Pilot Study of LED for PIE and PIH

Hyperpigmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06349447
• Other study ID #: KY2021-771
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: April 2024
• Source: Huashan Hospital
• Contact: Yanjun Dan
• Phone: +86 159 0194 0897
• Email: danyanjun[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 1, 2024
• Est. primary completion date: May 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Hyperpigmentation

Intervention

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

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Yanjun Dan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	melanin index	The effect of LED treatment on PIH will be estimated by measure by C-CUBE.	at day 8
Primary	erythema index	The effect of LED treatment on PIE will be estimated by measure by C-CUBE.	at day 8
Secondary	transepidermal water loss (TEWL)	The effect of LED treatment on skin water loss will be estimated by measure by delfin.	at day 8
Secondary	elasticity	The effect of LED treatment on skin elasticity will be estimated by measure by delfin.	at day 8