PURPOSE This study aimed to evaluate the impact of a topical lotion (CG428) on hair thickness and density in breast cancer survivors with permanent chemotherapy-induced alopecia (PCIA). METHODS The study was a double-blind, randomized controlled trial which conducted from February 2016 to December 2016 at the Samsung Comprehensive Cancer Center in Seoul, South Korea. Breast cancer patients with PCIA were randomized on average of 3.5 years after chemotherapy. Topical lotion (Batch DT023) is a botanical drug under development containing a novel patented blend of 4 botanical ingredients: citrus, cocoa, guarana, and onion. Participants were asked to self-apply the study product or placebo twice per day for 6 months. Changes in hair density and thickness were assessed using a noninvasive bioengineering device, and patient-reported outcomes were evaluated at 3 and 6 months after randomization. RESULTS A total of 35 patients were randomized to intervention (N = 18) or placebo (N = 17). Patients in the intervention group were older than those in the placebo group (52.1 vs. 41.6 years; P < 0.001). The mean hair density (SD) at baseline was 97.6 (6.4) and 126.8 (30.3) hairs/cm2 in the intervention and placebo group, respectively (P = 0.005). The corresponding values for hair thickness were 49.9 (12.7) and 48.1 (8.4) μm, respectively. After 6 months, hair density had increased by 34.7 and 24.9% compared with baseline in the intervention and control groups, respectively (P = 0.37). Corresponding values for hair thickness were 19.8 and 35.6%, respectively (P = 0.23). Similar findings were observed after age adjustment. DISCUSSION In this pilot randomized clinical trial, we observed safety, tolerability, and a trend toward the efficacy of CG428 vs. placebo, especially regarding hair density and self-reported improvement.

中文翻译：

---

外用乳液CG428对乳腺癌幸存者永久性化学疗法诱发的脱发的影响：一项试点随机双盲对照临床试验（VOLUME RCT）。

目的本研究旨在评估局部洗剂（CG428）对患有永久性化学疗法诱发的脱发（PCIA）的乳腺癌幸存者头发厚度和密度的影响。方法该研究是一项双盲，随机对照试验，于2016年2月至2016年12月在韩国首尔的三星综合癌症中心进行。乳腺癌PCIA患者平均在化疗后3.5年随机分组。外用洗剂（批号DT023）是一种正在开发中的植物药，其中包含4种植物成分（柑橘，可可，瓜拉那和洋葱）的新型专利混合物。要求参与者每天两次自用研究产品或安慰剂，共6个月。使用无创生物工程设备评估了头发密度和厚度的变化，并在随机分组后3个月和6个月评估患者报告的结局。结果总共35例患者被随机分为干预组（N = 18）或安慰剂组（N = 17）。干预组的患者年龄大于安慰剂组（52.1 vs. 41.6岁； P <0.001）。干预组和安慰剂组的基线平均头发密度（SD）分别为97.6（6.4）和126.8（30.3）根/ cm2（P = 0.005）。头发厚度的相应值分别为49.9（12.7）和48.1（8.4）μm。6个月后，干预组和对照组的头发密度分别比基线提高了34.7和24.9％（P = 0.37）。头发厚度的相应值分别为19.8和35.6％（P = 0.23）。调整年龄后，观察到类似的结果。