Clinical trial · Interventional
A 6-month Post-interventional Follow-up Extension of VOLUME Study (VOLUME-2)
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alopecia | — | UNRESOLVED | — |
| Chemotherapy Effects | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CG428 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CG428
- description
- Patients will self-administer the study product twice per day (morning, evening) for 6 months, for the efficacy assessment
- interventionNames
- Other: CG428
Primary outcomes (1)
- measure
- Hair thickness
- timeFrame
- 6 months after intervention
- description
- Objectively quantified hair thickness will measure using Folliscope 4.0, LeadM
Secondary outcomes (8)
- measure
- Chemotherapy-induced alopecia distress Stress Using Chemotherapy induced
- timeFrame
- All time (baseline, 3month and 6 months after intervention)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available