Skin StiffnessNCT07680309
Evaluation Skin Stiffness Gradient on Skin After LLLT
A study testing LLLT intervention on skin biomechanical properties in different duration and wavelength and LLLT intervention on skin biomechanical properties in different duty cycle and applied frequency in people with Skin Stiffness and Skin Thickness, run by Asia University at 1 site in Taiwan.
Trial summary
This study evaluates the effects of Low-Level Laser Therapy (LLLT) on skin elasticity by measuring a 3x3 stiffness gradient across 9 points spaced 1 cm apart. Using an air-pressure pump integrated with an Optical Coherence Tomography (OCT) system, a deep learning model is utilized to automatically segment and track… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Stiffness, Skin Thickness, DFU
- What is being tested?
- LLLT intervention on skin biomechanical properties in different duration and wavelength and LLLT intervention on skin biomechanical properties in different duty cycle and applied frequency
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jan 2025to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy adult
Who cannot join
- People with wound and ulcers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Low-Level Laser Therapy Via Biomechanical Properties Analysis Using Optical Coherence Tomography on Skin
This study evaluates the effects of Low-Level Laser Therapy (LLLT) on skin elasticity by measuring a 3x3 stiffness gradient across 9 points spaced 1 cm apart. Using an air-pressure pump integrated with an Optical Coherence Tomography (OCT) system, a deep learning model is utilized to automatically segment and track micro-scale skin movement during deformation.
- Conditions
- Skin Stiffness, Skin Thickness, DFU, Wound and Injuries
- Being tested
- LLLT intervention on skin biomechanical properties in different duration and wavelength, LLLT intervention on skin biomechanical properties in different duty cycle and applied frequency
- Keywords
- OCT, Skin Thickness, Skin Stiffness, DFU Prevention
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLLT intervention on skin biomechanical properties in different duration and wavelengthOther
LLLT intervention on skin biomechanical properties in three different duration and two LLLT wavelength
LLLT intervention on skin biomechanical properties in different duty cycle and applied frequencyOther
LLLT intervention on skin biomechanical properties in three different duty cycle and two applied frequency
| Study group | Role | What they receive |
|---|---|---|
| Three different LLLT Duration (2 min, 3 min and 5 min) | Active comparator | Measuring biomechanical changes on skin after LLLT for three different duration (2 min, 3 min and 5 min) using stiffness gradient Receives: Other: LLLT intervention on skin biomechanical properties in different duration and wavelength |
| Two different LLLT wavelength (660 and 808 nm) | Active comparator | Measuring biomechanical changes on skin after LLLT for two different LLLT wavelength (660 and 808 nm) using stiffness gradient Receives: Other: LLLT intervention on skin biomechanical properties in different duration and wavelength |
| Three different duty cycle (100%, 30% and 50%) | Active comparator | Measuring biomechanical changes on skin after LLLT for three duty cycle (100%, 30% and 50%) using stiffness gradient Receives: Other: LLLT intervention on skin biomechanical properties in different duty cycle and applied frequency |
| Two different applied frequency (1 Hz and 50 Hz) | Active comparator | Measuring biomechanical changes on skin after LLLT for two different applied frequency (1 Hz and 50 Hz) using stiffness gradient Receives: Other: LLLT intervention on skin biomechanical properties in different duty cycle and applied frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements skin stiffness gradient
This study evaluates the effects of Low-Level Laser Therapy (LLLT) on skin elasticity by measuring a 3x3 stiffness gradient across 9 points spaced 1 cm apart. Using an air-pressure pump integrated with an Optical Coherence Tomography (OCT) system, a deep learning model is utilized to automatically segment and track micro-scale skin movement during deformation.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start10 Jan 2025
- Primary completion15 Jun 2025
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin StiffnessStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilang Titah Ramadhan, Asia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680309
- Sponsor's protocol ID
- CRREC-112-130/2
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Low-Level Laser Therapy Via Biomechanical Properties Analysis Using Optical Coherence Tomography on Skin
- ClinicalTrials.gov ID
- NCT07680309
- Acronym / sponsor ID
- CRREC-112-130/2
- Conditions
- Skin Stiffness, Skin Thickness, DFU, Wound and Injuries
- Keywords
- OCT, Skin Thickness, Skin Stiffness, DFU Prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Asia UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effects of Low-Level Laser Therapy (LLLT) on skin elasticity by measuring a 3x3 stiffness gradient across 9 points spaced 1 cm apart. Using an air-pressure pump integrated with an Optical Coherence Tomography (OCT) system, a deep learning model is utilized to automatically segment and track micro-scale skin movement during deformation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Three different LLLT Duration (2 min, 3 min and 5 min) | Active comparator | Other: LLLT intervention on skin biomechanical properties in different duration and wavelengthMeasuring biomechanical changes on skin after LLLT for three different duration (2 min, 3 min and 5 min) using stiffness gradient |
| Two different LLLT wavelength (660 and 808 nm) | Active comparator | Other: LLLT intervention on skin biomechanical properties in different duration and wavelengthMeasuring biomechanical changes on skin after LLLT for two different LLLT wavelength (660 and 808 nm) using stiffness gradient |
| Three different duty cycle (100%, 30% and 50%) | Active comparator | Other: LLLT intervention on skin biomechanical properties in different duty cycle and applied frequencyMeasuring biomechanical changes on skin after LLLT for three duty cycle (100%, 30% and 50%) using stiffness gradient |
| Two different applied frequency (1 Hz and 50 Hz) | Active comparator | Other: LLLT intervention on skin biomechanical properties in different duty cycle and applied frequencyMeasuring biomechanical changes on skin after LLLT for two different applied frequency (1 Hz and 50 Hz) using stiffness gradient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult
Key exclusion criteria (1 listed)
- People with wound and ulcers
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 |
|---|---|---|
| LLLT intervention on skin biomechanical properties in different duration and wavelengthLLLT intervention on skin biomechanical properties in three different duration and two LLLT wavelength | Other | Three different LLLT Duration (2 min, 3 min and 5 min), Two different LLLT wavelength (660 and 808 nm) |
| LLLT intervention on skin biomechanical properties in different duty cycle and applied frequencyLLLT intervention on skin biomechanical properties in three different duty cycle and two applied frequency | Other | Three different duty cycle (100%, 30% and 50%), Two different applied frequency (1 Hz and 50 Hz) |
Primary outcome
Measurements skin stiffness gradient
Time frame: Through study completion, an average of 1 year
This study evaluates the effects of Low-Level Laser Therapy (LLLT) on skin elasticity by measuring a 3x3 stiffness gradient across 9 points spaced 1 cm apart. Using an air-pressure pump integrated with an Optical Coherence Tomography (OCT) system, a deep learning model is utilized to automatically segment and track micro-scale skin movement during deformation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Skin Stiffness
Active, not recruiting
Evaluating Skin Changes Using Optical Coherence Tomography on Plantar Layers
Skin Thickness, Skin Stiffness
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LLLT intervention on skin biomechanical properties in different duration and wavelength and LLLT intervention on skin biomechanical properties in different duty cycle and applied frequency in people with Skin Stiffness and Skin Thickness, run by Asia University at 1 site in Taiwan.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Measurements skin stiffness gradient (time frame: Through study completion, an average of 1 year). 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 2 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.