Demodex BlepharitisAi-DemodexNCT07169461
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 study testing The blue MY MASK-E, IPL and Mechanical with pharmacological treatment in people with Demodex Blepharitis and Meibomian Gland Dysfunction (MGD), run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Demodex Blepharitis, Meibomian Gland Dysfunction (MGD)
- What is being tested?
- The blue MY MASK-E, IPL and Mechanical with pharmacological treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2025to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
Primary Objective:
To evaluate the efficacy of LLLT, IPL, and IPL + LLLT in re ducing demodex count in patients with Demodex Blepharitis.
Read more
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.
- Being tested
- The blue MY MASK-E, IPL, Mechanical with pharmacological treatment, ShamIPL, ShamLLLT
- 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
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The blue MY MASK-EDevice
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.
IPLDevice
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 treatmentProcedure or surgery
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.
ShamIPLDevice
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.
ShamLLLTDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: The blue MY MASK-E; Device: IPL; Procedure: Mechanical with pharmacological treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days after end of treatment. (8th week)
Secondary outcomes (7)
Mean of Demodex Count in 90 days after treatment
Mean of Demodex Count in 90 days after treatment per right eye in 90 days after end of treatment.(16th week)
Measured: 90 days after end of treatment. (16th week)
MGD staging (Severity)
OSDI questionnaire used to evaluate ocular dry eye symptoms. Meibum Quality. Meibum Expressibility. Telangiectasia grading: 0-3
Measured: Day 0, 8th week,16th week
Surface Staining: NEI Grading System.
Measured: Day 0 , 8th week ,16th week
Lipid Layer Thickness by LIPIVIEW
Measured: Day 0 , 8th week , 16th week
Noninvasive break-up time (NIBUT)
Measured: Day 0, 8th week,16th week
Tear meniscus height (TMH)
Measured: Day 0 , 8th week ,16th week
% Meibomian Gland Loss (MGL)
Measured: Day 0 , 8th week ,16th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Feb 2025
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Demodex BlepharitisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sirin Triwutpipatkul, MD, Principal investigator, Department of ophthalmology, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169461
- Sponsor's protocol ID
- 40567
- Acronym
- Ai-Demodex
- Status last verified
- Jul 2026
- First submitted
- 11 Mar 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07169461
- Acronym / sponsor ID
- Ai-Demodex / 40567
- Keywords
- Demodex blepharitis, MGD, Meibomian gland dysfunction, Low level light therapy, LLLT, Intense Pulse Light Therapy, IPL, Demodex mite count
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 11 Sep 2025 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ShamLLLT plus ShamIPL | Sham comparator | Procedure: Mechanical with pharmacological treatment, Device: ShamIPL, Device: ShamLLLTShamLLLT : 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. |
| LLLT plus ShamIPL | Experimental | Device: The blue MY MASK-E, Procedure: Mechanical with pharmacological treatment, Device: ShamIPLLLLT : 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. |
| IPL plus ShamLLLT | Experimental | Device: IPL, Procedure: Mechanical with pharmacological treatment, Device: ShamLLLTIPL : 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. |
| LLLT plus IPL | Experimental | Device: The blue MY MASK-E, Device: IPL, Procedure: Mechanical with pharmacological treatmentIPL : 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| The blue MY MASK-EDevice-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. | Device | LLLT plus IPL, LLLT plus ShamIPL |
| IPLIPL : 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. | Device | IPL plus ShamLLLT, LLLT plus IPL |
| Mechanical with pharmacological treatmentMechanical 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. | Procedure or surgery | IPL plus ShamLLLT, LLLT plus IPL, LLLT plus ShamIPL, ShamLLLT plus ShamIPL |
| ShamIPLthe 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. | Device | LLLT plus ShamIPL, ShamLLLT plus ShamIPL |
| ShamLLLTthe 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 | Device | IPL plus ShamLLLT, ShamLLLT plus ShamIPL |
Primary outcome
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)
7 secondary outcomes
Mean of Demodex Count in 90 days after treatment
Time frame: 90 days after end of treatment. (16th week)
MGD staging (Severity)
Time frame: Day 0, 8th week,16th week
Surface Staining: NEI Grading System.
Time frame: Day 0 , 8th week ,16th week
Lipid Layer Thickness by LIPIVIEW
Time frame: Day 0 , 8th week , 16th week
Noninvasive break-up time (NIBUT)
Time frame: Day 0, 8th week,16th week
Tear meniscus height (TMH)
Time frame: Day 0 , 8th week ,16th week
% Meibomian Gland Loss (MGL)
Time frame: Day 0 , 8th week ,16th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Sirin Triwutpipatkul, MD principal investigator
Department of ophthalmology, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The blue MY MASK-E, IPL and Mechanical with pharmacological treatment in people with Demodex Blepharitis and Meibomian Gland Dysfunction (MGD), run by Chulalongkorn University at 1 site in Thailand.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 13 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 Thailand. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean of Demodex Count in 30 days after treatment (time frame: 30 days after end of treatment. (8th week)). 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 13 Jul 2026.