Trial Outcomes & Findings for Photodynamic Therapy Using Topical Aminolevulinic Acid in Treating Patients With Actinic Keratosis (NCT NCT00524485)
NCT ID: NCT00524485
Last Updated: 2017-06-14
Results Overview
TERMINATED
NA
12 participants
2017-06-14
Participant Flow
Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.
Participant milestones
| Measure |
Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy
Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy
Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
Baseline Characteristics
Photodynamic Therapy Using Topical Aminolevulinic Acid in Treating Patients With Actinic Keratosis
Baseline characteristics by cohort
| Measure |
Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy
n=12 Participants
Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment Arm 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart
|
|---|---|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 15.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
PRIMARY outcome
Population: Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Population: Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Population: Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.
Outcome measures
Outcome data not reported
Adverse Events
Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place