Clinical trial · Observational
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
NCT01212562CI-TRIAL-00005447IMCXcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunocryosurgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Immunocryosurgery
- description
- 2 weeks daily imiquimod application prior to a session of cryosurgery and subsequently 3 weeks continued daily imiquimod application
- interventionNames
- Procedure: Immunocryosurgery
Primary outcomes (1)
- measure
- Efficacy of immunocryosurgery in the treatment of basal cell carcinoma of the skin
- timeFrame
- 1 months
- description
- 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 outcomes (1)
- measure
- Feasibility and Tolerability of Immunocryosurgery
- timeFrame
- 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDBassukas ID, Gaitanis G. Combination of cryosurgery and topical imiquimod: does timing matter for successful immunocryosurgery? Cryobiology. 2009 Aug;59(1):116-7. doi: 10.1016/j.cryobiol.2009.04.011. Epub 2009 May 6. No abstract available. PMID 19426725
- BACKGROUNDBassukas ID, Gamvroulia C, Zioga A, Nomikos K, Fotika C. Cryosurgery during topical imiquimod: a successful combination modality for lentigo maligna. Int J Dermatol. 2008 May;47(5):519-21. doi: 10.1111/j.1365-4632.2008.03562.x. PMID 18412875
- BACKGROUNDGaitanis G, Mitsou G, Tsiouri G, Alexis I, Bassukas ID. Cryosurgery during imiquimod cream treatment ("immunocryosurgery") for Bowen's disease of the skin: a case series. Acta Derm Venereol. 2010 Sep;90(5):533-4. doi: 10.2340/00015555-0896. No abstract available. PMID 20814639
- RESULTGaitanis G, Nomikos K, Vava E, Alexopoulos EC, Bassukas ID. Immunocryosurgery for basal cell carcinoma: results of a pilot, prospective, open-label study of cryosurgery during continued imiquimod application. J Eur Acad Dermatol Venereol. 2009 Dec;23(12):1427-31. doi: 10.1111/j.1468-3083.2009.03224.x. Epub 2009 Jun 25. PMID 19555364
- DERIVEDGaitanis G, Bassukas ID. Immunocryosurgery for non-superficial basal cell carcinomas </= 20 mm in maximal diameter: Five-year follow-up. J Geriatr Oncol. 2019 May;10(3):475-478. doi: 10.1016/j.jgo.2018.08.012. Epub 2018 Sep 12. PMID 30219274