Trial Outcomes & Findings for Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis (NCT NCT02409732)
NCT ID: NCT02409732
Last Updated: 2018-10-23
Results Overview
Clearance will be estimated clinically as minimal (0%-25%), mild (26%-50%), moderate (51%-75%), good (76%-99%), or complete (100%). Results will also be evaluated by comparing photographs before and immediately after treatments, and 12 and 24 weeks after the last treatment.
COMPLETED
PHASE4
24 participants
Visit 2 (Baseline) to Visit 5 or 6 (Week 24 or 36)
2018-10-23
Participant Flow
Twenty four patients were screened to participate. Three men and one woman did not meet criteria to participate in the study.
Twenty four patients were screened to participate, but only 20 entered into the study (3 men and 1 woman screen failed). This was an open label proof of concept study and our goal was to enroll a total of 20 patients, which we achieved.
Participant milestones
| Measure |
Photodynamic Therapy With Blue Light
Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Photodynamic Therapy With Blue Light
Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis
Baseline characteristics by cohort
| Measure |
Photodynamic Therapy With Blue Light
n=20 Participants
Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.
|
|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
Income
$10,000-25,000
|
1 participants
n=5 Participants
|
|
Income
$26,000-50,000
|
1 participants
n=5 Participants
|
|
Income
$51,000-75,000
|
4 participants
n=5 Participants
|
|
Income
$76,000-100,000
|
4 participants
n=5 Participants
|
|
Income
>$100,000
|
4 participants
n=5 Participants
|
|
Income
Prefer not to answer
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 2 (Baseline) to Visit 5 or 6 (Week 24 or 36)Population: Twenty patients were enrolled into the study. Please see baseline characteristics to understand the patient demographic.
Clearance will be estimated clinically as minimal (0%-25%), mild (26%-50%), moderate (51%-75%), good (76%-99%), or complete (100%). Results will also be evaluated by comparing photographs before and immediately after treatments, and 12 and 24 weeks after the last treatment.
Outcome measures
| Measure |
Photodynamic Therapy With Blue Light
n=20 Participants
Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.
|
|---|---|
|
Number of Participants With a Change in Clearance From Baseline
0% improvement at V6 (week 36)
|
1 Participants
|
|
Number of Participants With a Change in Clearance From Baseline
50% improvement at V6 (week 36)
|
1 Participants
|
|
Number of Participants With a Change in Clearance From Baseline
75% improvement at V6 (week 36)
|
9 Participants
|
|
Number of Participants With a Change in Clearance From Baseline
100% % improvement at V6 (week 36)
|
4 Participants
|
|
Number of Participants With a Change in Clearance From Baseline
Discontinued/Withdrew/Lost to follow up
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 36Population: Twenty participants completed 50 treatments and the change in local skin reaction (pre-treatment, during treatment and post-treatment) was evaluated at each visit. Number of Patients by Number of Treatments received: One Treatment: 4 Two Treatments :2 Three Treatments:14
Subject reported pain before, during and after blue light illumination was documented using a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst pain imaginable). The maximum change in pain is 10 for each occurrence (pain before compared to during treatment and pain during compared to after treatment). This is multiplied by the number of subjects and then divided by the number of treatments to generate the range. The summation of the change between subject reported pain prior to compared to during blue light treatment was divided by the total number of treatments to obtain the average value. The summation of the change between subject reported pain during compared to after blue light treatment was divided by the total number of treatments to obtain the average value.
Outcome measures
| Measure |
Photodynamic Therapy With Blue Light
n=50 Treatment visits
Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.
|
|---|---|
|
Average Change in Participant Reported Pain
Avg change of pain prior to tx to during tx
|
2.86 units on a scale
Interval -4.0 to 4.0
|
|
Average Change in Participant Reported Pain
Avg change of pain during tx to after tx
|
-0.76 units on a scale
Interval -4.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline to Week 36Population: Twenty participants completed 50 treatments and the change in local skin reaction (pre-treatment, during treatment and post-treatment) was evaluated at each visit.
Assessments of swelling, erythema, and flaking/scaling were conducted after each treatment and two days post-treatment using a five-point ordinal scale (0: none to 4: severe). The average change in swelling, erythema and flaking/scaling after each treatment and two days post treatment were divided by the 50 total treatments to obtain the average value.
Outcome measures
| Measure |
Photodynamic Therapy With Blue Light
n=50 Treatment visits
Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.
|
|---|---|
|
Average Change in Local Skin Reactions to Blue Light Treatment
Flaking/Scaling (Skin Dryness)
|
1.82 units on a scale
Interval 0.0 to 4.0
|
|
Average Change in Local Skin Reactions to Blue Light Treatment
Swelling
|
0.72 units on a scale
Interval -1.0 to 3.0
|
|
Average Change in Local Skin Reactions to Blue Light Treatment
Erythema
|
0.58 units on a scale
Interval -2.0 to 3.0
|
SECONDARY outcome
Timeframe: Baseline to Week 36Population: Twenty participants completed 50 treatments and the change in local skin reaction (pre-treatment, during treatment and post-treatment) was evaluated at each visit.
Assessments of vesiculation/pustulation, erosion/ulceration, and crusting were conducted immediately after each blue light treatment using a five-point ordinal scale (0: none to 4: severe). The presence or absence of hyperpigmentation in the treatment area was also documented after each treatment visit. The total number of participants who developed a local skin reaction is documented.
Outcome measures
| Measure |
Photodynamic Therapy With Blue Light
n=50 Treatment visits
Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.
|
|---|---|
|
The Number of Participants Who Developed a Local Skin Reaction to Blue Light Treatment: Vesiculation/Pustulation, Erosion/Ulceration, Crusting and Hyperpigmentation
Vesiculation/Pustulation
|
2 participants
|
|
The Number of Participants Who Developed a Local Skin Reaction to Blue Light Treatment: Vesiculation/Pustulation, Erosion/Ulceration, Crusting and Hyperpigmentation
Erosion/Ulceration
|
0 participants
|
|
The Number of Participants Who Developed a Local Skin Reaction to Blue Light Treatment: Vesiculation/Pustulation, Erosion/Ulceration, Crusting and Hyperpigmentation
Crusting
|
4 participants
|
|
The Number of Participants Who Developed a Local Skin Reaction to Blue Light Treatment: Vesiculation/Pustulation, Erosion/Ulceration, Crusting and Hyperpigmentation
Hyperpigmentation
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 36Evaluation of any reported local or systemic events outside the treatment area and other than those specified under local skin reactions or PDT reactions.
Outcome measures
| Measure |
Photodynamic Therapy With Blue Light
n=20 Participants
Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments.
|
|---|---|
|
Number of Participants With Adverse Events
Upper respiratory infection (URI)
|
1 Participants
|
|
Number of Participants With Adverse Events
Lesion on mid chest
|
1 Participants
|
|
Number of Participants With Adverse Events
Red spots
|
1 Participants
|
|
Number of Participants With Adverse Events
Bleeding esophageal ulcer
|
1 Participants
|
Adverse Events
Photodynamic Therapy With Blue Light
Serious adverse events
| Measure |
Photodynamic Therapy With Blue Light
n=20 participants at risk
Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments
|
|---|---|
|
Gastrointestinal disorders
Bleeding esophageal ulcer
|
5.0%
1/20 • Number of events 1 • Visits 2 (Baseline), Visits 3 (week 6), and Visit 4 (week 12), Visit 5 (week 24), Visit 6 (week 36)
|
Other adverse events
| Measure |
Photodynamic Therapy With Blue Light
n=20 participants at risk
Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
URI
|
5.0%
1/20 • Number of events 1 • Visits 2 (Baseline), Visits 3 (week 6), and Visit 4 (week 12), Visit 5 (week 24), Visit 6 (week 36)
|
|
Skin and subcutaneous tissue disorders
Swelling of right hand
|
5.0%
1/20 • Number of events 1 • Visits 2 (Baseline), Visits 3 (week 6), and Visit 4 (week 12), Visit 5 (week 24), Visit 6 (week 36)
|
|
Skin and subcutaneous tissue disorders
Red spots
|
5.0%
1/20 • Number of events 1 • Visits 2 (Baseline), Visits 3 (week 6), and Visit 4 (week 12), Visit 5 (week 24), Visit 6 (week 36)
|
Additional Information
Dr. Michael Shane Chapman Section Chief of Dermatology
Dartmouth-Hitchcock Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place