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Trial record 1 of 3 for:    CG428
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A 6-month Post-interventional Follow-up Extension of VOLUME Study (VOLUME-2) (VOLUME2)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02986412
First Posted: December 8, 2016
Last Update Posted: December 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Legacy Healthcare Services
Information provided by (Responsible Party):
Juhee Cho, Samsung Medical Center
  Purpose

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

Condition Intervention
Alopecia Chemotherapy Effects Other: CG428

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Impact of a Topical Lotion, CG428, on Permanent Chemotherapy Induced Hair and Scalp Disorders in Cancer Survivors: An Open-label 6 Months Extension of VOLUME Study.

Further study details as provided by Juhee Cho, Samsung Medical Center:

Primary Outcome Measures:
  • Hair thickness [ Time Frame: 6 months after intervention ]
    Objectively quantified hair thickness will measure using Folliscope 4.0, LeadM


Secondary Outcome Measures:
  • Chemotherapy-induced alopecia distress Stress Using Chemotherapy induced [ Time Frame: All time (baseline, 3month and 6 months after intervention) ]
    Respondents will be instructed to indicate on a 4-point Likert scale on each

  • Global photographs [ Time Frame: All time (baseline, 3month and 6 months after intervention) ]
    Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject using Canon EOS 70D

  • Overall hair and scalp condition [ Time Frame: All time (baseline, 3month and 6 months after intervention) ]
    Patient self-assessment: We will use self-reported questionnaire using visual analogue scale (VAS) ranging from 0 to 10.

  • Nail condition [ Time Frame: All time (baseline, 3month and 6 months after intervention) ]
    Patient self-assessment: We will use self-reported questionnaire using visual analogue scale (VAS) ranging from 0 to 10.

  • Quality of life [ Time Frame: All time (baseline, 3month and 6 months after intervention) ]
    European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 and breast specific module

  • Satisfaction with products [ Time Frame: All time (baseline, 3month and 6 months after intervention) ]
    We will use self-reported questionnaire for satisfaction with the products as well as suggestions for improvement after completion of study with patients who received the CG428.

  • Willing to Pay [ Time Frame: 6 months after intervention ]
    We will ask how much to willing to pay for CG428

  • Hair condition [ Time Frame: All time (baseline, 3month and 6 months after intervention) ]

    Outcomes will be collected using objective methods and patient reported outcomes:

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

    Global photographs: Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject



Other Outcome Measures:
  • Group in VOLUME [ Time Frame: At baseline ]
    Information about what group they belonged to in previous studies


Enrollment: 19
Study Start Date: July 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CG428
Patients will self-administer the study product twice per day (morning, evening) for 6 months, for the efficacy assessment
Other: CG428
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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, theobromine)
  • Pre-existing alopecia or significant scalp disease, which may alter study treatment administration or absorption.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986412


Locations
Korea, Republic of
Danbee Kang
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Legacy Healthcare Services
Investigators
Principal Investigator: Juhee Cho, PhD Samsung Medical Center
  More Information

Additional Information:
Responsible Party: Juhee Cho, Chair, Assistant Professor Department of Clinical Research Design & Evaluation, SAIHST, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02986412     History of Changes
Other Study ID Numbers: VOLUME2
First Submitted: December 6, 2016
First Posted: December 8, 2016
Last Update Posted: December 20, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical