Pilot Study of LED for PIE and PIH

Not Applicable

Recruiting

• Conditions: Hyperpigmentation
• Interventions: Other: without any LED exposition; Device: LED

• Registration Number: NCT06349447
• Lead Sponsor: Yanjun Dan

Brief Summary

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.

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 Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Study First Posted: 2024-04-05
• Last Update Posted: 2024-04-05
• Study Start: 2024-04-10
• Primary Completion: 2024-05-10
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	without any LED exposition	the PIH model was induced on D1 and without any LED exposition.
Experimental: LED irradiation	LED	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, China