Treatment of Primary Basal Cell Carcinomas of the Skin With Combination of Topical Imiquimod and Cryosurgery

Open Label, Phase 3 Study of the Efficacy of Combination of Imiquimod and Cryosurgery in the Treatment of Primary Basal Cell Carcinomas of the Skin

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01212562

Acronym

IMCX

Enrollment

Registered

2010-09-30

Start date

2007-04-30

Completion date

2011-08-31

Last updated

2011-09-02

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

Conditions

Basal Cell Carcinoma

Keywords

basal cell carcinoma, cryosurgery, imiquimod, immunocryosurgery

Brief summary

The purpose of this study is to evaluate the efficacy of cryosurgery during continuing imiquimod application in the treatment of basal cell carcinoma of the skin.

Detailed description

Evaluation of efficacy: * Number of patient: N=50 * Inclusion criteria: Basal cell carcinoma of the skin proven with biopsy * Exclusion criteria: (1) Size of the tumors \>2cm; (2) Distance from the eyelid \<1cm; (3)Number of tumors \>5 Treatment protocol: Patients will apply imiquimod daily for 14 days on the tumor and a rim of 2mm around the tumor. On day 14 a session of mild cryosurgery (2 cycles of 10-15 seconds, with open spray liquid nitrogen) will be applied and the patients will continue application of imiquimod for another 3 weeks before being evaluated again. Persisting erosion will be considered as persistence of the tumor and imiquimod will be continued for another 3 weeks with/or without a cryosurgery session. The patients will be evaluated at 1,3,6,12 months after discontinuation of imiquimod and yearly thereafter for relapse. In case of clinical relapse, it will be confirmed by biopsy.

Interventions

PROCEDUREImmunocryosurgery

Assessing the efficacy of cryosurgery during continued imiquimod application (immunocrysurgery) in the treatment of basal cell carcinoma of the skin

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Basal cell carcinoma of the skin * Size \< or = 2cm * Number of tumors \< or = 5 * Distance from eyelids, mouth \>1cm

Exclusion criteria

* Size \>2cm Number of tumors \> 5 Distance from eyelids or mouth \< or = 1cm

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of immunocryosurgery in the treatment of basal cell carcinoma of the skin	1 months	Basal cell carcinomas of the skin will be treated with immunocryosurgery and the efficacy will be measured 1, 3, 6, and 12 months. Reappearance of the tumor within the primary lesion and 1cm around it will be considered as relapse.

Secondary

Measure	Time frame
Feasibility and Tolerability of Immunocryosurgery	1 month

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026