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

NCT02605629 | Completed

• 1 other identifier: VOLUME
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Patients whose hair parameters are below the baseline as measured before the start of the chemotherapy or
2. 2.who complain from incomplete hair regrowth will be eligible to participate in the randomized controlled trial.

Conditions

Alopecia

Outcome Measures

Primary Outcomes (1)

• Recovery rate of hair thickness 6 months after intervention Using Folliscope 4.0, LeadM

  Objectively quantified hair thickness will measure using Folliscope 4.0, LeadM We will take a picture of 15X and 60X on the parietal (To around 2 cm) and then analysis using Folliscope program.

  6 months after randomization

Secondary Outcomes (11)

• Chemotherapy-induced alopecia distress Stress Using Chemotherapy induced alopecia distress scale (CADS)

  6 months after randomization

• Global photographs

  All time (baseline, 3month and 6 months after intervention)

• Scalp skin water levels

  All time (baseline, 3month and 6 months after intervention)

• Sebum on scalp

  All time (baseline, 3month and 6 months after intervention)

• Overall hair and scalp condition

  All time (baseline, 3month and 6 months after intervention)

Other Outcomes (1)

• Effort for managing hair

  All time (baseline, 3month and 6 months after intervention)

Study Arms (2)

CG428

EXPERIMENTAL

Patients will self-administer the study product twice per day (morning, evening) for 6 months, for the efficacy assessment

Other: CG428

Placebo

PLACEBO COMPARATOR

Patients will self-administer the study placebo twice per day (morning, evening) for 6 months, for the efficacy assessment

Other: Placebo

Interventions

CG428 OTHER

The experimental group will receive CG428. For each application, the patient should shake the bottle before spraying 10-12 times directly to the dry scalp whole area, with the nozzle, and then gently massage the whole scalp with fingertips in order to spread the lotion evenly until it has completely penetrated the scalp. Hairs should not be washed or shampooed within 1 hour following study treatment administration. Each dose should be spaced out by minimum 4 hours.

CG428

Placebo OTHER

The placebo group will received placebo which excluded active ingredients. For each application, the patient should shake the bottle before spraying 10-12 times directly to the dry scalp whole area, with the nozzle, and then gently massage the whole scalp with fingertips in order to spread the lotion evenly until it has completely penetrated the scalp. Hairs should not be washed or shampooed within 1 hour following study treatment administration. Each dose should be spaced out by minimum 4 hours.

Placebo

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead
• Legacy Healthcare Services: collaborator

Study Sites (1)

Danbee Kang

Seoul, 135-710, South Korea

Location

Related Publications (4)

• Kim 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 BACKGROUND

• Choi 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 BACKGROUND

• Kang 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 BACKGROUND

• Kondo 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

  BACKGROUND

MeSH Terms

Conditions

Alopecia

Interventions

CG428

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Juhee Cho, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cancer Education Center

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 16, 2015
• Study Start: July 13, 2016
• Primary Completion: June 9, 2017
• Study Completion: June 9, 2017
• Last Updated: September 4, 2018

Record last verified: 2018-08

Locations

KR (1)