Carcinoma, Basal CellPhase 4ImiquimodNCT00803907
Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma
A Phase 4 study testing Imiquimod 5% cream in people with Carcinoma, Basal Cell, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study aimed to prove the efficacy and safety of the use of imiquimod 5% cream in the periorbital region. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carcinoma, Basal Cell
- What is being tested?
- Imiquimod 5% cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2008to Feb 2013
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients whose injuries were confirmed by anatomical and pathological study (periocular superficial basal cell carcinoma).
- Patients with clinical counter indication for reconstructive surgery (high surgical risk).
- Patients who have refused a restorative surgery. (aesthetic reasons)
- Patients who have signed the free and informed consent.
Who cannot join
- Patients who have a hypersensitivity reaction to the formula components.
- Children under 12 years of age.
- Pregnant and breastfeeding women.
- Patients whose injury was not confirmed by anatomical and pathological study.
- Individuals with previous autoimmune or inflammatory disease.
- Patients who have refused to sign the free and informed term of consent.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo
São Paulo, São Paulo
E M Macedo, 11-3069-7871, erickmarcet@yahoo.com.br
E M Macedo
About this study
This study aimed to prove the efficacy and safety of the use of imiquimod 5% cream in the periorbital region.
Read the detailed description
This is a prospective study including patients presenting in aggregate primary lesions affected by nodular BCC of the eyelid (all subjects were submitted to incisional biopsy at 2 mm punch) at the commencement of this study. All were submitted to a local treatment with Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average). All subjects were submitted to a new incisional biopsy at 2 mm punch, after 12 weeks of treatment, and all of them were monitored monthly up to now.If positive biopsy (residue tumor) cases will managed with surgery.
- Conditions
- Carcinoma, Basal Cell
- Being tested
- Imiquimod 5% cream
- Keywords
- immunomodulator, Carcinoma, Basal Cell
- 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.
Imiquimod 5% creamDrug
Also called immunomodulator
Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average)
| Study group | Role | What they receive |
|---|---|---|
| nodular BCC of the eyelid | Experimental | Patients with nodular BCC of the eyelid Receives: Drug: Imiquimod 5% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-treatment biopsy
Measured: post-treatment biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionSep 2012 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Basal CellStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erick Marcet Santiago de Macedo, University of Sao Paulo
- Investigators
- E M macedo, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803907
- Sponsor's protocol ID
- 0559/07
- Acronym
- Imiquimod
- Status last verified
- Jun 2012
- First submitted
- 3 Dec 2008
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
de Macedo EM, Carneiro RC, de Lima PP, Silva BG, Matayoshi S. Imiquimod cream efficacy in the treatment of periocular nodular basal cell carcinoma: a non-randomized trial. BMC Ophthalmol. 2015 Apr 3;15:35. doi: 10.1186/s12886-015-0024-0.
PubMed 25885553
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imiquimod 5% Cream for the Treatment of Periocular Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00803907
- Acronym / sponsor ID
- Imiquimod / 0559/07
- Conditions
- Carcinoma, Basal Cell
- Keywords
- immunomodulator, Carcinoma, Basal Cell
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 8 Dec 2008 (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.
This study aimed to prove the efficacy and safety of the use of imiquimod 5% cream in the periorbital region.
Detailed description
This is a prospective study including patients presenting in aggregate primary lesions affected by nodular BCC of the eyelid (all subjects were submitted to incisional biopsy at 2 mm punch) at the commencement of this study. All were submitted to a local treatment with Imiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average). All subjects were submitted to a new incisional biopsy at 2 mm punch, after 12 weeks of treatment, and all of them were monitored monthly up to now.If positive biopsy (residue tumor) cases will managed with surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nodular BCC of the eyelid | Experimental | Drug: Imiquimod 5% creamPatients with nodular BCC of the eyelid |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients whose injuries were confirmed by anatomical and pathological study (periocular superficial basal cell carcinoma).
- Patients with clinical counter indication for reconstructive surgery (high surgical risk).
- Patients who have refused a restorative surgery. (aesthetic reasons)
- Patients who have signed the free and informed consent.
Key exclusion criteria (6 listed)
- Patients who have a hypersensitivity reaction to the formula components.
- Children under 12 years of age.
- Pregnant and breastfeeding women.
- Patients whose injury was not confirmed by anatomical and pathological study.
- Individuals with previous autoimmune or inflammatory disease.
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 |
|---|---|---|
| Imiquimod 5% creamAlso: immunomodulatorImiquimod 5% cream (Aldara ®), once daily, 5 days per week for 8-16 weeks (average) | Drug | nodular BCC of the eyelid |
Primary outcome
post-treatment biopsy
Time frame: post-treatment biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2012.
- Derived from this study: PubMed 25885553de Macedo EM, Carneiro RC, de Lima PP, Silva BG, Matayoshi S. Imiquimod cream efficacy in the treatment of periocular nodular basal cell carcinoma: a non-randomized trial. BMC Ophthalmol. 2015 Apr 3;15:35. doi: 10.1186/s12886-015-0024-0.
Related trials for Carcinoma, Basal Cell
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients
Basal Cell Carcinoma (BCC), First Line Treatment
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)
Locally Advanced Basal Cell Carcinoma
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.
E M macedo principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Imiquimod 5% cream in people with Carcinoma, Basal Cell, run by University of Sao Paulo at 1 site in Brazil.
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 6 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: status not confirmed, as of the sponsor's last update on 13 Jun 2012. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erick Macedo (11-3069-7871, erickmarcet@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-treatment biopsy (time frame: post-treatment biopsy). 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 NCT00803907, which also lists 1 linked publication.
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 13 Jun 2012.