Basal Cell CarcinomaIMCXNCT01212562
Treatment of Primary Basal Cell Carcinomas of the Skin With Combination of Topical Imiquimod and Cryosurgery
An observational study of Basal Cell Carcinoma, run by University of Ioannina at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Immunocryosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2007to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with basal cell carcinoma
Who may be able to join
- Basal cell carcinoma of the skin
- Size < or = 2cm
- Number of tumors < or = 5
- Distance from eyelids, mouth >1cm
Who cannot join
- Size >2cm Number of tumors > 5 Distance from eyelids or mouth < or = 1cm
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department for Skin and Venereal Diseases, University Hospital
Ioannina, 45110
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Immunocryosurgery
- Keywords
- basal cell carcinoma, cryosurgery, imiquimod, immunocryosurgery
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunocryosurgeryProcedure or surgery
Also called Aldara
Assessing the efficacy of cryosurgery during continued imiquimod application (immunocrysurgery) in the treatment of basal cell carcinoma of the skin
| Study group | Role | What they receive |
|---|---|---|
| Immunocryosurgery | 2 weeks daily imiquimod application prior to a session of cryosurgery and subsequently 3 weeks continued daily imiquimod application Receives: Procedure: Immunocryosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of immunocryosurgery in the treatment of basal cell carcinoma of the skin
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.
Measured: 1 months
Secondary outcomes (1)
Feasibility and Tolerability of Immunocryosurgery
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startApr 2007
- Primary completionApr 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis Bassukas, University of Ioannina
- Investigators
- Ioannis D Bassukas, Professor, Principal investigator, Medical School, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212562
- Sponsor's protocol ID
- 75090409
- Acronym
- IMCX
- Status last verified
- Aug 2011
- First submitted
- 29 Sep 2010
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bassukas 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.
PubMed 19426725Bassukas 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.
PubMed 18412875Gaitanis 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.
PubMed 20814639Gaitanis 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.
PubMed 19555364Gaitanis 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.
PubMed 30219274
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01212562
- Acronym / sponsor ID
- IMCX / 75090409
- Conditions
- Basal Cell Carcinoma
- Keywords
- basal cell carcinoma, cryosurgery, imiquimod, immunocryosurgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 30 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunocryosurgery | – | Procedure: Immunocryosurgery2 weeks daily imiquimod application prior to a session of cryosurgery and subsequently 3 weeks continued daily imiquimod application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with basal cell carcinoma
Key inclusion criteria (4 listed)
- Basal cell carcinoma of the skin
- Size < or = 2cm
- Number of tumors < or = 5
- Distance from eyelids, mouth >1cm
Key exclusion criteria (1 listed)
- Size >2cm Number of tumors > 5 Distance from eyelids or mouth < or = 1cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunocryosurgeryAlso: AldaraAssessing the efficacy of cryosurgery during continued imiquimod application (immunocrysurgery) in the treatment of basal cell carcinoma of the skin | Procedure or surgery | Immunocryosurgery |
Primary outcome
Efficacy of immunocryosurgery in the treatment of basal cell carcinoma of the skin
Time frame: 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.
1 secondary outcome
Feasibility and Tolerability of Immunocryosurgery
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2011.
- Background: PubMed 19426725Bassukas 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.
- Background: PubMed 18412875Bassukas 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.
- Background: PubMed 20814639Gaitanis 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.
- Results publication: PubMed 19555364Gaitanis 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.
- Derived from this study: PubMed 30219274Gaitanis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioannis D Bassukas, Professor principal investigator
Medical School, University of Ioannina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma, run by University of Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of immunocryosurgery in the treatment of basal cell carcinoma of the skin (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01212562, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2011.