Treating Basal and Squamous Cell Carcinomas With Fractional Laser and Tirbanibulin Ointment
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBruce Robinson, MD
About this trial
The investigators seek to evaluate the effectiveness of fractional laser therapy and tirbanibulin ointment to treat squamous and basal cell carcinomas. This will be executed by using both thulium and erbium lasers on previously biopsy-confirmed SCCs and BCCs and applying bulk heating methods. Then, depending on the level of invasiveness, subjects may be instructed to apply the ointment over the course of five nights immediately following the treatment. The intention of this study is to minimize the need for invasive surgical procedures so as to optimize the cosmetic appearance, and provide a treatment option that is beneficial for a wide range of individuals.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Cannot be pregnant at the time of treatment
Trial design
Design model
Factorial
Treatments tested in this trial
Tirbanibulin ointment 1%
DrugTirbanibulin ointment is applied for 5 nights following the in-office fractional laser procedure for patients with more advanced carcinomas.
non-ablative fractional laser
DeviceEvery skin cancer will be treated with two wavelengths (1550nm and 1927nm) of a non-ablative fractional laser.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Fractional Laser OnlyActive comparator 1 intervention
Group B: Fractional Laser and Tirbanibulin OintmentActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Clearance of skin cancer by evidence of no clinical and/or histological recurrence after 5 years.
Participants will be monitored at 1 month post-procedure then biannually thereafter for 5 years. Site with be observed for clinical recurrence. Optional biopsy at each visit.
Time frame
From enrollment to the end of follow-up monitoring at 5 years.Secondary outcomes
1
Recurrence rate/Appearance/Patient Satisfaction as compared to accepted alternatives (Surgical excision, Mohs, Electrodesiccation and curettage)
Review the overall success of the treatment (recurrence and failure rates, appearance, patient satisfaction) compared to traditionally accepted alternative treatments including surgical excision, Mohs surgery, and Electrodesiccation and curettage
Time frame
Ongoing review from enrollment to the end of 5 year follow-up period & also a final review at the end of 5 years for all participants.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov