Photodynamic TherapyPhase 2NCT01349361
Treatment of Basal Cell Carcinomas With Methyl Aminolevulinate and Daylight
A Phase 2 study testing Daylight mediated photodynamic therapy in people with Photodynamic Therapy and Basal Cell Carcinomas, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Photodynamic Therapy (PDT) is an effective treatment of basal cell carcinomas (BCC) however the inconvenience of clinic attendance and discomfort during therapy are significant drawbacks. The objective of this study is to evaluate the effect of daylight-mediated PDT of BCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Photodynamic Therapy, Basal Cell Carcinomas
- What is being tested?
- Daylight mediated photodynamic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to Jan 2013
- Phase
- Phase 2
- 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
- Adult, Older adult
Who may be able to join
- superficial BCC
Who cannot join
- Immunosuppression
Trial locations and contacts
1 site in 1 country.
Stine R Wiegell, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen NV, 2400
Stine R Wiegell, MD, PhD, swie0001@bbh.regionh.dk
Stine R Wiegell, MD, PhD
About this study
Photodynamic Therapy (PDT) is an effective treatment of basal cell carcinomas (BCC) however the inconvenience of clinic attendance and discomfort during therapy are significant drawbacks. The objective of this study is to evaluate the effect of daylight-mediated PDT of BCC.
- Conditions
- Photodynamic Therapy, Basal Cell Carcinomas
- Being tested
- Daylight mediated photodynamic therapy
- 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.
Daylight mediated photodynamic therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Daylight-PDT | Experimental | Not described Receives: Procedure: Daylight mediated photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete disappearance of the BCC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photodynamic TherapyStudies 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 2
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349361
- Sponsor's protocol ID
- 2010-024517-31
- Status last verified
- Mar 2011
- First submitted
- 5 May 2011
- Last updated
- 6 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Basal Cell Carcinomas With Methyl Aminolevulinate and Daylight
- ClinicalTrials.gov ID
- NCT01349361
- Acronym / sponsor ID
- 2010-024517-31
- Conditions
- Photodynamic Therapy, Basal Cell Carcinomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2013
- First posted
- 6 May 2011 (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.
Photodynamic Therapy (PDT) is an effective treatment of basal cell carcinomas (BCC) however the inconvenience of clinic attendance and discomfort during therapy are significant drawbacks. The objective of this study is to evaluate the effect of daylight-mediated PDT of BCC.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daylight-PDT | Experimental | Procedure: Daylight mediated photodynamic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- superficial BCC
Key exclusion criteria (1 listed)
- Immunosuppression
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 |
|---|---|---|
| Daylight mediated photodynamic therapy | Procedure or surgery | Daylight-PDT |
Primary outcome
complete disappearance of the BCC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2011.
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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.
Stine R Wiegell, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daylight mediated photodynamic therapy in people with Photodynamic Therapy and Basal Cell Carcinomas, run by Bispebjerg Hospital at 1 site in Denmark.
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: status not confirmed, as of the sponsor's last update on 6 May 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 Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Stine R Wiegell, MD, PhD (swie0001@bbh.regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete disappearance of the BCC. 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 6 May 2011.