Trial Outcomes & Findings for Photodynamic Therapy With Levulan® +/- Topical Retinoid Pre-Treatment In The Treatment Of Actinic Keratoses (NCT NCT01053000)
NCT ID: NCT01053000
Last Updated: 2015-08-11
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
12 weeks
Results posted on
2015-08-11
Participant Flow
Participant milestones
| Measure |
Left Arm Tazorac/Right Arm No Tazorac Pre-treatment
Tazorac 0.1% gel was applied for 1 week to the left arm followed by therapy with aminolevulinic acid (ALA-PDT) to both arms, in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
|
Right Arm Tazorac/Left Arm No Pretreatment
Tazorac 0.1% gel was applied for 1 week to the right arm followed by therapy with aminolevulinic acid (ALA-PDT) to both arms, in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Photodynamic Therapy With Levulan® +/- Topical Retinoid Pre-Treatment In The Treatment Of Actinic Keratoses
Baseline characteristics by cohort
| Measure |
All Study Participants
n=10 Participants
Tazorac o.1% gel foer 1 week to the randomly chosen arm
20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment vs ALA-PDT with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
75.4 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Tazorac Treated Arm
n=10 Participants
Tazorac o.1% gel for 1 week to the randomly chosen arm
20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
|
No Pretreatment With Tzorac
n=10 Participants
No pretreatmnet to the randomly chosen arm
20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
|
|---|---|---|
|
Change in Lesion Counts in 25 cm2 Target Area Relative to Baseline.
|
-72 lesions
Standard Deviation 30.3
|
-37.5 lesions
Standard Deviation 41.7
|
Adverse Events
Tazorac Treated Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Pretreatment Arm
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place