Back to resultsENERGI-F701 for Female Hair Loss Treatment
Primary Purpose
Female Pattern Baldness, Hair Loss, Alopecia
Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
ENERGI-F701
Regaine
Sponsored by
About this trial
This is an interventional treatment trial for Female Pattern Baldness focused on measuring Alopecia, Hair Loss, Female Pattern Baldness
Eligibility Criteria
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
Sites / Locations
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ENERGI-F701
Regaine
Arm Description
ENERGI-F701, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks
Regaine, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks
Outcomes
Primary Outcome Measures
The amount of hair loss
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)
Secondary Outcome Measures
The amount of hair loss at each post-treatment visit
The thickness and density of hair
Change of hair thickness and density measured by phototrichogram at each post-treatment visit
Investigator assessment at each post-treatment visit
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.
The hair wash/shed hair count at each post-treatment visit
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.
The subject satisfaction
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.
Full Information
NCT ID
NCT03351322
First Posted
November 20, 2017
Last Updated
November 23, 2020
Sponsor
Energenesis Biomedical Co., Ltd.
Collaborators
A2 Healthcare Taiwan Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03351322
Brief Title
ENERGI-F701 for Female Hair Loss Treatment
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 23, 2018 (Actual)
Primary Completion Date
November 29, 2019 (Actual)
Study Completion Date
December 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Energenesis Biomedical Co., Ltd.
Collaborators
A2 Healthcare Taiwan Corporation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the efficacy and safety of ENERGI-F701 Solution in female subjects with hair loss.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Pattern Baldness, Hair Loss, Alopecia
Keywords
Alopecia, Hair Loss, Female Pattern Baldness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ENERGI-F701
Arm Type
Experimental
Arm Description
ENERGI-F701, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks
Arm Title
Regaine
Arm Type
Active Comparator
Arm Description
Regaine, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ENERGI-F701
Intervention Description
ENERGI-F701 are applied for treatment of hair loss.
Intervention Type
Drug
Intervention Name(s)
Regaine
Intervention Description
Regaine are applied for treatment of hair loss.
Primary Outcome Measure Information:
Title
The amount of hair loss
Description
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)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
The amount of hair loss at each post-treatment visit
Time Frame
Week 2, 4, 6, 8, 10
Title
The thickness and density of hair
Description
Change of hair thickness and density measured by phototrichogram at each post-treatment visit
Time Frame
Week 2, 4, 6, 8, 10, 12
Title
Investigator assessment at each post-treatment visit
Description
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.
Time Frame
Week 2, 4, 6, 8, 10, 12
Title
The hair wash/shed hair count at each post-treatment visit
Description
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.
Time Frame
Week 2, 4, 6, 8, 10, 12
Title
The subject satisfaction
Description
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.
Time Frame
Week 2, 4, 6, 8, 10, 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
ENERGI-F701 for Female Hair Loss Treatment
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