- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03351322
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
Conditions
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
-
-
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Taipei, Taiwan
- Taipei Veterans General Hospital
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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:
- Female, aged at least 20 years old
- With hair loss over 100 hairs/day
- 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
- The subject of childbearing potential must show a negative urine or serum pregnancy test at Screening Visit
- Have signed the written informed consent form
Exclusion Criteria:
Any subject meeting any of the exclusion criteria will be excluded from study participation.
- With alopecia areata or cicatricial alopecia
- With other scalp or hair disorders
- With prior hair transplant
- Use wigs or hair weaves
- Plan to use any other concomitant therapy to treat hair loss, regrowth or volume during the study
- Have taken any topical or systemic prescription of OTC medications for treating hair loss, hair regrowth and/or hair volume
- Have used medications known to cause hair thinning, such as Coumadin and anti-depressants/anti-psychotics
- Have received chemotherapy/cytotoxic agents as well as radiation/laser/surgical therapy of the scalp
- 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.
- With known or suspected hypersensitivity any ingredients of study product and active control
- Any hematologic abnormalities.
- Any serum chemistry abnormalities.
- Pregnant, lactating, or premenopausal with childbearing potential but not adopting at least one form of birth control.
- Enrollment in any investigational drug trial
- 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
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ENERGI-F701 are applied for treatment of hair loss.
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Active Comparator: Regaine
Regaine, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks
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Regaine are applied for treatment of hair loss.
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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)
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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
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Week 2, 4, 6, 8, 10
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The thickness and density of hair
Time Frame: Week 2, 4, 6, 8, 10, 12
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Change of hair thickness and density measured by phototrichogram at each post-treatment visit
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Week 2, 4, 6, 8, 10, 12
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Investigator assessment at each post-treatment visit
Time Frame: Week 2, 4, 6, 8, 10, 12
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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.
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Week 2, 4, 6, 8, 10, 12
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The hair wash/shed hair count at each post-treatment visit
Time Frame: Week 2, 4, 6, 8, 10, 12
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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.
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Week 2, 4, 6, 8, 10, 12
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The subject satisfaction
Time Frame: Week 2, 4, 6, 8, 10, 12
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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.
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Week 2, 4, 6, 8, 10, 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENERGI-F701-01
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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