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

NCT02986412 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2018-09-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Legacy Healthcare Services

    collaborator OTHER

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Juhee Cho, PhD · Samsung Medical Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-15
Primary Completion
2016-12-15
Completion
2017-12-15

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02986412 on ClinicalTrials.gov