Effectiveness of a rhGM-CSF-containing Gel on Promoting Recovery After 1927-nm Fractional Thulium Fiber Laser Treatment of Atrophic Acne Scars.

NCT07305675 | Completed

• 1 other identifier: 2024220
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Atrophic acne scars (AAS) is one of the most common skin sequelae following acne vulgaris. Fractional laser has shown great therapeutic potential in recent years, while there is no standard of wound care after laser resurfacing. Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a multifunctional cytokine, and has shown its value in many other acute wounds healing. In the present study, we investigated the efficacy and safety of topical recombinant human GM-CSF combined with 1927-nm fractional thulium fiber laser (TFL) in AAS treatment.

Conditions

Acne Scars - Atrophic; Wound Healing

Keywords

Acne Scars; fractional thulium fiber laser; Granulocyte-macrophage colony-stimulating factor; Acute wound healing

Outcome Measures

Primary Outcomes (1)

• IGA score

  The IGA score can be used to estimate the overall severity of the patient's condition. The score ranges from 0 to 4, with higher scores indicating more severe conditions.

  0,1,2,3,4,5,6,7 days

Secondary Outcomes (8)

• erythema index

  0,3,7,14,30,60 days

• melanin index

  0,3,7,14,30,60 days

• transepidermal water loss

  0,3,7,14,30,60 days

• hydration

  0,3,7,14,30,60 days

• ECCA score

  0,60 days

Study Arms (2)

rhGM-CSF side

EXPERIMENTAL

We applied rhGM-CSF-containing gel (Changchun GeneScience Pharmaceutical Corporation Ltd, China) twice daily (100mg/(cm2\*d)) for 7 days after 1927-nm TFL therapy.

Drug: rhGM-CSF-containing gel; Device: 1927-nm TFL

Control Side

OTHER

No intervention after 1927-nm TFL therapy

Device: 1927-nm TFL

Interventions

rhGM-CSF-containing gel DRUG

rhGM-CSF side was applied recombinant human granulocyte-macrophage colony-stimulating factor-containing gel twice daily (100mg/(cm2\*d)) for 7 days from baseline.

rhGM-CSF side

1927-nm TFL DEVICE

All enrolled patients received once 1927-nm fractional thulium fiber laser (WONTECH, Lavieen, South Korea) treatment on both sides of the face at baseline.

Control Side; rhGM-CSF side

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed with atrophic acne scars with essentially symmetric bilateral facial lesion areas, and a Global Scarring Severity (GSS) scale score of Grade 2 or 3 (qualitative assessment);
• Patients with normal cognitive function and mental status;
• Patients with adequate communication ability;
• Patients who voluntarily participate in the split-face controlled study and provide written informed consent.

You may not qualify if:

• Having received systemic medications, dermabrasion, or laser therapy within the past 3 months;
• Females who are pregnant, lactating, or planning to become pregnant;
• Presence of severe systemic diseases;
• Psychiatric disorders or impaired capacity for self-care;
• Photosensitivity or having taken photosensitizing medications within the past month;
• Atopic diathesis or history of severe allergic reactions;
• History of skin exposure to intense sunlight within the past month;
• History of keloid formation;
• Presence of active skin tumors or infections;
• Subjects allergic to rhGM-CSF gel or similar products;
• Other subjects deemed ineligible for the study.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

1927-Nm Fractional Thulium Fiber Laser

Xi'an, Shaanxi, 710004, China

Location

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: December 12, 2025
• First Posted: December 26, 2025
• Study Start: January 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)