Effectiveness of Low Level Light Therapy and Intense Pulse Light on Mite Count as Adjuntive Therapies in Demodex Blepharitis Using Artificial Intelligent Program (Ai-Demodex)

NCT07169461 | Enrolling By Invitation

• 1 other identifier: 40567
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To evaluate the efficacy of LLLT, IPL, and IPL + LLLT in re ducing demodex count in patients with Demodex Blepharitis. Secondary Objectives: To evaluate the efficacy of LLLT, IPL, and IPL + LLLT in improving ocular surface parameters in Demodex Blepharitis. Sample Size: 88 participant ( 22 participants per group x 4 groups) Study Design: 2x2 Factorial randomized trial. Methodology: The study is composed of 4 groups including 1) control 2) Blue light LLT alone 3) IPL alon e, 4) Blue light LLLT with IPL , and . Both LLLT and IPL will treat weekly for 4 sessions All participants will be instructed to perform warm compression and lid scrub. The outcomes include demodex count, meibum grading and ocular surface parameter were evaluated at 1 and 3 months post treatment.

Conditions

Demodex Blepharitis; Meibomian Gland Dysfunction (MGD)

Keywords

Demodex blepharitis; MGD; Meibomian gland dysfunction; Low level light therapy; LLLT; Intense Pulse Light Therapy; IPL; Demodex mite count; Ocular surface parameters; Demodex mite eradication; Ai in demodex; Ai in MGD

Outcome Measures

Primary Outcomes (1)

• Mean of Demodex Count in 30 days after treatment

  The number of Demodex mites per eyelash on a total of 4 collarettes lashes epilation (2 from upper eyelid ,2 from lower eyelid and identification by anatomical imaginary line of nasal and temporal limbus) per right eye in 30 days after end of treatment. (8th week)

  30 days after end of treatment. (8th week)

Secondary Outcomes (7)

• Mean of Demodex Count in 90 days after treatment

  90 days after end of treatment. (16th week)

• MGD staging (Severity)

  Day 0, 8th week,16th week

• Surface Staining: NEI Grading System.

  Day 0 , 8th week ,16th week

• Lipid Layer Thickness by LIPIVIEW

  Day 0 , 8th week , 16th week

• Noninvasive break-up time (NIBUT)

  Day 0, 8th week,16th week

Study Arms (4)

ShamLLLT plus ShamIPL

SHAM COMPARATOR

ShamLLLT : the MY MASK-E (Espansione Marketing S.p.A., Bologna, Italy) - No eye shields, applying a power off special mask for 15 minutes , once a week for 4 weeks ShamIPL : the Eye-light device (Espansione Marketing S.p.A., Bologna, Italy) - Protective eye shields, 5 time for each eye with flashes of light off , but flashes sound on. with Mechanical with pharmacological treatment : Warm compression 15 minutes + Lid hygiene + 1% TTO for 90 days 1%TTO : OCuSOFT Oust Demodex Eyelid Cleanser Foam Bottle 50ml (OCuSOFT, Richmond, TX) is the only commercially available medication in Thailand that contains 1% tea tree oil.

Procedure: Mechanical with pharmacological treatment; Device: ShamIPL; Device: ShamLLLT

LLLT plus ShamIPL

EXPERIMENTAL

LLLT : The blue MY MASK-E (Espansione Marketing S.p.A., Bologna, Italy) (Thai FDA No 66-2-2-2-0012685) * No eye shields * Applying a special mask for 15 minutes, once a week for 4 weeks ShamIPL : the Eye-light device (Espansione Marketing S.p.A., Bologna, Italy) - Protective eye shields, 5 time for each eye with flashes of light off.but flashes sound on. with Mechanical with pharmacological treatment : Warm compression 15 minutes + Lid hygiene + 1% TTO 2 times per day for 90 days 1%TTO : OCuSOFT Oust Demodex Eyelid Cleanser Foam Bottle 50ml (OCuSOFT, Richmond, TX) is the only commercially available medication in Thailand that contains 1% tea tree oil.

Device: The blue MY MASK-E; Procedure: Mechanical with pharmacological treatment; Device: ShamIPL

IPL plus ShamLLLT

EXPERIMENTAL

IPL : The Eye-light device (Espansione Marketing S.p.A., Bologna, Italy,waveleggths 1,200-1,500 nm, Delivery system 12cm2) (Thai FDA No 66-2-2-2-0012685) : * Protective eye shields * 5 flashes of light were applied for each eye (3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim) * Therapeutic energy level (10-16 joules/ cm2) based on the degree of skin pigmentation. ShamLLLT : the MY MASK-E (Espansione Marketing S.p.A., Bologna, Italy) - No eye shields, applying a power off special mask for 15 minutes , once a week for 4 weeks with Mechanical with pharmacological treatment : Warm compression 15 minutes + Lid hygiene + 1% TTO 2 times per day for 90 days 1%TTO : OCuSOFT Oust Demodex Eyelid Cleanser Foam Bottle 50ml (OCuSOFT, Richmond, TX) is the only commercially available medication in Thailand that contains 1% tea tree oil.

Device: IPL; Procedure: Mechanical with pharmacological treatment; Device: ShamLLLT

LLLT plus IPL

EXPERIMENTAL

IPL : The Eye-light device (Espansione Marketing S.p.A., Bologna, Italy,waveleggths 1,200-1,500 nm, Delivery system 12cm2) (Thai FDA No 66-2-2-2-0012685) : * Protective eye shields * 5 flashes of light were applied for each eye (3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim) * Therapeutic energy level (10-16 joules/ cm2) based on the degree of skin pigmentation. LLLT : The blue MY MASK-E (Espansione Marketing S.p.A., Bologna, Italy) (Thai FDA No 66-2-2-2-0012685) * No eye shields * Applying a special mask for 15 minutes, once a week for 4 weeks with Mechanical with pharmacological treatment : Warm compression 15 minutes + Lid hygiene + 1% TTO 2 times per days for 90 days 1%TTO : OCuSOFT Oust Demodex Eyelid Cleanser Foam Bottle 50ml (OCuSOFT, Richmond, TX) is the only commercially available medication in Thailand that contains 1% tea tree oil.

Device: The blue MY MASK-E; Device: IPL; Procedure: Mechanical with pharmacological treatment

Interventions

ShamLLLT DEVICE

the MY MASK-E (Espansione Marketing S.p.A., Bologna, Italy) - No eye shields, applying a power off special mask for 15 minutes but light on , once a week for 4 weeks

IPL plus ShamLLLT; ShamLLLT plus ShamIPL

The blue MY MASK-E DEVICE

Device-Specific Protocol Blue MyMask® LLLT (Espansione): Emits monochromatic photobiomodulation therapy at 633 nm, distinct from conventional red or near-infrared LLLT used in other studies. Espansione IPL: Uses a patented Optimal Power Energy (OPE®) system with a polychromatic spectrum of 590-1200 nm, allowing sub-threshold energy pulses for selective thermal effects on abnormal telangiectasia and Demodex-related inflammation.

LLLT plus IPL; LLLT plus ShamIPL

IPL DEVICE

IPL : The Eye-light device (Espansione Marketing S.p.A., Bologna, Italy,waveleggths 1,200-1,500 nm, Delivery system 12cm2) (Thai FDA No 66-2-2-2-0012685) : * Protective eye shields * 5 flashes of light were applied for each eye (3 along the inferior orbital rim, 1 at the lateral canthus, and 1 applied horizontally along the inferior orbital rim) * Therapeutic energy level (10-16 joules/ cm2) based on the degree of skin pigmentation.

IPL plus ShamLLLT; LLLT plus IPL

Mechanical with pharmacological treatment PROCEDURE

Mechanical with pharmacological treatment : Warm compression 15 minutes + Lid hygiene + 1% TTO 2 times per day for 90 days 1%TTO : OCuSOFT Oust Demodex Eyelid Cleanser Foam Bottle 50ml (OCuSOFT, Richmond, TX) is the only commercially available medication in Thailand that contains 1% tea tree oil.

IPL plus ShamLLLT; LLLT plus IPL; LLLT plus ShamIPL; ShamLLLT plus ShamIPL

ShamIPL DEVICE

the Eye-light device (Espansione Marketing S.p.A., Bologna, Italy) - Protective eye shields, 5 time for each eye with flashes of light off , but flashes sound on.

LLLT plus ShamIPL; ShamLLLT plus ShamIPL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who received a definite diagnosis of demodex blepharitis based on cylindrical dandruff at the base of the lashes and the presence of at least one alive demodex mites on eyelid margin by microscopy
• Age \>18 years.
• Patients who can understand and follow the study instructions and can adhere to the scheduled follow-up plan.

You may not qualify if:

• Patients who received previous treatment IPL or LLLT
• Poor compliance with eyelid scrubbing using tea tree oil (TTO)
• Dead demodex mite on lash.
• Contraindication of IPL: Skin Fitzpatrick scale V/VI, patients with pigmented lesions on the treatment area (Eyelid, Cheek).
• Pregnancy or breastfeeding.
• Active Skin disease: facial skin cancer, graft-versus-host disease, systemic lupus erythaematosus
• Active eye infection: recurrent herpes simplex
• Other lid disease ocular trauma, ocular deformity scar, exophthalmos, eyelid insufficiency
• Patients with pigmented lesion on area of treatment.

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Vannarut Satitpitakul, MD

  Department of ophthalmology, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: September 11, 2025
• Study Start: January 16, 2025
• Primary Completion: September 15, 2025
• Study Completion: December 30, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)