Trial Outcomes & Findings for Effect of Combined Red and Near Infrared Light-emitting Diode (LED) Therapy on Tissue Regeneration Post Laser Treatment (NCT NCT04834817)
NCT ID: NCT04834817
Last Updated: 2025-04-13
Results Overview
The primary endpoint of this study is time and days to complete healing of the treatment sites. Clinical grading shall be by blinded assessment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Assessed from Day 0 to Day 55, up to 56 days
Results posted on
2025-04-13
Participant Flow
Unit of analysis: wound area
Participant milestones
| Measure |
LED Treatment
LED treatment with Celluma POD device after laser test area
Celluma POD: A blue and near infrared handheld LED device
|
Control
No treatment after laser test area
|
|---|---|---|
|
Overall Study
STARTED
|
25 25
|
25 25
|
|
Overall Study
COMPLETED
|
25 25
|
25 25
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Combined Red and Near Infrared Light-emitting Diode (LED) Therapy on Tissue Regeneration Post Laser Treatment
Baseline characteristics by cohort
| Measure |
LED Treatment
n=25 wound area
LED treatment with Celluma POD device after laser test area
Celluma POD: A blue and near infrared handheld LED device
|
Control
n=25 wound area
No treatment after laser test area
|
Total
n=50 wound area
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37 Age
n=25 wound area
|
37 Age
n=25 wound area
|
37 Age
n=50 wound area
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 wound area
n=25 wound area
|
15 wound area
n=25 wound area
|
30 wound area
n=50 wound area
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 wound area
n=25 wound area
|
0 wound area
n=25 wound area
|
0 wound area
n=50 wound area
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 wound area
n=25 wound area
|
10 wound area
n=25 wound area
|
20 wound area
n=50 wound area
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 wound area
n=25 wound area
|
0 wound area
n=25 wound area
|
0 wound area
n=50 wound area
|
|
Race (NIH/OMB)
Asian
|
6 wound area
n=25 wound area
|
6 wound area
n=25 wound area
|
12 wound area
n=50 wound area
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 wound area
n=25 wound area
|
0 wound area
n=25 wound area
|
0 wound area
n=50 wound area
|
|
Race (NIH/OMB)
Black or African American
|
0 wound area
n=25 wound area
|
0 wound area
n=25 wound area
|
0 wound area
n=50 wound area
|
|
Race (NIH/OMB)
White
|
14 wound area
n=25 wound area
|
14 wound area
n=25 wound area
|
28 wound area
n=50 wound area
|
|
Race (NIH/OMB)
More than one race
|
0 wound area
n=25 wound area
|
0 wound area
n=25 wound area
|
0 wound area
n=50 wound area
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 wound area
n=25 wound area
|
5 wound area
n=25 wound area
|
10 wound area
n=50 wound area
|
PRIMARY outcome
Timeframe: Assessed from Day 0 to Day 55, up to 56 daysThe primary endpoint of this study is time and days to complete healing of the treatment sites. Clinical grading shall be by blinded assessment.
Outcome measures
| Measure |
LED Treatment
n=25 Participants
LED treatment with Celluma POD device after laser test area
Celluma POD: A blue and near infrared handheld LED device
|
Control
n=25 Participants
No treatment after laser test area
|
|---|---|---|
|
Days to Healing
Erythema resolved by day 34
|
1 participants
|
0 participants
|
|
Days to Healing
Erythema resolved by day 55
|
0 participants
|
1 participants
|
|
Days to Healing
Erythema healed by day 27
|
24 participants
|
24 participants
|
|
Days to Healing
Edema resolved by day 4
|
25 participants
|
24 participants
|
|
Days to Healing
Edema resolved by day 27
|
0 participants
|
1 participants
|
|
Days to Healing
Crusting resolved by day 13
|
22 participants
|
22 participants
|
|
Days to Healing
Crusting resolved by day 27
|
3 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Assessed from Day 0 to Day 13, up to 14 daysA secondary outcome measure will be post-treatment pain on a 11-point Lickert scale from 0-10. Higher scores mean a worse outcome.
Outcome measures
| Measure |
LED Treatment
n=25 Participants
LED treatment with Celluma POD device after laser test area
Celluma POD: A blue and near infrared handheld LED device
|
Control
n=25 Participants
No treatment after laser test area
|
|---|---|---|
|
Pain Level
Pain/discomfort-free on day 4
|
23 Participants
|
23 Participants
|
|
Pain Level
Pain/discomfort-free on day 6
|
2 Participants
|
2 Participants
|
|
Pain Level
Reported itch on days 9 and 13, resolved by day 13
|
3 Participants
|
0 Participants
|
Adverse Events
LED Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Dr. Kristen Kelly, Professor and Chair, Dept. of Dermatology
University of California, Irvine
Phone: 949-824-5515
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place