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Status unknownNCT06349447Updated Apr 5, 2024

Pilot Study of LED for PIE and PIH

An interventional study of LED and without any LED exposition in Hyperpigmentation, sponsored by Yanjun Dan. Status unknown at 1 site in China. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-05.

Sponsored by Yanjun Dan · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hyperpigmentation

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Keywords

  • photobiomodulation, PIE, PIH, LED
03

In context

Hyperpigmentation

106 studies on the registry are indexed under Hyperpigmentation; 20 are open to participants now.

This study's planned enrollment of 10 is below the median of 35 across 93 interventional studies indexed under Hyperpigmentation.

Browse Hyperpigmentation studies →

Lead sponsor

This is the only study on the registry with Yanjun Dan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy Asians;
  2. 20-65 years old;
  3. Fitzpatrick classification III-IV;
  4. Sign the informed consent form.

Exclusion criteria

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;
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Experimental: LED irradiation

    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

  • Active comparator
    Control

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

    Other: without any LED exposition

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

06

What researchers measure

Primary outcomes

  1. melanin index

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

    Time frame: at day 8

  2. erythema index

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

    Time frame: at day 8

Secondary outcomes

  1. 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

  2. elasticity

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

    Time frame: at day 8

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06349447
Lead sponsor
Yanjun Dan
Responsible party
Yanjun Dan (Department of Dermatology, Huashan Hospital, Huashan Hospital) — Sponsor-investigator
First posted
Apr 5, 2024
Start date
Apr 10, 2024 (estimated)
Primary completion
May 10, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Apr 5, 2024

Study contacts

Yanjun Dan
Contact
danyanjun@126.com
+86 159 0194 0897
Leihong Xiang, professor
principal investigator · Huashan Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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