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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Improvement Rate in Vancouver Scar Scale (VSS) Total Score at 24 Weeks After the Final Treatment
研究概览
简要总结
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.
详细描述
Keloids are benign fibroproliferative skin disorders characterized by excessive collagen deposition and abnormal scar growth beyond the boundaries of the original wound. Intralesional injection of compound betamethasone is a commonly used treatment for keloids; however, repeated injections are often associated with pain and poor patient tolerance.
This study is a randomized, open-label, single-center clinical trial designed to evaluate the efficacy and safety of transdermal delivery of compound betamethasone using a medium-frequency therapeutic device compared with conventional intralesional injection in patients with keloids.
A total of 45 participants with clinically diagnosed keloids will be enrolled and randomized in a 1:2 ratio into two groups: an intralesional injection group and a transdermal delivery group. Participants in the control group will receive intralesional injections of compound betamethasone directly into keloid lesions. Participants in the experimental group will receive transdermal delivery of compound betamethasone using a medium-frequency therapeutic device.
All participants will receive three treatment sessions over an 8-week treatment period and will be followed for up to 52 weeks. The primary outcome is the improvement rate of Vancouver Scar Scale (VSS) scores at Week 24 compared with baseline. Secondary outcomes include Patient and Observer Scar Assessment Scale (POSAS) scores, pain and pruritus assessed by Verbal Rating Scale (VRS), patient satisfaction, quality of life measures, recurrence rate, and incidence of adverse events.
This study aims to determine whether transdermal delivery of compound betamethasone using a medium-frequency therapeutic device provides comparable or superior efficacy with improved tolerability compared with conventional intralesional injection for the treatment of keloids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Duration of keloid ≥ 6 months (mature keloid).
- •Age ≥ 18 years.
- •Fitzpatrick skin types II-IV.
- •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.
- •Willing to participate and able to provide written informed consent and comply with follow-up visits.
排除标准
- •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.
- •Known allergy or contraindication to Diprospan.
- •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.
- •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.
- •Inability to adhere to treatment schedule or follow-up for personal or other reasons.
研究组 & 干预措施
Transdermal Delivery Group
Participants in this group will receive transdermal delivery of compound betamethasone using a medium-frequency therapeutic device over an 8-week period for a total of three sessions.
干预措施: Medium-frequency Therapeutic Device (Device)
Intralesional Injection Group
Participants in this group will receive intralesional injections of compound betamethasone directly into keloid lesions at predefined intervals over 8 weeks for a total of three treatment sessions.
干预措施: Compound betamethasone (Drug)
Transdermal Delivery Group
Participants in this group will receive transdermal delivery of compound betamethasone using a medium-frequency therapeutic device over an 8-week period for a total of three sessions.
干预措施: Compound betamethasone (Drug)
结局指标
主要结局
Improvement Rate in Vancouver Scar Scale (VSS) Total Score at 24 Weeks After the Final Treatment
时间窗: Baseline and 24 weeks after the final treatment
The version of the Vancouver Scar Scale (VSS) used in this study assesses four scar characteristics: color, thickness, vascularity, and pliability. Color is scored from 0 to 3, thickness from 0 to 4, vascularity from 0 to 3, and pliability from 0 to 5. The total VSS score ranges from 0 to 15. Higher scores indicate greater scar severity and therefore a worse outcome. The primary outcome is the improvement rate in the VSS total score at 24 weeks after the final treatment compared with baseline.
次要结局
- Improvement Rate of Vancouver Scar Scale (VSS) Score at Multiple Time Points(Baseline, Week 4, Week 8, Week 12, Week 24, and Week 52)
- Patient and Observer Scar Assessment Scale (POSAS) Patient Scale Total Score(At the first, second, and third treatment visits, and at 24 and 52 weeks after the final treatment)
- Patient Satisfaction Score(24 and 52 weeks after the final treatment)
- Pain Intensity Assessed Using the Verbal Rating Scale (VRS)(At each follow-up visit through 52 weeks after the final treatment)
- Dermatology Life Quality Index (DLQI) Total Score(Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment)
- Recurrence Rate(Up to Week 52)
- Incidence of Adverse Events(Baseline to Week 52)
- Patient and Observer Scar Assessment Scale (POSAS) Observer Scale Total Score(At the first, second, and third treatment visits, and at 24 and 52 weeks after the final treatment)
- Pruritus Intensity Assessed Using the Verbal Rating Scale (VRS)(At each follow-up visit through 52 weeks after the final treatment)
- Skindex-29 Symptoms Domain Score(Baseline, Week 4, Week 24, and Week 52)
- Skindex-29 Emotions Domain Score(Baseline, Week 4, Week 24, and Week 52)
- Skindex-29 Functioning Domain Score(Baseline, Week 4, Week 24, and Week 52)
- 36-Item Short Form Health Survey (SF-36) Physical Functioning Domain Score(Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment)
- 36-Item Short Form Health Survey (SF-36) Role Limitations Due to Physical Health Domain Score(Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment)
- 36-Item Short Form Health Survey (SF-36) Bodily Pain Domain Score(Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment)
- 36-Item Short Form Health Survey (SF-36) General Health Domain Score(Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment)
- 36-Item Short Form Health Survey (SF-36) Vitality Domain Score(Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment)
- 36-Item Short Form Health Survey (SF-36) Social Functioning Domain Score(Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment)
- 36-Item Short Form Health Survey (SF-36) Role Limitations Due to Emotional Problems Domain Score(Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment)
- 36-Item Short Form Health Survey (SF-36) Mental Health Domain Score(Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment)
- Symptom Checklist-90 (SCL-90) Total Score(Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment)
- 9-Item Hamilton Depression Rating Scale (HAMD) Total Score(Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment)
- Hamilton Anxiety Rating Scale (HAMA) Total Score(Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment)
- Keloid-Specific Quality of Life Questionnaire Physical Domain Score(Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment)
- Keloid-Specific Quality of Life Questionnaire Psychological Domain Score(Baseline, 4 weeks after the final treatment, 24 weeks after the final treatment, and 52 weeks after the final treatment)
研究者
Gao Xinghua
Professor
First Hospital of China Medical University