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Completed

NCT Number: NCT03351322

ENERGI-F701 for Female Hair Loss Treatment

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

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Taipei Veterans General Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ENERGI-F701

Drug

ENERGI-F701 are applied for treatment of hair loss.

Regaine

Drug

Regaine are applied for treatment of hair loss.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Energenesis Biomedical Co., Ltd.

Industry

Collaborators

  • A2 Healthcare Taiwan Corporation

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2017
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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