Low Level Light Therapy & Skin Pigmentation

NCT ID: NCT07173530

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-11

Study Completion Date

2026-08-31

Brief Summary

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The goal of this clinical trial is to determine if there is a difference in eyelid temperature after low-level light therapy (LLLT) in individuals with different amounts of skin pigmentation and dry eye/meibomian gland disease. Participants will have 3 fifteen minute in office LLLT therapy sessions over a period of approximately 7 to 14 days.

Detailed Description

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The primary objective of the study is to determine if there is a difference in the thermal effect of low-level light therapy (LLLT) in individuals with different skin pigmentation (Fitzpatrick skin type I-IV verses Fitzpatrick skin type V-VI) using a clinically available 633nm LLLT system, the Epi-C-Plus (Espansione group, Bologna, Italy).

Conditions

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Dry Eye Meibomian Gland Dysfunction (Disorder)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fitzpatrick skin tone I-IV

Individuals with skin tones I-IV on the Fitzpatrick scale will receive low-level light therapy

Group Type EXPERIMENTAL

Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus).

Intervention Type DEVICE

A mask with Light Emitting Diodes wavelength 633nm will be placed over closed eyes for 15 minutes.

Fitzpatrick skin tone V-VI

Individuals with skin tones V-Vi on the Fitzpatrick scale will receive low-level light therapy

Group Type EXPERIMENTAL

Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus).

Intervention Type DEVICE

A mask with Light Emitting Diodes wavelength 633nm will be placed over closed eyes for 15 minutes.

Interventions

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Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus).

A mask with Light Emitting Diodes wavelength 633nm will be placed over closed eyes for 15 minutes.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Ability to read and understand the study informed consent in English
* Age 18 years or older at enrollment
* Individuals with MGD based on one or more of the following clinical signs/symptoms, e.g., meibum quality score of 1-3 (Bron et al.), meibography score of 1, 2, or 3 on the Pult Meiboscale, non-invasive 1st tear break up time of 10 seconds or less, or an Ocular Surface Disease Index (OSDI) score greater than 12 points.

Exclusion Criteria

* Active anterior segment pathology (e.g., bacterial conjunctivitis, microbial keratitis)
* History of systemic disease associated with aqueous-deficient dry eye disease (e.g., Sjogren's syndrome)
* History of corneal surgery, refractive surgery, or eyelid surgery within 6 months
* History of corneal ectasia (e.g. keratoconus, Pellucid marginal degeneration)
* History of ocular trauma within 6 months
* History of LipiFlow, iLux, Meiboflow, IPL or LLLT within the last 12 months
* Habitual use of photosensitizing medications within the last 30 days
* Pregnant and/or lactating females, by self-report
* Pigmented lesions, tattoos, or skin cancer in the periocular region
* Unwilling to have eyes photographed or video recorded
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Houston

OTHER

Sponsor Role lead

Responsible Party

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Eric R. Ritchey

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The University of Houston College of Optometry

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Eric Ritchey, OD, PhD

Role: CONTACT

713-743-1933

Rachel Redfern, OD, PhD

Role: CONTACT

713-743-1943

Facility Contacts

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Eric Ritchey, OD, PhD

Role: primary

7137431933

Role: backup

Other Identifiers

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STUDY00005386/MOD00007330

Identifier Type: -

Identifier Source: org_study_id

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