Basal Cell Carcinoma
Conditions
Keywords
BCC curettage
Brief summary
The primary objective of this study is to assess whether basal cell carcinoma (BCC) lesions surgically treated with curettage, followed by imiquimod 5% cream as postsurgical adjuvant therapy, will have an improved cure rate over the ED/C historical norm of approximately 70% at 1-year posttreatment follow-up. A secondary objective is to assess cosmetic outcome.
Detailed description
This was an open-label, phase IIIb, multicenter, single arm, historical-controlled study. Biopsy-confirmed BCC lesions (1 per subject) were excised by curettage, with no electrodessication. Approximately 1 week later, treatment with imiquimod 5% cream was initiated. Imiquimod was applied to the target BCC once daily, 5 times per week (5x/week) for up to 6 weeks. Rest periods were allowed as needed. Subjects reported to the study center at treatment weeks 1, 2, and 6, and posttreatment at weeks 12, 26, and 52. At treatment week 6 and all posttreatment visits, the investigator clinically assessed the target site for tumor clearance and cosmetic outcome. A template made at initiation and created from clear plastic overlay aided in locating the target tumor site. If the investigator identified a lesion that had occurred or recurred at the target site, the subject was discontinued from the study and counted as a recurrence/persistence (R/P).
Interventions
Imiquimod 5% cream applied once daily 5x/week for up to 6 weeks
Sponsors
Graceway Pharmaceuticals, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Basal cell carcinoma
Exclusion criteria
* Psoriasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with recurrence | 1 year posttreatment | Primary variable was the proportion of subjects with recurrence/persistence (R/P)of BCC at 1 year posttreatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic outcome of the target lesion | 1 year posttreatment | The cosmetic outcome of the target lesion at 1 year posttreatment was the secondary efficacy measurement. The investigator judged cosmetic outcome by using a visual analog scale (VAS) to assess the parameters of hypo- and hyperpigmentation,roughness, scarring, and overall skin health and appearance. |
Countries
United States
Outcome results
None listed