Nodular Basal Cell CarcinomaBCCNCT02270645
Randomized Pilot Study of Treatment for BCC Using the Multiplex 595/1064 nm Laser
A study testing 595/1064 multiplex laser in people with Nodular Basal Cell Carcinoma and Superficial Basal Cell Carcinoma, run by University of Miami at 1 site in United States.
Trial summary
Laser therapy for basal cell carcinoma may be a superior option for patients who do not wish to or cannot tolerate other treatment modalities such as topical chemotherapeutics or surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nodular Basal Cell Carcinoma, Superficial Basal Cell Carcinoma
- What is being tested?
- 595/1064 multiplex laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 years or older
- Diagnostic biopsy must be no later than three months prior to enrollment
- Lesion is biopsy-proven nodular or superficial BCC
- BCC is 1.5 cm or less in diameter
- BCC is on trunk or extremities
- Fitzpatrick skin types I, II, III, or IV
- If female, must no longer be of child-bearing potential
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- BCC is greater than 1.5 cm in size
- If location of BCC is on the face.
- Patients whose biopsy shows a subtype other than superficial or nodular, or has characteristics of a more aggressive nature, such as: Basosquamous basal cell carcinoma, Morpheaform/ infiltrative basal cell carcinoma, Sclerosing basal cell carcinoma, Recurrent basal cell carcinomas
- Patients who may not be able to tolerate light therapy, such as: Patients with seizure disorders triggered by light, Patients who have or are currently receiving gold therapy, Patients with any light sensitive disorder, Patients taking medication that increases sensitivity to light, Patients with Systemic Lupus Erythematous
- Fitzpatrick skin types V or VI
- Patients who are taking certain oral medications such as: Anticoagulants except for aspirin 81 mg, Isotretinoin (currently or within last 6 months), Medications that alter wound healing
- Patients who have a history of Herpes Simplex Virus outbreak in the area to be treated
- Patients whose lesion has been previously, or is currently being, treated by another modality (topical immunomodulators/ chemotherapeutics, cryotherapy, curettage and electrodesiccation, surgical excision, or Mohs micrographic surgery)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
About this study
Official title: Randomized Pilot Study of Treatment for Basal Cell Carcinoma Using the Multiplex 595/1064 nm Laser
Laser therapy for basal cell carcinoma may be a superior option for patients who do not wish to or cannot tolerate other treatment modalities such as topical chemotherapeutics or surgery.
In this pilot study, we will preliminarily assess the efficacy and safety of the 595/1064 nm Multiplex laser when treating superficial and nodular basal cell carcinomas less than 1.5 cm in size. This is an unblinded study in which patients will be randomized to either a treatment arm or a control arm. Patients in the treatment arm will receive three treatments with the 595/1064 nm multiplex laser spaced four weeks apart. The control group will visit the clinic with the same schedule as the treatment group for monitoring of the lesion. All patients will return one month after last treatment session or clinical visit, for evaluation of clinical and histological clearance.
Read the detailed description
Basal cell carcinoma is a malignancy with significant prevalence that rarely metastasizes but can be locally destructive. Laser therapy for this type of lesion may be a superior option for patients who do not wish to or cannot tolerate other modalities such as topical chemotherapeutics or surgery.
In this pilot study, we will preliminarily assess the efficacy and safety of the 595/1064 nm Multiplex laser when treating superficial and nodular basal cell carcinomas less than 1.5 cm in size. Eligible patients with biopsy-proven superficial or nodular BCCs less than 1.5 cm in size will have the opportunity to enroll in this study. This is an unblinded study in which patients will be randomized to either a treatment arm or a control arm. Patients in the treatment arm will receive three treatments with the 595/1064 nm multiplex laser spaced four weeks apart. In addition to assessing the presence of any adverse effects, photographs will be taken at each visit. One month after the last treatment session, patients in this group will return for evaluation of 1) clinical clearance and 2) histological clearance of their BCC. In order to assess clinical clearance, a dermatologist will grossly examine, measure, and document any residual lesion. Afterwards, a deep excisional biopsy encompassing the entire region will be taken and histological clearance will be determined by a microscopic examination for any residual tumor cells. Follow-up for wound care of the biopsy will occur one week later. Tumor burden will be calculated by change in surface area of the lesion.
After standard diagnostic biopsy, patients in the control arm will be followed for three regular visits, spaced 4 weeks apart. One month after the third follow-up visit, control patients will return for final photography and evaluation of clinical and histological clearance, just as the treatment arm. Although extremely rare1, if any clinical signs of progression are visible during this period (what we will consider greater than 10% growth), the patient will be withdrawn from the study and will undergo standard of care treatment.
- Being tested
- 595/1064 multiplex laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
595/1064 multiplex laserDevice
595/1064 multiplex laser will be used 3 times spaced by a four week interval (+/- 3 days), it will be administered in an outpatient clinic setting.
| Study group | Role | What they receive |
|---|---|---|
| Treatment: 595/1064 multiplex laser | Experimental | Subjects in the treatment arm will receive 3 treatments using the 595/1064 multiplex laser spaced by a four week interval (+/- 3 days), administered in an outpatient clinic setting. If a subject in the treatment arm has multiple BCCs satisfying inclusion criteria, all BCCs will be treated.
Four weeks (+/- 3 days) after the last treatment (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist.
Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment. Receives: Device: 595/1064 multiplex laser |
| Control | No intervention | Subjects in the control arm will receive 3 regular study visits spaced 4 weeks (+/- 3 days) apart. If a subject in the control arm has multiple BCCs satisfying inclusion criteria, all BCCs will not be treated. Four weeks (+/- 3 days) after the last (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist. Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Lesions Cleared Histologically
Number of lesions cleared clinically and histologically. The lesion clearance was determined by measuring the size of lesion which also included a histological evaluation 4 weeks after the treatment.
Measured: 91 days
Secondary outcomes (1)
Number of Adverse Events Reported
Adverse events reported by participants
Measured: 91 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nodular 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keyvan Nouri, University of Miami
- Investigators
- Keyvan Nouri, MD, Principal investigator, University of Miami Silvester Comprenhensive Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270645
- Sponsor's protocol ID
- 20120815
- Acronym
- BCC
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2014
- Last updated
- 2 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Study of Treatment for Basal Cell Carcinoma Using the Multiplex 595/1064 nm Laser
- ClinicalTrials.gov ID
- NCT02270645
- Acronym / sponsor ID
- BCC / 20120815
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Posted 2 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laser therapy for basal cell carcinoma may be a superior option for patients who do not wish to or cannot tolerate other treatment modalities such as topical chemotherapeutics or surgery.
In this pilot study, we will preliminarily assess the efficacy and safety of the 595/1064 nm Multiplex laser when treating superficial and nodular basal cell carcinomas less than 1.5 cm in size. This is an unblinded study in which patients will be randomized to either a treatment arm or a control arm. Patients in the treatment arm will receive three treatments with the 595/1064 nm multiplex laser spaced four weeks apart. The control group will visit the clinic with the same schedule as the treatment group for monitoring of the lesion. All patients will return one month after last treatment session or clinical visit, for evaluation of clinical and histological clearance.
Detailed description
Basal cell carcinoma is a malignancy with significant prevalence that rarely metastasizes but can be locally destructive. Laser therapy for this type of lesion may be a superior option for patients who do not wish to or cannot tolerate other modalities such as topical chemotherapeutics or surgery.
In this pilot study, we will preliminarily assess the efficacy and safety of the 595/1064 nm Multiplex laser when treating superficial and nodular basal cell carcinomas less than 1.5 cm in size. Eligible patients with biopsy-proven superficial or nodular BCCs less than 1.5 cm in size will have the opportunity to enroll in this study. This is an unblinded study in which patients will be randomized to either a treatment arm or a control arm. Patients in the treatment arm will receive three treatments with the 595/1064 nm multiplex laser spaced four weeks apart. In addition to assessing the presence of any adverse effects, photographs will be taken at each visit. One month after the last treatment session, patients in this group will return for evaluation of 1) clinical clearance and 2) histological clearance of their BCC. In order to assess clinical clearance, a dermatologist will grossly examine, measure, and document any residual lesion. Afterwards, a deep excisional biopsy encompassing the entire region will be taken and histological clearance will be determined by a microscopic examination for any residual tumor cells. Follow-up for wound care of the biopsy will occur one week later. Tumor burden will be calculated by change in surface area of the lesion.
After standard diagnostic biopsy, patients in the control arm will be followed for three regular visits, spaced 4 weeks apart. One month after the third follow-up visit, control patients will return for final photography and evaluation of clinical and histological clearance, just as the treatment arm. Although extremely rare1, if any clinical signs of progression are visible during this period (what we will consider greater than 10% growth), the patient will be withdrawn from the study and will undergo standard of care treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment: 595/1064 multiplex laser | Experimental | Device: 595/1064 multiplex laserSubjects in the treatment arm will receive 3 treatments using the 595/1064 multiplex laser spaced by a four week interval (+/- 3 days), administered in an outpatient clinic setting. If a subject in the treatment arm has multiple BCCs satisfying inclusion criteria, all BCCs will be treated. Four weeks (+/- 3 days) after the last treatment (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist. Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment. |
| Control | No intervention | –Subjects in the control arm will receive 3 regular study visits spaced 4 weeks (+/- 3 days) apart. If a subject in the control arm has multiple BCCs satisfying inclusion criteria, all BCCs will not be treated. Four weeks (+/- 3 days) after the last (Day 84) both treatment and control patients will be assessed for final clinical appearance, measurement, and evaluation of the lesion by a dermatologist. Subjects will also undergo deep excisional biopsy encompassing the entire lesion to determine residual tumor cell presence. If histologic examination of the tissue reveals residual BCC, then the subject will receive standard of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults age 18 years or older
- Diagnostic biopsy must be no later than three months prior to enrollment
- Lesion is biopsy-proven nodular or superficial BCC
- BCC is 1.5 cm or less in diameter
- BCC is on trunk or extremities
Key exclusion criteria (8 listed)
- BCC is greater than 1.5 cm in size
- If location of BCC is on the face.
- Patients whose biopsy shows a subtype other than superficial or nodular, or has characteristics of a more aggressive nature, such as: Basosquamous basal cell carcinoma, Morpheaform/ infiltrative basal cell carcinoma, Sclerosing basal cell carcinoma, Recurrent basal cell carcinomas
- Patients who may not be able to tolerate light therapy, such as: Patients with seizure disorders triggered by light, Patients who have or are currently receiving gold therapy, Patients with any light sensitive disorder, Patients taking medication that increases sensitivity to light, Patients with Systemic Lupus Erythematous
- Fitzpatrick skin types V or VI
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 |
|---|---|---|
| 595/1064 multiplex laser595/1064 multiplex laser will be used 3 times spaced by a four week interval (+/- 3 days), it will be administered in an outpatient clinic setting. | Device | Treatment: 595/1064 multiplex laser |
Primary outcome
Percentage of Lesions Cleared Histologically
Time frame: 91 days
Number of lesions cleared clinically and histologically. The lesion clearance was determined by measuring the size of lesion which also included a histological evaluation 4 weeks after the treatment.
1 secondary outcome
Number of Adverse Events Reported
Time frame: 91 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Study of Intralesional FLD-103 in Subjects With Basal Cell Carcinoma (BCC)
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High Intensity Focused Ultrasound vs. Cryotherapy in the Treatment of Basal Cell Carcinomas and Bowen's Disease in Adults
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Photodynamic Therapy Associated With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma
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A Study to Evaluate the Safety and Efficacy of EscharEx (EX-02) in the Treatment of Basal Cell Carcinoma
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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.
Keyvan Nouri, MD principal investigator
University of Miami Silvester Comprenhensive Care 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 595/1064 multiplex laser in people with Nodular Basal Cell Carcinoma and Superficial Basal Cell Carcinoma, run by University of Miami 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 8 inclusion and 8 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 2 Oct 2018. 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?
Yes. Results are posted in the registry (first posted 2 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Lesions Cleared Histologically (time frame: 91 days). 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 2 Oct 2018.