Pilot Study of LED for PIE and PIH

The Therapeutic and Preventive Effects of Light-emitting Diodes (LEDs) Irradiation for Post-inflammatory Erythema and Hyperpigmentation: a Self-controlled

The aim of this study is to explore the effect of medical LEDs (830 nm and 590 nm) in the prevention and treatment of PIE and PIH.

Study Overview

• Status: Recruiting
• Conditions: Hyperpigmentation
• Intervention / Treatment: Device: LED; Other: without any LED exposition

Detailed Description

Evidence regarding the efficacy of LEDs for post-inflammatory erythema (PIE) and post-inflammatory hyperpigmentation (PIH) is limited.

The aim of this study was to evaluate the efficacy of 830 nm and 590 nm LED phototherapies on PIE and PIH.

Design of the study:

308 nm LED light (1.5 MED) induced an in vivo PIE/PIH model on the thigh of ten healthy subjects. 830 nm (60 J/cm2) and 590 nm LED (20 J/cm2) were irradiated respectively. For therapeutic irradiation, PIE/PIH model was induced on D1, and LEDs were irradiated on D0, 1, 3, 6 and 8. For preventive irradiation, LEDs were irradiated on D0, 1, 3, 6 and 8 and PIE/PIH model was induced on D9. Erythema index (EI), melanin index (MI), transdermal water loss (TEWL) and C-Cube photography were measured during 10-day follow-up visits.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanjun Dan; Phone Number: +86 159 0194 0897; Email: danyanjun@126.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Huashan Hospital
    • Contact: Yanjun Dan; Phone Number: +86 159 0194 0897; Email: danyanjun@126.com
    • Contact: Leihong Xiang; Phone Number: +86 13818252671; Email: flora_xiang@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy Asians;
2. 20-65 years old;
3. Fitzpatrick classification III-IV;
4. Sign the informed consent form.

Exclusion Criteria:

1. Have abnormal skin manifestations, such as pigment diseases, photosensitivity diseases and other allergic diseases;
2. Those with a history of abnormal systemic diseases, such as heart disease, liver disease, kidney disease, tumors, and mental illness;
3. Women who are preparing for pregnancy, pregnant or breastfeeding;
4. Have used photosensitizing drugs within two weeks before inclusion in this study;
5. Topical or systemic drugs may be used during this study;
6. bad habits, such as smoking, drinking, etc.;
7. Volunteers who have recently participated in other clinical trials;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: LED irradiation; For therapeutic irradiation, the PIH model was induced on D1, and 830 nm (60 J/cm2, 50 mW/cm2) and 590 nm LED (20 J/cm2, 20 mW/cm2) were irradiated on D0, D1, D3, D6 and D8, respectively. For preventive irradiation, 830 nm and 590 nm LED were irradiated on D0, D1, D3, D6 and D8, respectively, and the PIE/PIH model was induced on D9.	Device: LED; 308 nm LED light was utilized to induce an vivo PIE/PIH model on the thigh of subjects. The irradiation dose was 1.5 MED. Five circular experimental lesions measuring 1.5 × 1.5 cm were selected on the thighs, categorizing into five groups: control group, 830 nm LED treatment group, 590 nm LED treatment group, 830 nm LED prevention group and 590 nm LED prevention group. 830 nm LED and 590 nm LED were irradiated, respectively. For therapeutic irradiation, the PIH model was induced on D1, and 830 nm (60 J/cm2, 50 mW/cm2) and 590 nm LED (20 J/cm2, 20 mW/cm2) were irradiated on D0, D1, D3, D6 and D8, respectively. For preventive irradiation, 830 nm and 590 nm LED were irradiated on D0, D1, D3, D6 and D8, respectively, and the PIE/PIH model was induced on D9.
Active Comparator: Control; the PIH model was induced on D1 and without any LED exposition.	Other: without any LED exposition; without any LED exposition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
melanin index	The effect of LED treatment on PIH will be estimated by measure by C-CUBE.	at day 8
erythema index	The effect of LED treatment on PIE will be estimated by measure by C-CUBE.	at day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
transepidermal water loss (TEWL)	The effect of LED treatment on skin water loss will be estimated by measure by delfin.	at day 8
elasticity	The effect of LED treatment on skin elasticity will be estimated by measure by delfin.	at day 8

Collaborators and Investigators

• Sponsor: Yanjun Dan
• Investigators: Principal Investigator: Leihong Xiang, professor, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2024
• Primary Completion (Estimated): May 10, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: photobiomodulation, PIE, PIH, LED
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation
• Other Study ID Numbers: KY2021-771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No