ENERGI-F701 for Female Hair Loss Treatment

November 23, 2020 updated by: Energenesis Biomedical Co., Ltd.

A Randomized, Double-Blind, Active-controlled, Parallel, Phase II Study to Evaluate Efficacy and Safety of ENERGI-F701 Solution in Female Subjects With Hair Loss

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

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taipei, Taiwan
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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:

Any subject meeting any of the exclusion criteria will be excluded from study participation.

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ENERGI-F701
ENERGI-F701, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks
ENERGI-F701 are applied for treatment of hair loss.
Active Comparator: Regaine
Regaine, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks
Regaine are applied for treatment of hair loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The amount of hair loss
Time Frame: Week 12
Change of the amount of hair loss at Week 12 from baseline.(hair loss is defined as the collection of hairs after combing at the study site)
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The amount of hair loss at each post-treatment visit
Time Frame: Week 2, 4, 6, 8, 10
Week 2, 4, 6, 8, 10
The thickness and density of hair
Time Frame: Week 2, 4, 6, 8, 10, 12
Change of hair thickness and density measured by phototrichogram at each post-treatment visit
Week 2, 4, 6, 8, 10, 12
Investigator assessment at each post-treatment visit
Time Frame: Week 2, 4, 6, 8, 10, 12
The hair loss will be assessed by the investigator using Investigator Photographic Assessment Questionnaire (IPAQ).The change from Baseline in hair growth will be assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased.
Week 2, 4, 6, 8, 10, 12
The hair wash/shed hair count at each post-treatment visit
Time Frame: Week 2, 4, 6, 8, 10, 12
Subjects will collect hairs full day, including after combing and hair-washing. Subjects should turn in these hair collections at each visit. The results will be averaged weekly.
Week 2, 4, 6, 8, 10, 12
The subject satisfaction
Time Frame: Week 2, 4, 6, 8, 10, 12
Subject satisfaction evaluated by Women's Androgenic Alopecia Quality of Life Questionnaire (WAA-QOL) at each post-treatment visit from baseline. WAA-QOL is a sixteen-question questionnaire to evaluate subjects' quality of life influenced by hair loss. Each question will be assessed using the following 7-point scale: 0 = not at all, 1 = a little bit, 2 = somewhat, 3 = a good bit, 4 = quite a bit , 5 = very much, 6 = extremely.
Week 2, 4, 6, 8, 10, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2018

Primary Completion (Actual)

November 29, 2019

Study Completion (Actual)

December 26, 2019

Study Registration Dates

First Submitted

November 20, 2017

First Submitted That Met QC Criteria

November 20, 2017

First Posted (Actual)

November 22, 2017

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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