Pilot Study of LED for PIE and PIH

Yanjun Dan10 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperpigmentation

Interventions

LEDDEVICE

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.

without any LED expositionOTHER

without any LED exposition

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Locations (1)

Huashan Hospital

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

melanin index

The effect of LED treatment on PIH will be estimated by measure by C-CUBE.

Time frame: at day 8

erythema index

The effect of LED treatment on PIE will be estimated by measure by C-CUBE.

Time frame: at day 8

Secondary Outcomes

transepidermal water loss (TEWL)

The effect of LED treatment on skin water loss will be estimated by measure by delfin.

Time frame: at day 8

elasticity

The effect of LED treatment on skin elasticity will be estimated by measure by delfin.

Time frame: at day 8

Central Contacts

Yanjun Dan

CONTACT

+86 159 0194 0897 danyanjun@126.com

Data from ClinicalTrials.gov

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