NCT07680309

Brief 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 micro-scale skin movement during deformation.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
0mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Jan 2025Aug 2026

Study Start

First participant enrolled

January 10, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 2, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Expected
Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

5 months

First QC Date

June 25, 2026

Last Update Submit

June 25, 2026

Conditions

Keywords

OCTSkin ThicknessSkin StiffnessDFU Prevention

Outcome Measures

Primary Outcomes (1)

  • 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.

    Through study completion, an average of 1 year

Study Arms (4)

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

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

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

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

Other: LLLT intervention on skin biomechanical properties in different duty cycle and applied frequency

Interventions

LLLT intervention on skin biomechanical properties in three different duration and two LLLT wavelength

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 three different duty cycle and two applied frequency

Three different duty cycle (100%, 30% and 50%)Two different applied frequency (1 Hz and 50 Hz)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult

You may not qualify if:

  • People with wound and ulcers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asia University

Taichung, Wufeng, 41354, Taiwan

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Optimization of Low-Level Laser Therapy via Biomechanical Properties Analysis Using Optical Coherence Tomography on Skin

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 2, 2026

Study Start

January 10, 2025

Primary Completion

June 15, 2025

Study Completion (Estimated)

August 15, 2026

Last Updated

July 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations