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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)

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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.

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Funding

This work was supported by Legacy Healthcare and Basic Science Research Program of the National Research Foundation of Korea (NRF) funded by the Ministry of Education (2017R1D1A1B03031654).

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Authors and Affiliations

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

    Danbee Kang, Eliseo Guallar & Juhee Cho

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

    Danbee Kang, Eliseo Guallar & Juhee Cho

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

    Im-Ryung Kim & Juhee Cho

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

    Yeon Hee Park, Young Hyuck Im & Jin Seok Ahn

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

    Di Zhao, Eliseo Guallar & Juhee Cho

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  1. Danbee Kang
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  2. Im-Ryung Kim
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Corresponding authors

Correspondence to Jin Seok Ahn or Juhee Cho.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Kang, D., Kim, IR., Park, Y.H. et al. 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). Support Care Cancer 28, 1829–1837 (2020). https://doi.org/10.1007/s00520-019-04982-z

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