NCT06349447

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Yanjun Dan · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hyperpigmentation

Interventions

Type	Name	Description
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.
OTHER	without any LED exposition	without any LED exposition

Timeline

• Start date: 2024-04-10
• Primary completion: 2024-05-10
• Completion: 2024-06-01
• First posted: 2024-04-05
• Last updated: 2024-04-05

Locations

1 site across 1 country: China