Basal Cell CarcinomaNCT02125669
Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas
A study testing Laser treatment in people with Basal Cell Carcinoma, run by Hautklinik Darmstadt.
Trial summary
Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic approach for treating basal cell carcinomas. Robust supporting evidence is, however, lacking due to inconsistent design of available studies. 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?
- Laser treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Sep 2013
- Phase
- Interventional
- 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
Who may be able to join
- histologically confirmed unpigmented sBCC on the trunk and extremities
- maximal tumour diameter 30 mm
Who cannot join
- Fitzpatrick skin type >III
- pregnancy
- previous BCC treatment within 4 weeks
- coagulation disorders
- photo sensitizing medication
- any indication of poor compliance
About this study
Official title: The Role of the 595 nm Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas at Low Risk Anatomical Sites: Outcome of a Double Blind Randomized Placebo Controlled Trial
Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic approach for treating basal cell carcinomas. Robust supporting evidence is, however, lacking due to inconsistent design of available studies. The purpose of this study is to evaluate the PDL's efficacy and safety in treating superficial basal cell carcinoma (sBCC) at low risk anatomical sites in an evidence based study setting.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Laser treatment, SHAM-Treatment
- Keywords
- basal cell carcinoma, laser surgery, pulsed dye laser, randomized controlled trial
- 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.
Laser treatmentProcedure or surgery
Pulsed dye laser 595nm
SHAM-TreatmentDevice
using the pulsed dye laser (PDL) laser without releasing a pulse
| Study group | Role | What they receive |
|---|---|---|
| Laser Treatment | Active comparator | Pulsed dye laser 595nm Receives: Procedure: Laser treatment |
| SHAM Treatment | Sham comparator | using the pulsed dye laser (PDL) laser without releasing a pulse Receives: Device: SHAM-Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response
Measured: 9 months
Secondary outcomes (3)
patients satisfaction
questionnaire
Measured: 9 months
side effects
questionnaire
Measured: 9 months
reduction of tumor diameter and tumor thickness
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionSep 2013
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hautklinik Darmstadt
- Sponsor type
- University, hospital or other
- Collaborators
- University Medicine Greifswald
- Responsible party
- Principal investigator, Maurizio Podda, Hautklinik Darmstadt
- Investigators
- Maurizio Podda, Dr., Principal investigator, Hautklinik DarmstadtSyrus Karsai, Dr., Study director, Hautklinik DarmstadtHeiko Friedl, Study chair, Hautklinik Darmstadt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125669
- Sponsor's protocol ID
- FF57/2012
- Status last verified
- Apr 2014
- First submitted
- 13 Apr 2014
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the 595 nm Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas at Low Risk Anatomical Sites: Outcome of a Double Blind Randomized Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02125669
- Acronym / sponsor ID
- FF57/2012
- Conditions
- Basal Cell Carcinoma
- Keywords
- basal cell carcinoma, laser surgery, pulsed dye laser, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hautklinik DarmstadtUniversity, hospital or other
- Collaborators
- University Medicine Greifswald
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 29 Apr 2014 (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.
Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic approach for treating basal cell carcinomas. Robust supporting evidence is, however, lacking due to inconsistent design of available studies. The purpose of this study is to evaluate the PDL's efficacy and safety in treating superficial basal cell carcinoma (sBCC) at low risk anatomical sites in an evidence based study setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Treatment | Active comparator | Procedure: Laser treatmentPulsed dye laser 595nm |
| SHAM Treatment | Sham comparator | Device: SHAM-Treatmentusing the pulsed dye laser (PDL) laser without releasing a pulse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- histologically confirmed unpigmented sBCC on the trunk and extremities
- maximal tumour diameter 30 mm
Key exclusion criteria (6 listed)
- Fitzpatrick skin type >III
- pregnancy
- previous BCC treatment within 4 weeks
- coagulation disorders
- photo sensitizing medication
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 |
|---|---|---|
| Laser treatmentPulsed dye laser 595nm | Procedure or surgery | Laser Treatment |
| SHAM-Treatmentusing the pulsed dye laser (PDL) laser without releasing a pulse | Device | SHAM Treatment |
Primary outcome
complete response
Time frame: 9 months
3 secondary outcomes
patients satisfaction
Time frame: 9 months
side effects
Time frame: 9 months
reduction of tumor diameter and tumor thickness
Time frame: 9 months
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 29 Apr 2014.
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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.
Maurizio Podda, Dr. principal investigator
Hautklinik Darmstadt
Syrus Karsai, Dr. study director
Hautklinik Darmstadt
Heiko Friedl study chair
Hautklinik Darmstadt
Questions about this trial
What is this clinical trial studying?
A study testing Laser treatment in people with Basal Cell Carcinoma, run by Hautklinik Darmstadt.
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 2 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 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
complete response (time frame: 9 months). 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 29 Apr 2014.