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NCT07835438

Transdermal Versus Intralesional Betamethasone for Keloids

Sponsor: First Hospital of China Medical University

View on ClinicalTrials.gov

Summary

This study aims to evaluate the efficacy and safety of transdermal delivery of compound betamethasone using a medium-frequency device compared with intralesional injection in the treatment of keloids. A total of 45 patients will be enrolled and assigned in a 1:2 ratio to either the intralesional injection group or the transdermal delivery group. Participants will receive three treatment sessions over an 8-week period. Clinical outcomes will be assessed using the Vancouver Scar Scale (VSS), Patient and Observer Scar Assessment Scale (POSAS), and patient-reported outcomes at multiple follow-up time points up to 52 weeks. Safety will be evaluated through monitoring of adverse events, vital signs, and laboratory tests.

Official title: A Randomized Controlled Study on the Efficacy and Safety of Transdermal Delivery of Compound Betamethasone Via a Medium-Frequency Device Versus Intralesional Injection in Patients With Keloids

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-04-25

Completion Date

2026-11-29

Last Updated

2026-09-23

Healthy Volunteers

Conditions

Keloid

Interventions

DRUG

Compound betamethasone

Compound betamethasone will be administered either via intralesional injection or transdermal delivery using a medium-frequency therapeutic device.

DEVICE

Medium-frequency Therapeutic Device

A medium-frequency therapeutic device will be used to facilitate transdermal delivery of compound betamethasone into keloid lesions.

Inclusion Criteria: * 1\. Participants diagnosed with keloids by investigators according to established clinical criteria. 2\. At least one keloid lesion with a maximum diameter greater than 0.5 cm. 3. Duration of keloid ≥ 6 months (mature keloid). 4. Age ≥ 18 years. 5. Fitzpatrick skin types II-IV. 6. Participants who are suitable for both intralesional injection of Diprospan and transdermal drug delivery using a medium-frequency therapeutic device. 7\. Participants seeking improvement in the appearance of keloids. 8. Willing to participate and able to provide written informed consent and comply with follow-up visits. Exclusion Criteria: * 1\. Active infection of keloids (e.g., itching, pain, ulceration, suppuration), unhealed wounds, or other skin conditions that may affect efficacy evaluation. 2\. Use of the following treatments within specified timeframes prior to randomization: * Within 2 weeks: topical anti-scar medications. * Within 4 weeks: laser therapy, immunosuppressive agents (e.g., 5-fluorouracil), or systemic antibiotics (e.g., tetracyclines, macrolides). * Within 8 weeks: intralesional Diprospan or triamcinolone injection. * Within 12 weeks: biologic agents with immunomodulatory effects (e.g., monoclonal antibodies). * Within 6 months: radiotherapy or botulinum toxin injection. 3. Known allergy or contraindication to Diprospan. 4. History of coagulation disorders or current/planned use of anticoagulant, antiplatelet, or thrombolytic therapy (e.g., warfarin, aspirin). 5\. Pregnant or breastfeeding women, or those planning pregnancy or unwilling to use contraception. 6\. Patients with severe systemic diseases or abnormal laboratory findings that make them unsuitable for the study (e.g., serious organ disease or active autoimmune disease). 7\. Refusal to sign informed consent. 8. Inability to communicate or comply with study procedures (e.g., cognitive impairment, psychiatric or neurological disorders). 9\. Any other condition deemed unsuitable by the investigator. 10. Inability to adhere to treatment schedule or follow-up for personal or other reasons.

Locations (1)

First Hospital of China Medical University

Shenyang, Liaoning, China