Pilot Study of LED for PIE and PIH

NCT06349447 | Recruiting DMC

• 1 other identifier: KY2021-771
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperpigmentation

Keywords

photobiomodulation, PIE, PIH, LED

Outcome Measures

Primary Outcomes (2)

• melanin index

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

  at day 8

• erythema index

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

  at day 8

Secondary Outcomes (2)

• transepidermal water loss (TEWL)

  at day 8

• elasticity

  at day 8

Study Arms (2)

Experimental: LED irradiation

EXPERIMENTAL

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.

Device: LED

Control

ACTIVE COMPARATOR

the PIH model was induced on D1 and without any LED exposition.

Other: without any LED exposition

Interventions

LED DEVICE

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.

Experimental: LED irradiation

without any LED exposition OTHER

without any LED exposition

Control

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Asians;
• years old;
• Fitzpatrick classification III-IV;
• Sign the informed consent form.

You may not qualify if:

• Have abnormal skin manifestations, such as pigment diseases, photosensitivity diseases and other allergic diseases;
• Those with a history of abnormal systemic diseases, such as heart disease, liver disease, kidney disease, tumors, and mental illness;
• Women who are preparing for pregnancy, pregnant or breastfeeding;
• Topical or systemic drugs may be used during this study;
• bad habits, such as smoking, drinking, etc.;
• Volunteers who have recently participated in other clinical trials;

Sponsors & Collaborators

• Yanjun Dan: lead

Study Sites (1)

Huashan Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Hyperpigmentation; Mediastinal Emphysema

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Mediastinal Diseases; Thoracic Diseases; Respiratory Tract Diseases; Emphysema; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leihong Xiang, professor

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanjun Dan

CONTACT

+86 159 0194 0897; danyanjun@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Dermatology, Huashan Hospital

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: April 10, 2024
• Primary Completion: May 10, 2024
• Study Completion: June 1, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)