MedDataX Logo

ENERGI-F701 for Female Hair Loss Treatment

NCT ID: NCT03351322

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-23

Study Completion Date

2019-12-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to evaluate the efficacy and safety of ENERGI-F701 Solution in female subjects with hair loss.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Female Pattern Baldness Hair Loss Alopecia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Alopecia Hair Loss Female Pattern Baldness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ENERGI-F701

ENERGI-F701, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks

Group Type EXPERIMENTAL

ENERGI-F701

Intervention Type DRUG

ENERGI-F701 are applied for treatment of hair loss.

Regaine

Regaine, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks

Group Type ACTIVE_COMPARATOR

Regaine

Intervention Type DRUG

Regaine are applied for treatment of hair loss.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ENERGI-F701

ENERGI-F701 are applied for treatment of hair loss.

Intervention Type DRUG

Regaine

Regaine are applied for treatment of hair loss.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Female, aged at least 20 years old
2. With hair loss over 100 hairs/day
3. Willing to maintain the same hair style, color, shampoo and hair products used, and approximate hair length starting from signing ICF and throughout the study
4. The subject of childbearing potential must show a negative urine or serum pregnancy test at Screening Visit
5. Have signed the written informed consent form

Exclusion Criteria

1. With alopecia areata or cicatricial alopecia
2. With other scalp or hair disorders
3. With prior hair transplant
4. Use wigs or hair weaves
5. Plan to use any other concomitant therapy to treat hair loss, regrowth or volume during the study
6. Have taken any topical or systemic prescription of OTC medications for treating hair loss, hair regrowth and/or hair volume
7. Have used medications known to cause hair thinning, such as Coumadin and anti-depressants/anti-psychotics
8. Have received chemotherapy/cytotoxic agents as well as radiation/laser/surgical therapy of the scalp
9. Have initiated or terminated the use of hormones for birth control or hormone replacement therapy within 6 months. Subject will also be excluded from the study if she plans to initiate or terminate the use of hormones for birth control or hormone replacement therapy during the study.
10. With known or suspected hypersensitivity any ingredients of study product and active control
11. Any hematologic abnormalities.
12. Any serum chemistry abnormalities.
13. Pregnant, lactating, or premenopausal with childbearing potential but not adopting at least one form of birth control.
14. Enrollment in any investigational drug trial
15. With any condition judged by the investigator that entering the trial may be detrimental to the subject
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

A2 Healthcare Taiwan Corporation

INDUSTRY

Sponsor Role collaborator

Energenesis Biomedical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ENERGI-F701-01

Identifier Type: -

Identifier Source: org_study_id