Superficial Basal Cell Carcinoma
Conditions
Brief summary
This is a prospective, randomized clinical trial conducted at the Unviersity of Wisconsin (UW) Dermatology Clinic located at 1 S. Park Street, Madison, WI 53715. There are no controls. Subjects meeting eligibility criteria are randomly divided into one of two treatment groups (ED&C x 1 cycle or ED&C x 3 cycles) using computer generated random numbers. One cycle of ED&C is defined according to standard technique currently employed. It involves scraping away the tumor with a curette (ring- shaped instrument) and then burning the curetted site with a small electric needle (electrodessication). During Visit 1, the surgical site is marked, local numbing medication is injected, and 1 or 3 cycles of ED&C is/are performed by board-certified dermatologists or a dermatology resident under the direct supervision of a board certified dermatologist. All follow-up visits (3, 6, 9, and 12 months after Visit 1) include skin evaluations by the physician who performed the ED&C. The lesion site is examined, measured, and photographed for clinical evidence of recurrence, as defined by a new lesion within the previously treated site. If there is evidence of possible tumor recurrence at the treated surgical site during Visit 2, 3, 4 or 5, then the lesion will be biopsied using a shave procedure.
Interventions
PROCEDUREElectrodessication & Curettage
Electrodessication & Curettage 1 or 3 cycles
Sponsors
Skin Cancer Foundation
Dermatology Foundation
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Untreated, biopsy proven superficial type basal cell carcinoma (BCC-S) on the trunk and/or extremities * Age greater than 21 * Women with childbearing potential (including those who are pregnant/lactating) * Able to provide written informed consent
Exclusion criteria
* Aggressive histology on initial biopsy (i.e. morpheaform, infiltrative, desmoplastic, or purely micronodular) * Prior history of BCC or other skin cancer at the same location * Lesion \> 2 cm * Patients with basal cell nevus syndrome * Transplant patients * Immunocompromised patients * Recurrent BCC * Greater than 2 BCC-S on the trunk and/or extremities * Prisoners * Allergy to lidocaine or epinephrine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C. | base line, every 3 months until 12 month completion | Clinical evidence of BCC recurrence post treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ED&C Times 3 Cycles Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles | 41 |
| ED & C Times 1 Cycle Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles | 44 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | study termination | 2 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | ED&C Times 3 Cycles | ED & C Times 1 Cycle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 12 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 32 Participants | 61 Participants |
| Region of Enrollment United States | 41 participants | 44 participants | 85 participants |
| Sex: Female, Male Female | 24 Participants | 20 Participants | 44 Participants |
| Sex: Female, Male Male | 17 Participants | 24 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 41 | 7 / 44 |
| serious Total, serious adverse events | 0 / 41 | 0 / 44 |
Outcome results
Primary
Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C.
Clinical evidence of BCC recurrence post treatment
Time frame: base line, every 3 months until 12 month completion
Population: Study was terminated early due to lack of funding and slow enrollment. Biostatisticians determined insufficient data was available for statistical significance. Primary/lead protocol author is no longer at the institution and no data analysis is intended. Study has been closed with the local IRB and study files archived.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ED&C Times 3 Cycles | Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C. | 1 participants |
| ED & C Times 1 Cycle | Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C. | 0 participants |