SCIN (secondary analysis)
Trial question
Is superficial curettage plus imiquimod cream noninferior to surgical excision in patients with primary nodular basal cell carcinoma?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
47.0% female
53.0% male
N = 145
145 patients (68 female, 77 male).
Inclusion criteria: adult patients with primary nodular basal cell carcinoma (4-20 mm).
Key exclusion criteria: nodular basal cell carcinoma located in the H-zone of the face or hairy scalp; recurrent nodular basal cell carcinoma; aggressive basal cell carcinoma subtypes; life expectancy < 5 years; pregnancy or lactation; serious comorbidities; genetic skin cancer disorders; immunosuppressive medication during the trial period or within 30 days before enrolment.
Interventions
N=73 superficial curettage plus imiquimod (imiquimod cream 5% 5× per week, 6 weeks after curettage of the tumor tissue up to the adjacent skin).
N=72 surgical excision (surgical excision with 3 mm margin performed under local anesthesia into the subcutaneous fat).
Primary outcome
Freedom from treatment failure at 5 years
77.8%
98.2%
98.2 %
73.7 %
49.1 %
24.6 %
0.0 %
Superficial curettage plus
imiquimod
Surgical
excision
Difference exceeding
non-inferiority
margin ✗
Difference exceeding non-inferiority margin in freedom from treatment failure at 5 years (77.8% vs. 98.2%; HR 15.93, 95% CI 2.1 to 120.64).
Secondary outcomes
Significant increase in good or excellent 4-point scale (86.5% vs. 65.5%; AD 21%, 95% CI 5.02 to 36.98).
Significant decrease in mean Patient and Observer Scar Assessment Scale score overall opinion (observer 1) (2.2 points vs. 3.1 points; AD -0.9 points, 95% CI -1.66 to -0.14).
Significant decrease in mean Patient and Observer Scar Assessment Scale score overall opinion (observer 2) (2.2 points vs. 3.7 points; AD -1.5 points, 95% CI -2.45 to -0.55).
Conclusion
In adult patients with primary nodular basal cell carcinoma (4-20 mm), superficial curettage plus imiquimod was not noninferior to surgical excision with respect to freedom from treatment failure at 5 years.
Reference
Babette J A Verkouteren, Patty J Nelemans, Kelly A E Sinx et al. Imiquimod Cream Preceded by Superficial Curettage vs Surgical Excision for Nodular Basal Cell Carcinoma: A Secondary Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2025 Mar 1;161(3):299-304.
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