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)

NCT ID: NCT07169461

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-16
• Study Completion Date: 2025-12-30

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

ShamLLLT plus ShamIPL

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.

Group Type: SHAM_COMPARATOR

Mechanical with pharmacological treatment

Intervention Type: 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.

ShamIPL

Intervention Type: 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.

ShamLLLT

Intervention Type: 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

LLLT plus ShamIPL

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.

Group Type: EXPERIMENTAL

The blue MY MASK-E

Intervention Type: 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.

Mechanical with pharmacological treatment

Intervention Type: 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.

ShamIPL

Intervention Type: 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.

IPL plus ShamLLLT

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.

Group Type: EXPERIMENTAL

IPL

Intervention Type: 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.

Mechanical with pharmacological treatment

Intervention Type: 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.

ShamLLLT

Intervention Type: 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

LLLT plus IPL

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.

Group Type: EXPERIMENTAL

The blue MY MASK-E

Intervention Type: 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.

IPL

Intervention Type: 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.

Mechanical with pharmacological treatment

Intervention Type: 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.

Interventions

The blue MY MASK-E

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.

Intervention Type: DEVICE

IPL

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.

Intervention Type: DEVICE

Mechanical with pharmacological treatment

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

ShamLLLT

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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

2. Age >18 years.

3. Patients who can understand and follow the study instructions and can adhere to the scheduled follow-up plan.

Exclusion Criteria

1. Patients who received previous treatment IPL or LLLT

2. Poor compliance with eyelid scrubbing using tea tree oil (TTO)

3. Dead demodex mite on lash.

4. Contraindication of IPL: Skin Fitzpatrick scale V/VI, patients with pigmented lesions on the treatment area (Eyelid, Cheek).

5. Pregnancy or breastfeeding.

6. Active Skin disease: facial skin cancer, graft-versus-host disease, systemic lupus erythaematosus

7. Active eye infection: recurrent herpes simplex

8. Other lid disease ocular trauma, ocular deformity scar, exophthalmos, eyelid insufficiency

9. Patients with pigmented lesion on area of treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vannarut Satitpitakul, MD

Role: PRINCIPAL_INVESTIGATOR

Department of ophthalmology, Faculty of Medicine

Locations

Chulalongkorn University

Pathum Wan, Bangkok, Thailand

Countries

Thailand

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

40567

Identifier Type: -

Identifier Source: org_study_id