Trial Outcomes & Findings for Photodynamic Therapy in Treating Patients With Skin Cancer (NCT NCT00002975)
NCT ID: NCT00002975
Last Updated: 2013-10-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
180 participants
Primary outcome timeframe
One Year
Results posted on
2013-10-10
Participant Flow
Study was activated in February, 1997, which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry was done by PI's staff. PI died and left incomplete data, and study was terminated in April, 2009.
Participant milestones
| Measure |
Photodynamic Therapy Using 20% Topical ALA
4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
|
|---|---|
|
Overall Study
STARTED
|
180
|
|
Overall Study
Treated With Study Therapy
|
175
|
|
Overall Study
COMPLETED
|
175
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Photodynamic Therapy in Treating Patients With Skin Cancer
Baseline characteristics by cohort
| Measure |
Photodynamic Therapy Using 20% Topical ALA
n=175 Participants
4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
|
|---|---|
|
Age Continuous
|
58.0 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One YearPopulation: PI died, leaving incomplete data. Data not analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Photodynamic Therapy Using 20% Topical ALA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place