An interventional study of rhGM-CSF-containing gel and 1927-nm TFL in Acne Scars - Atrophic and Wound Healing, sponsored by Second Affiliated Hospital of Xi'an Jiaotong University. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Second Affiliated Hospital of Xi'an Jiaotong University · Not applicable, Interventional, and Treatment
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.
Acne vulgaris is a prevalent chronic inflammatory skin disorder affecting approximately 9% of the global population, with 3-7% of patients developing scarring. Among these, atrophic acne scars (AAS) are the most common subtype, exerting profound aesthetic and psychological burdens that substantially impair patients' quality of life.
The 1927-nm fractional thulium fiber laser (TFL) has emerged as a leading treatment for AAS due to its ability to induce controlled microthermal injury in the superficial dermis, stimulating collagen remodeling and dermal regeneration. Its favorable safety profile-characterized by minimal tissue trauma, rapid recovery, and a low risk of post-inflammatory hyperpigmentation (PIH)-supports its clinical utility. Nonetheless, during the treatment of AAS, the ablative energy generated by the laser inevitably leads to disruption of the epidermal barrier and thermal injury, often resulting in erythema, exudation, crusting, or pigmentation changes during recovery.
Cutaneous wound healing is a multifactorial biological process involving coordinated inflammation, proliferation, and tissue remodeling. Cytokines are essential mediators in this cascade, orchestrating angiogenesis, fibroblast activation, and epithelial regeneration to restore barrier integrity. In the context of post-laser skin wound healing, cytokine-based interventions such as epidermal growth factor (EGF) and fibroblast growth factor (FGF) have demonstrated efficacy in enhancing re-epithelialization and reducing adverse sequelae.
Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a multifunctional cytokine secreted by keratinocytes, macrophages, and T lymphocytes that promotes fibroblast proliferation, keratinocyte migration, angiogenesis, and granulation tissue formation. Emerging research suggests its efficacy in wound healing. Distinct from EGF and FGF, GM-CSF also modulates local inflammation, improves microcirculation, and reduces infection risk, thereby optimizing the immune and metabolic milieu for cutaneous repair. Topical GM-CSF formulations have shown promising outcomes in chronic ulcers, radiation dermatitis and burns, accelerating wound closure and minimizing scar formation. However, evidence regarding its efficacy in laser-induced skin injury remains scarce.
This study represents the first investigation of recombinant human GM-CSF (rhGM-CSF) gel as an adjunctive therapy following 1927-nm TFL treatment for atrophic acne scars. We aimed to evaluate its efficacy in promoting postoperative wound healing and restoring skin barrier function, as well as its clinical value in reducing inflammation, enhancing patient comfort, shortening recovery time, and preventing hyperpigmentation. These findings may provide a theoretical basis for developing optimized, cytokine-assisted post-laser repair strategies in aesthetic dermatology.
Second Affiliated Hospital of Xi'an Jiaotong University is the lead sponsor of 68 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
No intervention after 1927-nm TFL therapy
Device: 1927-nm TFL
rhGM-CSF side was applied recombinant human granulocyte-macrophage colony-stimulating factor-containing gel twice daily (100mg/(cm2\*d)) for 7 days from baseline.
All enrolled patients received once 1927-nm fractional thulium fiber laser (WONTECH, Lavieen, South Korea) treatment on both sides of the face at baseline.
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.
Time frame: 0,1,2,3,4,5,6,7 days
erythema index
Use non-invasive skin analyzer to measure the erythema index on the patient's facial skin at each follow-up visit.The larger the value, the more severe the erythema.
Time frame: 0,3,7,14,30,60 days
melanin index
Use non-invasive skin analyzer to measure the melanin index on the patient's facial skin at each follow-up visit.The larger the value, the higher the melanin level.
Time frame: 0,3,7,14,30,60 days
transepidermal water loss
Use non-invasive skin analyzer to measure the transepidermal water loss on the patient's facial skin at each follow-up visit.The larger the value, the more severe the transdermal water loss.
Time frame: 0,3,7,14,30,60 days
hydration
Use non-invasive skin analyzer to measure the hydration on the patient's facial skin at each follow-up visit.The larger the value, the more severe the hydration.
Time frame: 0,3,7,14,30,60 days
ECCA score
Time frame: 0,60 days
GAGS score
Time frame: 0,60 days
GAIS score
Time frame: 60 days
Patient satisfaction evaluation
Patient satisfaction was evaluated as very satisfied, satisfied, relatively satisfied and dissatisfied.
Time frame: 60 days
Plan to share: No
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Second Affiliated Hospital of Xi'an Jiaotong University