Basal Cell CarcinomaPhase 1NCT00985829
Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma
A Phase 1 study testing photodynamic therapy in people with Basal Cell Carcinoma, run by Shahid Beheshti University of Medical Sciences.
Trial summary
The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors that affect response rate. 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?
- photodynamic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Mar 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 proven BCCs
Who cannot join
- rodent ulcer
- morphea type
- ANA +
- history of photosensitivity or photodermatosis or ingestion of phototoxic drugs during last month
- pregnancy
- breast feeding
- age< 18
- history of another therapeutic intervention for bcc during last 6 months
About this study
The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors that affect response rate.
Read the detailed description
Background and Aim: Basal cell carcinoma (BCC) is the most common skin cancer .Photodynamic therapy _as a novel , non-invasive therapeutic approach _may be considered a valuable strategy. This study was designed with the aim of the evaluation of efficacy of PDT in treatment of BCC and factors that may affect response rate.
Materials and Methods: This was a clinical trial which was done on 28 BCCs. Patients were treated with ALA-PDT monthly for 1-6 sessions and evaluated for clinical response,cosmetic results and probable side effects.
- Conditions
- Basal Cell Carcinoma
- Being tested
- photodynamic therapy
- Keywords
- basal cell carcinoma, photodynamic therapy, photo chemotherapy, basal cell epithelioma
- 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.
photodynamic therapyRadiation
Also called PDT 1200L Waldman Medizintechnik; Schwenningen, Germany
treatment of bcc with 5_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly
| Study group | Role | What they receive |
|---|---|---|
| BCC, ALA-PDT | Experimental | Patients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT Receives: Radiation: photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response to Photodynamic Therapy
categorized in 3 groups: complete response: there was no visible or palpable lesion; partial response: there was a visible or palpable lesion but the diameter of the lesion had reduced; no response: there was a visible or palpable lesion and the diameter of the lesion had not reduced
Measured: immediately after termination of treatment course (with an average of 5 month after initiation of PDT)
Secondary outcomes (1)
Histologic Resolution of Lesion
disappearance of the lesion in histologic examination
Measured: immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startJan 2008
- Primary completionJul 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Zohreh Tehranchi-nia, assist.prof., Principal investigator, Skin Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985829
- Sponsor's protocol ID
- pdt bcc1
- Other IDs
- NCT00985829
- Status last verified
- Nov 2009
- First submitted
- 26 Sep 2009
- Last updated
- 22 Dec 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00985829
- Acronym / sponsor ID
- pdt bcc1
- Conditions
- Basal Cell Carcinoma
- Keywords
- basal cell carcinoma, photodynamic therapy, photo chemotherapy, basal cell epithelioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 28 Sep 2009 (estimated)
- Results
- Posted 22 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors that affect response rate.
Detailed description
Background and Aim: Basal cell carcinoma (BCC) is the most common skin cancer .Photodynamic therapy _as a novel , non-invasive therapeutic approach _may be considered a valuable strategy. This study was designed with the aim of the evaluation of efficacy of PDT in treatment of BCC and factors that may affect response rate.
Materials and Methods: This was a clinical trial which was done on 28 BCCs. Patients were treated with ALA-PDT monthly for 1-6 sessions and evaluated for clinical response,cosmetic results and probable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCC, ALA-PDT | Experimental | Radiation: photodynamic therapyPatients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically proven BCCs
Key exclusion criteria (8 listed)
- rodent ulcer
- morphea type
- ANA +
- history of photosensitivity or photodermatosis or ingestion of phototoxic drugs during last month
- 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 |
|---|---|---|
| photodynamic therapyAlso: PDT 1200L Waldman Medizintechnik; Schwenningen, Germanytreatment of bcc with 5_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly | Radiation | BCC, ALA-PDT |
Primary outcome
Clinical Response to Photodynamic Therapy
Time frame: immediately after termination of treatment course (with an average of 5 month after initiation of PDT)
categorized in 3 groups: complete response: there was no visible or palpable lesion; partial response: there was a visible or palpable lesion but the diameter of the lesion had reduced; no response: there was a visible or palpable lesion and the diameter of the lesion had not reduced
1 secondary outcome
Histologic Resolution of Lesion
Time frame: immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Zohreh Tehranchi-nia, assist.prof. principal investigator
Skin Research Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing photodynamic therapy in people with Basal Cell Carcinoma, run by Shahid Beheshti University of Medical Sciences.
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 8 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 Dec 2009. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Response to Photodynamic Therapy (time frame: immediately after termination of treatment course (with an average of 5 month after initiation of PDT)). 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 Dec 2009.