Clinical and Objective Outcomes of the A.S.A.P. Algorithm for Keloids: A Prospective Longitudinal Within-Patient Study With an Untreated Comparison Group
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Change from Baseline in Vancouver Scar Scale (VSS) Score
研究概览
简要总结
The goal of this clinical trial is to evaluate if the A.S.A.P. algorithm can treat and improve clinical and objective outcomes in patients with keloids.
The main questions it aims to answer are:
Does sequential treatment with the A.S.A.P. algorithm significantly improve keloid scar characteristics and firmness compared to baseline? Are the longitudinal clinical and objective improvements greater in keloids treated with the A.S.A.P. algorithm compared to an untreated control group? Researchers will compare keloids treated with the sequential A.S.A.P. algorithm to a concurrent untreated group of keloids to see if the treatment algorithm produces superior improvements in scar severity and firmness.
Participants will:
Undergo sequential treatment according to the A.S.A.P. algorithm for at least 6 months, which includes hydrocolloid occlusion, Low-Level Laser Therapy (LLLT), vascular-targeted technologies, intralesional triamcinolone plus 5-fluorouracil, and treatment of residual pigmentation.
Complete clinical scar evaluations at baseline and follow-up using the Vancouver Scar Scale (VSS) and Hamilton Scar Scale.
Undergo objective scar firmness measurements at baseline and follow-up using a durometer.
If in the nonrandomized control group, be prospectively observed and assessed at baseline and follow-up without receiving active treatment.
详细描述
Keloid management remains challenging due to clinical heterogeneity, variable treatment responses, and limited objective evidence supporting multimodal treatment strategies. The A.S.A.P. algorithm is a structured, sequential, predominantly nonsurgical protocol incorporating Assessment, Softening, Approach, and Pigmentation management.
This prospective, longitudinal, quasi-experimental study aims to evaluate within-patient changes in clinical and objective keloid outcomes following treatment with the A.S.A.P. algorithm over a minimum 6-month period, while comparing these changes against a concurrent nonrandomized group of untreated keloids.
Study Workflow:
Assessment (A): Initial clinical evaluation, symptom assessment, and classification of keloid lesions.
Softening (S): Application of hydrocolloid occlusion, silicone dressings, or pressure garments for 2-12 months to reduce tissue firmness, alleviate symptoms, and prepare the lesion for injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Male or female patients aged 18 years or older
- •Clinical diagnosis of keloid established by an experienced senior dermatologist
- •No treatment received for keloid for at least 12 months prior to study enrollment
- •Willingness to participate in the study, documented by written informed consent
排除标准
- •Concomitant medical conditions requiring systemic corticosteroids or immunosuppressive therapy
- •Failure to adhere to the proposed treatment protocol
研究组 & 干预措施
A.S.A.P. Treatment Group
Patients receiving sequential treatment according to the A.S.A.P. algorithm.
干预措施: A.S.A.P. Algorithm (Other)
Untreated Control Group
Concurrent nonrandomized control group prospectively observed and assessed at baseline and follow-up without active treatment.
结局指标
主要结局
Change from Baseline in Vancouver Scar Scale (VSS) Score
时间窗: Baseline and at least 6 months post-treatment initiation
The VSS evaluates four clinical scar parameters: vascularity (0-3), pigmentation (0-2), pliability (0-5), and height (0-3), yielding a total score ranging from 0 to 13. Lower scores represent clinical improvement, while higher scores indicate greater scar severity.
次要结局
- Change from Baseline in Hamilton Scar Scale Score(Baseline and at least 6 months post-treatment initiation)
- QualiFibro: Quality of Life Questionnaire for Patients with Fibroproliferative Scars(Baseline and 6-18 months post-treatment initiation)
- Beck Depression Inventory-II(Baseline and at least 6 months post-treatment initiation.)
- Change from Baseline in Objective Scar Firmness(Baseline and at least 6 months post-treatment initiation)
- Measurement of Outcomes on Quality of life(Baseline and 6-18 months post treatment innitiation)
研究者
Gisele Viana de Oliveira
Associate Professor
Faculdade de Ciências Médicas de Minas Gerais