Clinical trial NCT03351322: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Female Pattern Baldness
Hair Loss
Alopecia
Keywords: Alopecia
Hair Loss
Female Pattern Baldness
Lead sponsor: Energenesis Biomedical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: A2 Healthcare Taiwan Corporation
First posted: 2017-11-22
Enrollment: 67
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: The amount of hair loss
timeFrame: Week 12
Secondary outcomes:
measure: The amount of hair loss at each post-treatment visit
timeFrame: Week 2, 4, 6, 8, 10
measure: The thickness and density of hair
timeFrame: Week 2, 4, 6, 8, 10, 12
measure: Investigator assessment at each post-treatment visit
timeFrame: Week 2, 4, 6, 8, 10, 12
measure: The hair wash/shed hair count at each post-treatment visit
timeFrame: Week 2, 4, 6, 8, 10, 12
measure: The subject satisfaction
timeFrame: Week 2, 4, 6, 8, 10, 12
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: