ENERGI-F701 for Female Hair Loss Treatment

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03351322

Enrollment

Registered

2017-11-22

Start date

2018-05-23

Completion date

2019-12-26

Last updated

2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia, Female Pattern Baldness, Hair Loss

Keywords

Alopecia, Hair Loss, Female Pattern Baldness

Brief summary

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

Interventions

DRUGENERGI-F701

ENERGI-F701 are applied for treatment of hair loss.

DRUGRegaine

Regaine are applied for treatment of hair loss.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The amount of hair loss	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

Measure	Time frame	Description
The amount of hair loss at each post-treatment visit	Week 2, 4, 6, 8, 10	—
The thickness and density of hair	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	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	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	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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026