Basal Cell CarcinomaPhase 4NCT00581425
Intron-A/Aldara Combination Therapy for Basal Cell Carcinoma (BCC)
A Phase 4 study testing Imiquimod and Interferon alpha in people with Basal Cell Carcinoma, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
A trial to see if BCC excluding the scalp and face can be treated successfully with a combination therapy of Intron-A and Aldara. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Imiquimod and Interferon alpha
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Sep 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Nodular or superficial basal cell carcinoma on the skin excluding scalp or face
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center of Houston Dermatology Clinic
Houston, Texas, 77030
About this study
Official title: Intron-A/Aldara Combination Therapy for BCC Excluding the Face and Scalp
A trial to see if BCC excluding the scalp and face can be treated successfully with a combination therapy of Intron-A and Aldara.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Imiquimod and Interferon alpha
- Keywords
- BCC, Basal Cell Carcinoma, Intron-A, Aldara, Basal Cell Carcinoma excluding scalp and face
- Medical subject headings
- Carcinoma, Basal Cell, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imiquimod and Interferon alphaBiological
Imiquimod first two weeks and last two weeks. Interferon middle five weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treated | Experimental | Not described Receives: Biological: Imiquimod and Interferon alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
resolution of basal cell carcinoma
Measured: 2 years
Secondary outcomes (1)
resolution of basal cell carcinoma at a lower cost and less inflammation.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionSep 2011
- Study completionSep 2011
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.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- 49 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Tucker, The University of Texas Health Science Center, Houston
- Investigators
- Stephen B Tucker, M.D., Principal investigator, University of Texas Health Science Center of Houston Dermatology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581425
- Sponsor's protocol ID
- HSC-MS-06-0478
- Other IDs
- OSP-24412
- Status last verified
- Jan 2013
- First submitted
- 21 Dec 2007
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intron-A/Aldara Combination Therapy for BCC Excluding the Face and Scalp
- ClinicalTrials.gov ID
- NCT00581425
- Acronym / sponsor ID
- HSC-MS-06-0478
- Conditions
- Basal Cell Carcinoma
- Keywords
- BCC, Basal Cell Carcinoma, Intron-A, Aldara, Basal Cell Carcinoma excluding scalp and face
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Dec 2007 (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.
A trial to see if BCC excluding the scalp and face can be treated successfully with a combination therapy of Intron-A and Aldara.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated | Experimental | Biological: Imiquimod and Interferon alpha |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Nodular or superficial basal cell carcinoma on the skin excluding scalp or face
Key exclusion criteria (1 listed)
- Pregnancy
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 and Interferon alphaImiquimod first two weeks and last two weeks. Interferon middle five weeks. | Biological | Treated |
Primary outcome
resolution of basal cell carcinoma
Time frame: 2 years
1 secondary outcome
resolution of basal cell carcinoma at a lower cost and less inflammation.
Time frame: 2 years
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 25 Jan 2013.
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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.
Stephen B Tucker, M.D. principal investigator
University of Texas Health Science Center of Houston Dermatology Clinic
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 and Interferon alpha in people with Basal Cell Carcinoma, run by The University of Texas Health Science Center, Houston 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 1 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 25 Jan 2013. 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?
resolution of basal cell carcinoma (time frame: 2 years). 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 25 Jan 2013.