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Completed

NCT Number: NCT07169461

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)

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.

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Key information

Conditions

Demodex Blepharitis Eye Diseases Eyelid Diseases Meibomian Gland Dysfunction Meibomian Gland Dysfunction (MGD)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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.

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.

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

Primary outcomes

  1. Mean of Demodex Count in 30 days after treatment

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

    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)

Secondary outcomes

  1. Mean of Demodex Count in 90 days after treatment

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

    Mean of Demodex Count in 90 days after treatment per right eye in 90 days after end of treatment.(16th week)

  2. MGD staging (Severity)

    Time frame: Day 0, 8th week,16th week

    OSDI questionnaire used to evaluate ocular dry eye symptoms. Meibum Quality. Meibum Expressibility. Telangiectasia grading: 0-3

  3. Surface Staining: NEI Grading System.

    Time frame: Day 0 , 8th week ,16th week

  4. Lipid Layer Thickness by LIPIVIEW

    Time frame: Day 0 , 8th week , 16th week

  5. Noninvasive break-up time (NIBUT)

    Time frame: Day 0, 8th week,16th week

  6. Tear meniscus height (TMH)

    Time frame: Day 0 , 8th week ,16th week

  7. % Meibomian Gland Loss (MGL)

    Time frame: Day 0 , 8th week ,16th week

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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): A Factorial Randomized Sham-Controlled Trial

Acronym: Ai-Demodex

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 11, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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