Laser Treatment of Basal Cell Carcinoma
1 other identifier
interventional
3
1 country
1
Brief Summary
Laser treatment of Basal cell carcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2021
CompletedFirst Posted
Study publicly available on registry
June 23, 2021
CompletedStudy Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2022
CompletedDecember 8, 2022
December 1, 2022
10 months
June 21, 2021
December 6, 2022
Conditions
Keywords
Outcome Measures
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
1 year
Secondary Outcomes (1)
Cosmetic outcome
1 year
Study Arms (2)
Standard
ACTIVE COMPARATOR1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec
Slow
ACTIVE COMPARATOR1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scitonlead
Study Sites (1)
Skin & Allergy Center
Spring Hill, Tennessee, 37174, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chris Robb, MD
Skin & Allergy Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2021
First Posted
June 23, 2021
Study Start
November 1, 2021
Primary Completion
August 20, 2022
Study Completion
August 20, 2022
Last Updated
December 8, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share