ClinicalTrials.gg
CompletedNCT04936932Updated Dec 8, 2022

Laser Treatment of Basal Cell Carcinoma

An interventional study of 1064 nm long-pulse Nd:YAG laser and 1064 nm long-pulse Nd:YAG laser in Basal Cell Carcinoma, sponsored by Sciton. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-08.

Sponsored by Sciton · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2022, 4 years 2 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Basal Cell Carcinoma

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Keywords

  • Superficial Basal Cell Carcinoma
03

In context

Carcinoma, Basal Cell

389 studies on the registry are indexed under Carcinoma, Basal Cell; 69 are open to participants now.

This study's enrollment of 3 is below the median of 50 across 272 interventional studies indexed under Carcinoma, Basal Cell.

Browse Carcinoma, Basal Cell studies →

Lead sponsor

Sciton is the lead sponsor of 15 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy subjects 18 years of age or older
  2. Lesion is -proven superficial BCC \<= 2.0 cm in largest diameter
  3. BCC is on trunk or extremities
  4. Seeks and is scheduled for treatment of BCC
  5. Willing to have photographs taken of the treatment area
  6. Ability to understand and the willingness to sign a written document
  7. Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions

Exclusion criteria

Exclusion Criteria:

  1. 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 .
  2. Pregnancy
  3. Subjects unable to follow-up for the full 12-months
  4. Subjects not willing to have taken from the treatment area
  5. 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Active comparator
    Standard

    1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec

    Device: 1064 nm long-pulse Nd:YAG laser

  • Active comparator
    Slow

    1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec

    Device: 1064 nm long-pulse Nd:YAG laser

Interventions

  • Device1064 nm long-pulse Nd:YAG laser

    BCC lesion will be treated with long-pulse 1064 laser

  • Device1064 nm long-pulse Nd:YAG laser

    BCC lesion will be treated with long-pulse 1064 laser

06

What researchers measure

Primary outcomes

  1. Complete clearance of BCC

    Histological confirmation of BCC clearance. Biopsy will be taken from the treatment site to confirm complete BCC clearance

    Time frame: 1 year

Secondary outcomes

  1. Cosmetic outcome

    Cosmetic outcome and any adverse effects of the laser treatment will be assessed

    Time frame: 1 year

07

Study locations

1 site
  • Skin & Allergy Center
    Spring Hill, Tennessee 37174, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Aug 2022, 9 months.

Of 50 interventional studies with no phase under Carcinoma, Basal Cell, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 64. This study's 9 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2021
First posted
Jun 23, 2021
StartActual
Nov 1, 2021
Primary completionActual
Aug 20, 2022
CompletionActual
Aug 20, 2022
Last update
Dec 8, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04936932
Lead sponsor
Sciton
Responsible party
Sponsor
First posted
Jun 23, 2021
Start date
Nov 1, 2021
Primary completion
Aug 20, 2022
Completion
Aug 20, 2022
Last update
Dec 8, 2022

Study contacts

Chris Robb, MD
principal investigator · Skin & Allergy Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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