Basal Cell CarcinomaPhase 4NCT00314756
Treatment of Nodular Basal Cell Carcinoma (BCC) With Imiquimod 5% Cream After Curettage
A Phase 4 study testing imiquimod in people with Basal Cell Carcinoma, run by Wake Forest University at 1 site in United States.
Trial summary
To assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after initial treatment with curettage Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- imiquimod
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Nov 2005
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are willing and able to give informed consent;
- Are at least 18 years of age;
- Are willing to comply with all study requirements, evaluations, and procedures
- Have 1 clinically typical, visible nodular BCC lesion which meets the following criteria:
- a primary lesion (not recurrent, not previously treated or biopsied)
- non-infected
Show all 14Show fewer
- size between 0.25 and 1.5 cm2
- located at least 1 cm from the eyes, nose, mouth, ear, and hairline to exclude the H-zone of the face
- clinically consistent with nodular BCC
- histologically consistent with nodular BCC and have no histological evidence of a morpheaform or micronodular pattern
- suitable for treatment with surgical excision
- easily identifiable and treatable by subject or reliable subject representative
- Are free of any significant physical abnormalities or previous scarring in the potential application site area that may cause difficulty with examinations.
- Are willing to stop using over-the-counter retinol products or products containing alpha or beta hydroxyacids in the treatment and surrounding area 8 hours prior to treatment with the imiquimod cream and clinic visits.
Who cannot join
- Have evidence of clinically significant, unstable, cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease that may interfere with completion of the study.
- Have any dermatological disease in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination.
- Have a BCC lesion located within 1 cm of the eyes, nose, mouth, ear, and hairline.
- Are pregnant at the screening or treatment initiation visit.
- Have known allergies to any excipient in the study cream
- Have undergone any surgical procedures in the potential treatment area within 4 weeks of the screening/treatment initiation visit. In addition, skin in the potential application area must be healed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Topical Imiquimod 5% Cream in the Treatment of Nodular Basal Cell Carcinoma After Initial Treatment With Curettage
To assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after initial treatment with curettage
Read the detailed description
The primary objective of this study is to evaluate the efficacy of imiquimod 5% cream on nodular BCC lesions treated 5x/week for 6 weeks after primary treatment with curettage without electrodesiccation. The secondary objective of this study is to evaluate the cosmetic outcome after treatment of the lesions using this modality.
- Conditions
- Basal Cell Carcinoma
- Being tested
- imiquimod
- Keywords
- imiquimod cream, nodular basal cell carcinoma, curettage
- 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.
imiquimodDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
histologic clearance of basal cell carcinoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2006 (estimated)
- Study startMar 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phillip M Williford, MD, Principal investigator, Wake Forest University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314756
- Sponsor's protocol ID
- BG04-484
- Status last verified
- Mar 2005
- First submitted
- 12 Apr 2006
- Last updated
- 22 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Imiquimod 5% Cream in the Treatment of Nodular Basal Cell Carcinoma After Initial Treatment With Curettage
- ClinicalTrials.gov ID
- NCT00314756
- Acronym / sponsor ID
- BG04-484
- Conditions
- Basal Cell Carcinoma
- Keywords
- imiquimod cream, nodular basal cell carcinoma, curettage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- Nov 2005
- First posted
- 14 Apr 2006 (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.
To assess the efficacy of treating a nodular basal cell carcinoma with imiquimod cream after initial treatment with curettage
Detailed description
The primary objective of this study is to evaluate the efficacy of imiquimod 5% cream on nodular BCC lesions treated 5x/week for 6 weeks after primary treatment with curettage without electrodesiccation. The secondary objective of this study is to evaluate the cosmetic outcome after treatment of the lesions using this modality.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Are willing and able to give informed consent;
- Are at least 18 years of age;
- Are willing to comply with all study requirements, evaluations, and procedures
- Have 1 clinically typical, visible nodular BCC lesion which meets the following criteria:
- Are free of any significant physical abnormalities or previous scarring in the potential application site area that may cause difficulty with examinations.
Key exclusion criteria (6 listed)
- Have evidence of clinically significant, unstable, cardiovascular or immunosuppressive, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or disease that may interfere with completion of the study.
- Have any dermatological disease in the treatment or surrounding area that may be exacerbated by treatment with imiquimod or cause difficulty with examination.
- Have a BCC lesion located within 1 cm of the eyes, nose, mouth, ear, and hairline.
- Are pregnant at the screening or treatment initiation visit.
- Have known allergies to any excipient in the study cream
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 | Drug | – |
Primary outcome
histologic clearance of basal cell carcinoma
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 22 Aug 2023.
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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.
Phillip M Williford, MD principal investigator
Wake Forest University Medical Center
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 in people with Basal Cell Carcinoma, run by Wake Forest University at 1 site in United States.
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 14 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: finished, as of the sponsor's last update on 22 Aug 2023. 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 United States. 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?
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?
histologic clearance of basal cell carcinoma. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2023.