EValuation of the Impact of a TOpical Lotion on Permanent Chemotherapy Induced Hair Disorders in Cancer Survivors

This study aims to evaluate the Impact of a topical Lotion, CG428, on permanent chemotherapy induced hair and scalp disorders in Cancer survivors. This is a double-blind, single center, randomized, controlled trial in breast cancer survivors. Hair condition and parameters of 61 breast cancer survivors who were previously included in DERMA study (a prospective cohort study to assess appearance changes due to breast cancer treatment completed in July, 13th,2013) will be assessed. 1. Patients whose hair parameters are below the baseline as measured before the start of the chemotherapy or 2. who complain from incomplete hair regrowth will be eligible to participate in the randomized controlled trial. Patients who agree to participant in the study will be randomly assigned to two parallel arms (Arm 1: CG428/ Arm 2: Placebo). Patients will self-administer the study product or placebo twice per day (morning, evening) for 6 months, for the efficacy assessment. Primary endpoint was recovery of hair thickness 6 months after intervention as assessed using Folliscope 4.0. Secondary endpoints included hair density at 6 months after intervention, distress due to chemotherapy induced alopecia, scalp skin parameters (water and sebum). Patient-reported hair quality improvement, body image and quality of life, and time to first visible improvement based on global photographs of hair and nails.

Sex

Female

Minimum age

19 Years

Maximum age

70 Years

Inclusion Criteria:

* hair parameters obtained before the start of chemotherapy
* hair parameters obtained 6 months after the completion of chemotherapy

  * whose hair parameters are below the baseline, as measured before the start of chemotherapy during DERMA study, or
  * who complain from incomplete hair regrowth at the time of enrollment (on average 24 months after chemotherapy completion)
* Able to keep their hair style

  * Able to use the study treatment in compliance with the protocol.
* Physical (ECOG≤1) and psychological ability to participate

Exclusion Criteria:

* Concomitant use of other anti-hair-loss treatment or hair growth treatment.
* Patients with recent hair transplants or who plan to have transplants.
* Known allergy or hypersensitivity to some components of CG428 (including allium cepa (onion), citrus, caffeine, the obromine)
* Pre-existing alopecia or significant scalp disease, which may alter study treatment administration or absorption.

• BACKGROUNDKim IR, Cho J, Choi EK, Kwon IG, Sung YH, Lee JE, Nam SJ, Yang JH. Perception, attitudes, preparedness and experience of chemotherapy-induced alopecia among breast cancer patients: a qualitative study. Asian Pac J Cancer Prev. 2012;13(4):1383-8. doi: 10.7314/apjcp.2012.13.4.1383. PMID 22799336
• BACKGROUNDChoi EK, Kim IR, Chang O, Kang D, Nam SJ, Lee JE, Lee SK, Im YH, Park YH, Yang JH, Cho J. Impact of chemotherapy-induced alopecia distress on body image, psychosocial well-being, and depression in breast cancer patients. Psychooncology. 2014 Oct;23(10):1103-10. doi: 10.1002/pon.3531. Epub 2014 Mar 24. PMID 24664939
• BACKGROUNDKang D, Kim IR, Im YH, Park YH, Ahn JS, Lee JE, Nam SJ, Park H, Kim E, Lee HK, Lee DY, Cho J. Quantitative changes in skin composition parameters due to chemotherapy in breast cancer patients: a cohort study. Breast Cancer Res Treat. 2015 Aug;152(3):675-82. doi: 10.1007/s10549-015-3502-4. Epub 2015 Jul 22. PMID 26198993
• BACKGROUNDKondo R et al.,Assessment of the Efficacy of CG 428 in the Recovery from Chemotherapy Long Term Side Effects on Hair in Women (an open label evaluation), Legacy Healthcare Japan, 2013