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. 2020 Apr;28(4):1829-1837. doi: 10.1007/s00520-019-04982-z. Epub 2019 Jul 23.


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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Adult
  • Alopecia / chemically induced*
  • Alopecia / drug therapy*
  • Antineoplastic Agents / adverse effects*
  • Breast Neoplasms* / drug therapy
  • Breast Neoplasms* / rehabilitation
  • Cacao / chemistry
  • Cancer Survivors*
  • Citrus / chemistry
  • Double-Blind Method
  • Female
  • Hair / drug effects
  • Hair / growth & development
  • Humans
  • Middle Aged
  • Onions / chemistry
  • Paullinia / chemistry
  • Pilot Projects
  • Plant Extracts / administration & dosage*
  • Plant Extracts / adverse effects
  • Plant Preparations / administration & dosage*
  • Plant Preparations / adverse effects
  • Republic of Korea


  • Antineoplastic Agents
  • CG428
  • Plant Extracts
  • Plant Preparations