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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06349447
Enrollment
10
Registered
2024-04-05
Start date
2024-04-10
Completion date
2024-06-01
Last updated
2024-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperpigmentation

Keywords

photobiomodulation, PIE, PIH, LED

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.

Interventions

DEVICELED

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.

OTHERwithout any LED exposition

without any LED exposition

Sponsors

Yanjun Dan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frameDescription
melanin indexat day 8The effect of LED treatment on PIH will be estimated by measure by C-CUBE.
erythema indexat day 8The effect of LED treatment on PIE will be estimated by measure by C-CUBE.

Secondary

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

Countries

China

Contacts

Primary ContactYanjun Dan
danyanjun@126.com+86 159 0194 0897

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026