Wound Heal
Conditions
Brief summary
The purpose of this study is to evaluate the effect of light therapy on wound healing after laser treatment.
Detailed description
This study sets out to evaluate the effect of a combination of near infrared (830 nm) red (633 nm) and blue (465nm) light-emitting diode (LED) therapy on wound healing after laser application.
Interventions
DEVICECelluma POD
A blue and near infrared handheld LED device
Sponsors
BioPhotas
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a split-person study design where each participant has one arm with the intervention and the other arm that is control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Adults aged 18 years or older with no active cutaneous disease on bilateral ventral biceps, close to the axilla. Subjects shall have given written informed consent for both the LED therapy and for clinical photography.
Exclusion criteria
Patients will be excluded if any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days to Healing | Assessed from Day 0 to Day 55, up to 56 days | The primary endpoint of this study is time and days to complete healing of the treatment sites. Clinical grading shall be by blinded assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level | Assessed from Day 0 to Day 13, up to 14 days | A secondary outcome measure will be post-treatment pain on a 11-point Lickert scale from 0-10. Higher scores mean a worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LED Treatment LED treatment with Celluma POD device after laser test area
Celluma POD: A blue and near infrared handheld LED device | 25 |
| LED Treatment LED treatment with Celluma POD device after laser test area
Celluma POD: A blue and near infrared handheld LED device | 25 |
| Control No treatment after laser test area | 25 |
| Control No treatment after laser test area | 25 |
| Total | 100 |
Baseline characteristics
| Characteristic | Control | Total | LED Treatment |
|---|---|---|---|
| Age, Continuous | 37 Age | 37 Age | 37 Age |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 wound area | 30 wound area | 15 wound area |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 wound area | 0 wound area | 0 wound area |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 wound area | 20 wound area | 10 wound area |
| Race (NIH/OMB) American Indian or Alaska Native | 0 wound area | 0 wound area | 0 wound area |
| Race (NIH/OMB) Asian | 6 wound area | 12 wound area | 6 wound area |
| Race (NIH/OMB) Black or African American | 0 wound area | 0 wound area | 0 wound area |
| Race (NIH/OMB) More than one race | 0 wound area | 0 wound area | 0 wound area |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 wound area | 0 wound area | 0 wound area |
| Race (NIH/OMB) Unknown or Not Reported | 5 wound area | 10 wound area | 5 wound area |
| Race (NIH/OMB) White | 14 wound area | 28 wound area | 14 wound area |
| Sex: Female, Male Female | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Days to Healing
The primary endpoint of this study is time and days to complete healing of the treatment sites. Clinical grading shall be by blinded assessment.
Time frame: Assessed from Day 0 to Day 55, up to 56 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LED Treatment | Days to Healing | Erythema resolved by day 55 | 0 participants |
| LED Treatment | Days to Healing | Edema resolved by day 27 | 0 participants |
| LED Treatment | Days to Healing | Erythema resolved by day 34 | 1 participants |
| LED Treatment | Days to Healing | Crusting resolved by day 13 | 22 participants |
| LED Treatment | Days to Healing | Edema resolved by day 4 | 25 participants |
| LED Treatment | Days to Healing | Crusting resolved by day 27 | 3 participants |
| LED Treatment | Days to Healing | Erythema healed by day 27 | 24 participants |
| Control | Days to Healing | Crusting resolved by day 27 | 3 participants |
| Control | Days to Healing | Erythema healed by day 27 | 24 participants |
| Control | Days to Healing | Erythema resolved by day 34 | 0 participants |
| Control | Days to Healing | Erythema resolved by day 55 | 1 participants |
| Control | Days to Healing | Edema resolved by day 4 | 24 participants |
| Control | Days to Healing | Edema resolved by day 27 | 1 participants |
| Control | Days to Healing | Crusting resolved by day 13 | 22 participants |
Secondary
Pain Level
A secondary outcome measure will be post-treatment pain on a 11-point Lickert scale from 0-10. Higher scores mean a worse outcome.
Time frame: Assessed from Day 0 to Day 13, up to 14 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LED Treatment | Pain Level | Pain/discomfort-free on day 4 | 23 Participants |
| LED Treatment | Pain Level | Pain/discomfort-free on day 6 | 2 Participants |
| LED Treatment | Pain Level | Reported itch on days 9 and 13, resolved by day 13 | 3 Participants |
| Control | Pain Level | Pain/discomfort-free on day 4 | 23 Participants |
| Control | Pain Level | Pain/discomfort-free on day 6 | 2 Participants |
| Control | Pain Level | Reported itch on days 9 and 13, resolved by day 13 | 0 Participants |