Wound HealNCT04834817
Effect of Combined Red and Near Infrared Light-emitting Diode (LED) Therapy on Tissue Regeneration Post Laser Treatment
A study testing Celluma POD in people with Wound Heal, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of light therapy on wound healing after laser treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- What is being tested?
- Celluma POD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients will be excluded if any of the exclusion criteria applies
- Subjects refuse to give informed consent for either the phototherapy or the clinical photography.
- Subjects have previous photosensitivity problems (solar urticaria, etc.).
- Subjects are taking any systemic drug or applying any topical drug with known photosensitizing properties.
- Subjects taking any systemic drug with known immunosuppressant properties.
- Subjects applying any medications to the research site (inner biceps, close to the axilla).
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- Subjects have medical or psychosocial conditions associated with a risk of poor protocol compliance.
- Subjects are smokers or have smoked within the last 30 days prior to the trial.
- Subjects have epilepsy or a history of seizures
- Subjects currently taking cortisone injections or any other kind of steroid injections(s)
- Subjects with known cancer tumor in the treatment area or metastasis
Trial locations and contacts
1 site in 1 country.
United States1 site
UCI Beckman Laser Institute and Medical Clinic
Irvine, California, 92697
About this study
Official title: The Effect of Combined Red and Near Infrared Light-emitting Diode (LED) Therapy on Tissue Regeneration Post Laser Treatment
The purpose of this study is to evaluate the effect of light therapy on wound healing after laser treatment.
Read the 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.
- Conditions
- Wound Heal
- Being tested
- Celluma POD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celluma PODDevice
A blue and near infrared handheld LED device
| Study group | Role | What they receive |
|---|---|---|
| LED treatment | Experimental | LED treatment with Celluma POD device after laser test area Receives: Device: Celluma POD |
| Control | No intervention | No treatment after laser test area |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed from Day 0 to Day 55, up to 56 days
Secondary outcomes (1)
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.
Measured: Assessed from Day 0 to Day 13, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Apr 2021
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- BioPhotas
- Responsible party
- Principal investigator, Kristen Kelly, University of California, Irvine
- Investigators
- Kristen Kelly, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834817
- Sponsor's protocol ID
- 20216401
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2021
- Last updated
- 13 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Red and Near Infrared Light-emitting Diode (LED) Therapy on Tissue Regeneration Post Laser Treatment
- ClinicalTrials.gov ID
- NCT04834817
- Acronym / sponsor ID
- 20216401
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- BioPhotas
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Posted 13 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| LED treatment | Experimental | Device: Celluma PODLED treatment with Celluma POD device after laser test area |
| Control | No intervention | –No treatment after laser test area |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- Patients will be excluded if any of the exclusion criteria applies
- Subjects refuse to give informed consent for either the phototherapy or the clinical photography.
- Subjects have previous photosensitivity problems (solar urticaria, etc.).
- Subjects are taking any systemic drug or applying any topical drug with known photosensitizing properties.
- Subjects taking any systemic drug with known immunosuppressant properties.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celluma PODA blue and near infrared handheld LED device | Device | LED treatment |
Primary outcome
Days to Healing
Time frame: 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.
1 secondary outcome
Pain Level
Time frame: Assessed from Day 0 to Day 13, up to 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Kelly, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celluma POD in people with Wound Heal, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days to Healing (time frame: Assessed from Day 0 to Day 55, up to 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.