Status:
COMPLETED
ENERGI-F701 for Female Hair Loss Treatment
Lead Sponsor:
Energenesis Biomedical Co., Ltd.
Collaborating Sponsors:
A2 Healthcare Taiwan Corporation
Conditions:
Female Pattern Baldness
Hair Loss
Eligibility:
FEMALE
20+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the efficacy and safety of ENERGI-F701 Solution in female subjects with hair loss.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2019
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT03351322
Start Date
May 23 2018
End Date
December 26 2019
Last Update
November 24 2020
Active Locations (1)
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1
Taipei Veterans General Hospital
Taipei, Taiwan