laser1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy subjects 18 years of age or older
- Lesion is biopsy-proven superficial BCC <= 2.0 cm in largest diameter
- BCC is on trunk or extremities
- Seeks and is scheduled for treatment of BCC
- Willing to have photographs taken of the treatment area
Key exclusion criteria (5 listed)
- Subjects with a BCC lesion that requires excision. This would include relatively larger lesions (>2.0 cm in diameter), high risk lesions as defined by American Academy of Dermatology as recurrent and sclerosing subtype BCC, or metastases.
- Pregnancy
- Subjects unable to follow-up for the full 12-months
- Subjects not willing to have biopsy taken from the treatment area
- Subjects with herpes simplex virus infection, impetigo or other disqualifying condition as determined by a dermatologist on the treatment area or effecting healing or outcome
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 |
|---|---|---|
| 1064 nm long-pulse Nd:YAG laserBCC lesion will be treated with long-pulse 1064 laser | Device | Standard |
| 1064 nm long-pulse Nd:YAG laserBCC lesion will be treated with long-pulse 1064 laser | Device | Slow |
Primary outcome
Complete clearance of BCC
Time frame: 1 year
Histological confirmation of BCC clearance. Biopsy will be taken from the treatment site to confirm complete BCC clearance
1 secondary outcome
Cosmetic outcome
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Chris Robb, MD principal investigator
Skin & Allergy Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1064 nm long-pulse Nd:YAG laser in people with Basal Cell Carcinoma, run by Sciton at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete clearance of BCC (time frame: 1 year). 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 8 Dec 2022.