Support Care Cancer. 2019 Jul 23. doi: 10.1007/s00520-019-04982-z. [Epub ahead of print]

Impact of a topical lotion, CG428, on permanent chemotherapy-induced alopecia in breast cancer survivors: a pilot randomized double-blind controlled clinical trial (VOLUME RCT).

Kang D^1,2, Kim IR³, Park YH⁴, Im YH⁴, Zhao D⁵, Guallar E^1,2,5, Ahn JS⁶, Cho J^7,8,9,10.

Author information

1

Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, 06351, South Korea.

2

Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea.

3

Cancer Education Center, Samsung Comprehensive Cancer Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea.

4

Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea.

5

Departments of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 2024 E. Monument St, Baltimore, MD, USA.

6

Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea. jinseok.ahn@samsung.com.

7

Department of Clinical Research Design and Evaluation, SAIHST, Sungkyunkwan University, Seoul, 06351, South Korea. jcho@skku.edu.

8

Center for Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea. jcho@skku.edu.

9

Cancer Education Center, Samsung Comprehensive Cancer Center, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, 06351, South Korea. jcho@skku.edu.

10

Departments of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 2024 E. Monument St, Baltimore, MD, USA. jcho@skku.edu.

Abstract

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.

KEYWORDS:

Botanical; Breast neoplasm; Chemotherapy; Hair density; Hair thickness; Permanent chemotherapy-induced alopecia; Topical lotion