Randomized Pilot Study of Treatment for BCC Using the Multiplex 595/1064 nm Laser

NCT02270645 | Completed Results DMC

• 1 other identifier: 20120815
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nodular Basal Cell Carcinoma; Superficial Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  91 days

Secondary Outcomes (1)

• Number of Adverse Events Reported

  91 days

Study Arms (2)

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.

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.

Interventions

595/1064 multiplex laser DEVICE

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.

Treatment: 595/1064 multiplex laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Results Point of Contact

• Title: Keyvan Nouri
• Organization: University of Miami

knouri@med.miami.edu

3052433380

Study Officials

• Keyvan Nouri, MD

  University of Miami Silvester Comprenhensive Care Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 21, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 2, 2018
• Results First Posted: October 2, 2018

Record last verified: 2018-10

Locations

US (1)