CompletedNot Applicable

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

South Korea19 participantsStarted 2016-01-15

Plain-language 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

Who can participate

Age range19 Years – 70 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Hair thickness

Timeframe: 6 months after intervention

Trial details

NCT IDNCT02986412

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12-15