Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma
2 other identifiers
interventional
28
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors that affect response rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 26, 2009
CompletedFirst Posted
Study publicly available on registry
September 28, 2009
CompletedResults Posted
Study results publicly available
December 22, 2009
CompletedDecember 22, 2009
November 1, 2009
6 months
September 26, 2009
September 30, 2009
November 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
immediately after termination of treatment course (with an average of 5 month after initiation of PDT)
Secondary Outcomes (1)
Histologic Resolution of Lesion
immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)
Other Outcomes (4)
Cosmetic Result
1 month after termination of treatment course (with an average of 6 months after initiation of PDT)
Location of Lesion
baseline
BCC Type
baseline
- +1 more other outcomes
Study Arms (1)
BCC, ALA-PDT
EXPERIMENTALPatients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT
Interventions
treatment of bcc with 5\_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly
Eligibility Criteria
You may qualify if:
- Histologically proven BCCs
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Zohreh Tehranchi-nia, assist. prof
- Organization
- skin research center
Study Officials
- PRINCIPAL INVESTIGATOR
Zohreh Tehranchi-nia, assist.prof.
Skin Research Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 26, 2009
First Posted
September 28, 2009
Study Start
January 1, 2008
Primary Completion
July 1, 2008
Study Completion
March 1, 2009
Last Updated
December 22, 2009
Results First Posted
December 22, 2009
Record last verified: 2009-11