A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma.

A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma; primary outcome is success (no treatment failure or recurrence) at 3 years.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001083987

Acronym

SINS

Enrollment

500

Registered

2011-10-19

Start date

2003-06-19

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is an independent study (a randomised controlled trial) of imiquimod cream versus surgery in low risk basal cell carcinoma (or "rodent ulcer"). Basal cell carcinoma (BCC) is the commonest cancer in humans. BCCs are slow growing and rarely spread to other sites of the body, but can be unsightly and can bleed. They are usually treated by minor surgery (current “gold standard”) or freezing with liquid nitrogen, but dermatologists and plastic surgeons are constantly on the look-out for other simple but effective treatments. Imiquimod 5% cream stimulates the body's immune system and has been used successfully to treat genital warts, and more recently BCCs. This is a large definitive study comparing imiquimod to local surgery. Studies previous to this study were smaller, often looking just at initial success rather than whether the BCC returns in the long term. This study aims to show how effective imiquimod is in terms of percentage cure of basal cell carcinoma, three years after treatment, when compared with conventional surgery, and whether the cosmetic result of a cream that patients can apply themselves is any better than surgery.

Interventions

Imiquimod cream 5% applied 7 times per week (daily at night) for 6 weeks for superficial BCC and 12 weeks for nodular BCC. A thin layer was to be applied to the BCC and 1cm surrounding it, gently rubbed in until the cream vanished, and washed off the following morning.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

People with low risk superficial or nodular basal cell carcinoma (histologically proven basal cell carcinoma)

Exclusion criteria

Genetic/nevoid conditions e.g. Gorlin's syndrome. Morphoeic (microinfiltrative) trial lesion as diagnosed clinically. Allergy to any of the interventions. Involvement in a trial of another experimental intervention. Life threatening disease. Patients with bleeding disorders. Patients not available for follow up for 3 yrs. Pregnant, intention to become pregnant during treatment phase of the trial, or breastfeeding.

Outcome results