A 6-month Post-interventional Follow-up Extension of VOLUME Study (VOLUME-2)

NCT02986412 | Completed

• 1 other identifier: VOLUME2
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

We would suggest to conduct "VOLUME-2" study, as an extension of the ongoing "VOLUME" study with all subjects already included. After completion of VOLUME study, the study will be directly extend with an "open-label design". All participants, who agreed to pursue, with either "Placebo" or "CG428", will receive CG428 treatment for an additional six-month period. VOLUME-2 study would be ideal and timely by enabling no interruption of product use. The Primary Objective is to observe for a longer period the efficacy of CG428 (12 months : 6months Volume + 6 months Volume-2) in order to better discriminate later or non-responder populations. Secondary Objectives are :

• Evaluate how far CG428 can improve hair-pattern (reach a plateau or constant progression)
• Evaluate motivation and adherence of subjects
• Long term safety

Conditions

Alopecia; Chemotherapy Effects

Outcome Measures

Primary Outcomes (1)

• Hair thickness

  Objectively quantified hair thickness will measure using Folliscope 4.0, LeadM

  6 months after intervention

Secondary Outcomes (8)

• Chemotherapy-induced alopecia distress Stress Using Chemotherapy induced

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

• Global photographs

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

• Overall hair and scalp condition

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

• Nail condition

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

• Quality of life at the time

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

Other Outcomes (1)

• Group in VOLUME

  At baseline

Study Arms (1)

CG428

EXPERIMENTAL

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

Other: CG428

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

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
• Patients who participated in VOLUME
• 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, theobromine)
• 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 Links

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

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: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Assistant Professor Department of Clinical Research Design & Evaluation, SAIHST

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: January 15, 2016
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2017
• Last Updated: September 4, 2018

Record last verified: 2018-08

Locations

KR (1)