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ENERGI-F701 for Female Hair Loss Treatment

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ClinicalTrials.gov Identifier: NCT03351322
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : June 1, 2018
Sponsor:
Collaborator:
A2 Healthcare Taiwan Corporation
Information provided by (Responsible Party):
Energenesis Biomedical Co., Ltd.

Brief Summary:
The objective of this study is to evaluate the efficacy and safety of ENERGI-F701 Solution in female subjects with hair loss.

Condition or disease Intervention/treatment Phase
Female Pattern Baldness Hair Loss Alopecia Drug: ENERGI-F701 Drug: Regaine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

Arm Intervention/treatment
Experimental: ENERGI-F701
ENERGI-F701, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks
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
Drug: Regaine
Regaine are applied for treatment of hair loss.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. The amount of hair loss at each post-treatment visit [ Time Frame: Week 2, 4, 6, 8, 10 ]
  2. 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

  3. 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.

  4. 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.

  5. 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
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

Information from the National Library of Medicine

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


Contacts
Contact: Yi-Fang Cheng, PhD. 886-2-2627-0835 ext 701 yf@energenesis-biomedical.com

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan
Contact: Chih-Chiang Chen, MD. PhD.    886-2-2871-2121 ext 3373    d-derm@vghtpe.gov.tw   
Principal Investigator: Chih-Chiang Chen, MD. PhD.         
Sponsors and Collaborators
Energenesis Biomedical Co., Ltd.
A2 Healthcare Taiwan Corporation

Responsible Party: Energenesis Biomedical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03351322     History of Changes
Other Study ID Numbers: ENERGI-F701-01
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
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

Keywords provided by Energenesis Biomedical Co., Ltd.:
Alopecia
Hair Loss
Female Pattern Baldness

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Vasodilator Agents