NCT06998589

Brief Summary

Acne vulgaris is a common chronic dermatological condition, affecting approximately 85% of adolescents worldwide and ranking eighth among all chronic diseases. Its exacerbation is often associated with recurrent lesions, inadequate treatment, and poor skincare habits such as squeezing or scratching, which frequently lead to the development of post-acne erythema (PAE). PAE is a vascular lesion located beneath the surface of the skin, characterized by a red appearance due to the clustering of dilated capillaries. Although PAE typically improves within 2 to 6 months, it may persist longer in some cases and even result in post-inflammatory hyperpigmentation. This is particularly prevalent in individuals with darker skin tones, where the incidence of PAE and hyperpigmentation ranges from approximately 45.5% to 87.2%. Facial acne not only affects physical appearance but also significantly impairs social interactions and can lead to psychological distress, including low self-esteem and depression. Low-energy, large-spot 1064 nm Nd:YAG laser, which belongs to the near-infrared spectrum, has deeper skin penetration and can effectively target deeper dermal tissues. In the treatment of PAE, the laser energy is absorbed by dilated microvasculature in the skin, promoting vasoconstriction and reducing localized redness and swelling. The low energy setting minimizes thermal damage while stimulating collagen production, thereby enhancing skin repair and improving the appearance of erythema. Delicate Pulsed Light (DPL) operates by emitting pulses of light at specific wavelengths that selectively target skin chromophores. In treating PAE, DPL precisely controls the wavelength and pulse intensity to target dilated blood vessels, thereby alleviating redness and inflammation. Additionally, DPL stimulates the skin's natural repair mechanisms and promotes collagen synthesis, accelerating the resolution of erythema and enhancing overall skin texture. Compared with conventional Intense Pulsed Light (IPL), DPL offers more accurate light modulation, fewer side effects, and better adaptability to various skin types and conditions. In this study, we conducted a split-face randomized controlled trial to compare the clinical efficacy and safety of low-energy large-spot 1064 nm Nd:YAG laser and DPL in treating acne and PAE. We aimed to explore whether there are significant differences between these two modalities in terms of clinical outcomes for post-acne erythema.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 17, 2025

Last Update Submit

May 30, 2025

Conditions

Keywords

post-acne erythema

Outcome Measures

Primary Outcomes (1)

  • PAE lesion count

    The post-acne erythema (PAE) lesion count is an important objective indicator for assessing the severity of PAE. It involves recording the number of erythematous lesions on the face to evaluate changes before and after treatment. A higher lesion count indicates more severe erythema and poorer skin recovery. The assessment is typically conducted independently by two trained dermatologists under standardized lighting conditions, with high-resolution imaging systems used when necessary to enhance accuracy and consistency. Care is taken to distinguish PAE from other cutaneous manifestations such as active acne, post-inflammatory hyperpigmentation, and scarring. As a quantitative measure of erythema severity and improvement, the lesion count is widely applied in clinical studies involving light-based and laser therapies.

    0, 4, 8, 12 weeks

Secondary Outcomes (3)

  • CEA score

    0, 4, 8, 12 weeks

  • erythema index

    0, 4, 8, 12 weeks

  • GFSS score

    0, 4, 8, 12 weeks

Study Arms (2)

DPL

EXPERIMENTAL

The DPL treatment was randomly applied to one side of the face, with an energy density of 6-8 J/cm². Sessions were performed at intervals of 2-3 weeks, for a total of six treatments.

Other: DPL

Q-switched 1064 nm Nd:YAG laser

EXPERIMENTAL

The randomly assigned half of the face received large-spot, low-energy 1064 nm laser treatment at an energy density of 0.8-1 J/cm², performed at intervals of 2-3 weeks for a total of six sessions.

Other: DPL

Interventions

DPLOTHER

The DPL treatment was randomly applied to one side of the face, with an energy density of 6-8 J/cm². Sessions were performed at intervals of 2-3 weeks, for a total of six treatments..The randomly assigned half of the face received large-spot, low-energy 1064 nm laser treatment at an energy density of 0.8-1 J/cm², performed at intervals of 2-3 weeks for a total of six sessions.

DPLQ-switched 1064 nm Nd:YAG laser

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 60 years, regardless of gender;
  • Clinically and dermatoscopically diagnosed with acne and post-acne erythema (PAE) with bilaterally symmetrical facial lesions;
  • Patients with normal cognitive function and stable mental status;
  • Patients with good communication abilities;
  • Voluntary participation in the study with signed informed consent.

You may not qualify if:

  • Patients meeting any of the following conditions will be excluded from the study:
  • History of photosensitivity;
  • Presence of severe immunological disorders;
  • Keloid or hypertrophic scarring tendency;
  • Pregnant or breastfeeding individuals;
  • Alcohol abuse;
  • Presence of other facial skin diseases;
  • Mental illness or psychiatric disorders that impair compliance;
  • Currently pregnant or lactating;
  • Presence of severe internal medical conditions;
  • Poor treatment compliance or inability to cooperate due to psychiatric conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710004, China

Location

Related Publications (2)

  • Wu X, Wang X, Wu X, Cen Q, Xi W, Shang Y, Zhang Z, Lin X. Intense Pulsed Light Therapy Improves Acne-Induced Post-inflammatory Erythema and Hyperpigmentation: A Retrospective Study in Chinese Patients. Dermatol Ther (Heidelb). 2022 May;12(5):1147-1156. doi: 10.1007/s13555-022-00719-9. Epub 2022 Apr 12.

  • Urban K, Chu S, Giesey RL, Mehrmal S, Uppal P, Delost ME, Delost GR. Burden of skin disease and associated socioeconomic status in Asia: A cross-sectional analysis from the Global Burden of Disease Study 1990-2017. JAAD Int. 2020 Dec 10;2:40-50. doi: 10.1016/j.jdin.2020.10.006. eCollection 2021 Mar.

Study Officials

  • Weihui zeng

    Second Affiliated Hospital of Xi'an Jiaotong University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 17, 2025

First Posted

May 31, 2025

Study Start

January 17, 2025

Primary Completion

May 20, 2025

Study Completion

May 20, 2025

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations