ENERGI-F701 for Female Hair Loss Treatment
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03351322 |
Recruitment Status :
Completed
First Posted : November 22, 2017
Last Update Posted : November 24, 2020
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Condition or disease | Intervention/treatment | Phase |
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Female Pattern Baldness Hair Loss Alopecia | Drug: ENERGI-F701 Drug: Regaine | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 67 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | 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 |
Actual Study Start Date : | May 23, 2018 |
Actual Primary Completion Date : | November 29, 2019 |
Actual Study Completion Date : | December 26, 2019 |

Arm | Intervention/treatment |
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Experimental: ENERGI-F701
ENERGI-F701, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks
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Drug: ENERGI-F701
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
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Drug: Regaine
Regaine are applied for treatment of hair loss. |
- 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)
- The amount of hair loss at each post-treatment visit [ Time Frame: 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
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351322
Taiwan | |
Taipei Veterans General Hospital | |
Taipei, Taiwan |
Responsible Party: | Energenesis Biomedical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT03351322 |
Other Study ID Numbers: |
ENERGI-F701-01 |
First Posted: | November 22, 2017 Key Record Dates |
Last Update Posted: | November 24, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
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 |
Alopecia Hair Loss Female Pattern Baldness |
Alopecia Alopecia Areata Hypotrichosis Hair Diseases Skin Diseases |
Pathological Conditions, Anatomical Minoxidil Antihypertensive Agents Vasodilator Agents |