Randomized Phase IIa Trial of Purified Candida Antigen for Common Warts: Evaluating the Safety and Efficacy Across Multiple Dosing Regimens.

IF 3.5 3区医学 Q1 DERMATOLOGY

Dermatology and Therapy Pub Date : 2025-03-29 DOI:10.1007/s13555-025-01387-1

Stacy R Smith, Robert E Esch, H S Nielsen, Sandra Marchese Johnson

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引用次数: 0

Abstract

Introduction: Non-standardized Candida albicans antigens are commonly used for the treatment of common warts (verruca vulgaris); however, clinical studies thus far have not determined optimal dosing. This study assessed three dosing schemes using Candin®, a standardized purified Candida antigen (PCA), for the treatment of common warts.

Methods: This placebo-controlled, randomized phase IIa clinical trial included participants that had 3 to 20 injectable common warts on prespecified anatomical regions. PCA was administered intralesionally for up to 10 injections every 2 weeks, with adjustments to every 3 weeks for local tolerance issues. Three dosing regimens were evaluated: 0.3 or 0.5 mL into a single wart (cohorts 1 and 2, respectively), or 0.3 mL into up to four warts (cohort 3). Total injection volumes in cohorts 2 and 3 were larger than the typical off-label use of C. albicans. The primary outcome was complete resolution of injected warts, while secondary outcomes included safety, tolerability, and the clearance of untreated common warts.

Results: The incidence of clearance of the primary injected wart in placebo participants was 41.9%, compared to 65.9% (relative risk [RR] 1.57; 95% confidence interval [CI] 1.02, 2.42; P = 0.03) in cohort 1, 79.5% (RR 1.89; 95% CI 1.27, 2.82; P = 0.0007) in cohort 2, and 72.5% (RR 1.74; 95% CI 1.19, 2.50; P = 0.005) in cohort 3, and treatment was well tolerated. Injection of 0.5 mL PCA into a single wart also resulted in a significantly higher rate of clearance of untreated common warts compared to placebo (RR 3.2, 95% CI 1.2, 8.0, P = 0.001).

Conclusion: All three dosing regimens of PCA were safe, well tolerated, and resulted in significantly greater clearance of the primary treated wart(s) compared to placebo, but only 0.5 mL injected into a single wart was significantly better than placebo at clearing untreated warts. Typically, a volume of 0.3 mL C. albicans antigen is injected into a single wart; however, these results suggest that a larger volume of 0.5 mL may have greater benefit for patients. A phase III clinical trial is currently underway to confirm these findings.

Trial registration: ClinicalTrials.gov NCT02393417.

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导言：非标准化白色念珠菌抗原通常用于治疗寻常疣（verruca vulgaris）；然而，迄今为止的临床研究尚未确定最佳剂量。本研究评估了使用标准化纯化念珠菌抗原（PCA）Candin®治疗寻常疣的三种剂量方案：这项安慰剂对照随机 IIa 期临床试验的参与者包括在预先指定的解剖区域患有 3 至 20 个注射型寻常疣的患者。PCA经腔内注射，每2周注射10次，局部耐受性问题可调整为每3周注射1次。评估了三种给药方案：单个疣体注射 0.3 毫升或 0.5 毫升（第一组和第二组），最多四个疣体注射 0.3 毫升（第三组）。第 2 组和第 3 组的总注射量大于白细胞介素的典型标示外使用量。主要结果是注射疣完全消退，次要结果包括安全性、耐受性和未治疗寻常疣的清除率：结果：安慰剂参与者的主要注射疣清除率为 41.9%，而队列 1 中的清除率为 65.9%（相对风险 [RR] 1.57；95% 置信区间 [CI] 1.02，2.42；P = 0.03），队列 2 中的清除率为 65.9%（相对风险 [RR] 1.57；95% 置信区间 [CI] 1.02，2.42；P = 0.03）。治疗耐受性良好。与安慰剂相比，向单个疣体注射 0.5 mL PCA 还能显著提高未经治疗的寻常疣的清除率（RR 3.2，95% CI 1.2，8.0，P = 0.001）：PCA的三种给药方案均安全、耐受性良好，与安慰剂相比，对主要治疗疣体的清除率明显更高，但在清除未治疗疣体方面，仅对单个疣体注射0.5毫升的效果明显优于安慰剂。通常情况下，单个疣体注射 0.3 毫升白僵菌抗原；但这些结果表明，注射 0.5 毫升的更大剂量可能会给患者带来更大的益处。目前正在进行 III 期临床试验，以证实这些发现：试验注册：ClinicalTrials.gov NCT02393417。

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来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.