Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma
November 18, 2009 updated by: Shahid Beheshti University of Medical Sciences
The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors that affect response rate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically proven BCCs
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BCC, ALA-PDT
Patients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT
|
treatment of bcc with 5_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
immediately after termination of treatment course (with an average of 5 month after initiation of PDT)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Histologic Resolution of Lesion
Time Frame: immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)
|
disappearance of the lesion in histologic examination
|
immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cosmetic Result
Time Frame: 1 month after termination of treatment course (with an average of 6 months after initiation of PDT)
|
excellent: no scarring, atrophy, or induration, slight or no redness or change in pigmentation compared to the adjacent skin; good: no scarring, atrophy, or induration, moderate redness or increase in pigmentation compared to the adjacent skin; moderate: slight to moderate scarring, atrophy, or induration; and poor: extensive scarring, atrophy, or induration
|
1 month after termination of treatment course (with an average of 6 months after initiation of PDT)
|
|
Location of Lesion
Time Frame: baseline
|
baseline
|
|
|
BCC Type
Time Frame: baseline
|
superficial BCC (sBCC); pigmented BCC(pBCC);nodular BCC (nBCC)
|
baseline
|
|
Past Medical History of Radiotherapy
Time Frame: baseline
|
past medical history of radiotherapy to the site of tumor before its appearance(for another reason)
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Zohreh Tehranchi-nia, assist.prof., Skin Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
September 26, 2009
First Submitted That Met QC Criteria
September 26, 2009
First Posted (Estimate)
September 28, 2009
Study Record Updates
Last Update Posted (Estimate)
December 22, 2009
Last Update Submitted That Met QC Criteria
November 18, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- pdt bcc1
- NCT00985829 (Other Grant/Funding Number: ShaheedBMU)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.