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Triple therapy of intractable scars with triamcinolone acetonide, hyaluronidase and fractional CO2 laser a randomized controlled trial

Triple therapy of intractable scars with triamcinolone acetonide, hyaluronidase and fractional CO2 laser a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075524
Enrollment
Unknown
Registered
2023-09-07
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intractable scar

Interventions

Control group:1) Firstly, based on the size and shape of the scar, treatment is performed with a fractional carbon dioxide laser (laser related parameter settings: single mode, spot diameter: 120 um,
2) Then use 30G needle to extract triamcinolone acetonide+lidocaine+adrenaline injection (triamcinolone acetonide (40mg/cm3) 1% Lidocaine solution:adrenaline (1:200000)= 1:1:1) and inject it into the
Experimental group:1) Firstly, based on the size and shape of the scar, treatment is performed with a fractional carbon dioxide laser (with the same parameters as the control group)
2) Then use a 30G needle to extract 1ml of triamcinolone acetonide+ lidocaine+ adrenaline injection. Then inject it into 1500 units of hyaluronidase for injection powder (1500 units/ml) and fully mix

Sponsors

Peking university Shenzhen hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1) Age 18 to 55 years old 2) Patient with intractable scars: Patients with pathological scars (hypertrophic scar or keloid) a. Hypertrophic scar: Occurring at any part of the skin which limited to the extent of the injury, with early redness, thickening, hardening and higher surface than the surrounding skin, often accompanied by itching and pain. b. Keloid: It usually occurs in the neck, earlobe, shoulder, chest, upper arm, etc. It is red, hard, and has poor elasticity. It protrudes from the skin surface beyond the original lesion range and expands to the surrounding normal skin, like crab feet, and may be accompanied by itching or pain. And meet any of the following conditions: a. Pathological scars with large area: Patients with large scar that cannot be directly sutured after surgical resection evaluated by professional doctors; b. Multiple pathological scars: patients with more than three pathological scars throughout the body; c. For the past 3 months or more, the patient has received invalid or recurrent pathological scar treatment, including steroid injection, hyaluronidase injection, laser therapy, surgical incision, and nuclear medicine treatment, etc; 3) Complies with Fitzpatrick skin classification III to IV 4) Sign an informed consent form to participate in this study and be able to cooperate with treatment and complete follow-up work.

Exclusion criteria

Exclusion criteria: 1) Patients have received pathological scar treatment in the past three months, including steroid injection, hyaluronidase injection, laser therapy, surgical incision, and nuclear medicine treatment, etc; 2) Patients with adverse reactions after receiving steroid therapy in the past: local atrophy, indentation, pigmentation, infection, etc 3) Patients with adverse reactions after receiving hyaluronidase injection in the past: allergic reactions such as skin redness, swelling, itching, erythema, etc 4) Patients with adverse reactions after previous photothermal therapy: pigmentation, itching, local swelling, local exudation, or infection 5) Patients with previous history of shingles infection, or with low or impaired immune function 6) Patients with previous history of long-term steroid therapy 7) The injection area is unsuitable for injection or has the risk of infection, such as folliculitis, fungal infection and skin ulceration. 8) Combined with allergic diseases (Contact dermatitis, allergic Hives, etc.) or infectious diseases of the blood system (hepatitis B, syphilis, etc.); 9) Patients with serious medical diseases (such as diabetes, hepatitis, coronary heart disease, Arteriosclerosis, glomerulonephritis, blood system diseases, autoimmune diseases, etc.) and previous history of malignant tumors; 10) Those who are receiving anticoagulant therapy or have been taking anticoagulant activating health products for a long time without stopping taking them for less than one month; 11) Those who have a long-term smoking history and have smoked within 3 months; 12) Women who is pregnant or who is within 6 months postpartum; 13) Individuals with mental illness, lack of self-awareness, inability to accurately express and collaborate; 14) Individuals who participated in other clinical trials within 30 days prior to the first visit of this study;

Design outcomes

Primary

MeasureTime frame
Vancouver Assessment Scale ;

Secondary

MeasureTime frame
Patient Scar Assessment Scale;Global Aesthetic Improvement Scale ;Vancouver Assessment Scale ;Height of the scar;

Countries

China

Contacts

Public ContactYongyan Cui

Department of Plastic and Reconstructive Surgery, Peking university Shenzhen hospital

cyy8188@163.com+86 138 2873 6672

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026