ENERGI-F701 for Female Hair Loss Treatment

Alopecia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351322
• Other study ID #: ENERGI-F701-01
• Status: Completed
• Phase: Phase 2
• Start date: May 23, 2018
• Est. completion date: December 26, 2019

Study information

• Verified date: November 2020
• Source: Energenesis Biomedical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 26, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Female Pattern Baldness
• Hair Loss

Intervention

Drug:
• ENERGI-F701
ENERGI-F701 are applied for treatment of hair loss.
• Regaine
Regaine are applied for treatment of hair loss.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Energenesis Biomedical Co., Ltd.	A2 Healthcare Taiwan Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of hair loss	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)	Week 12
Secondary	The amount of hair loss at each post-treatment visit		Week 2, 4, 6, 8, 10
Secondary	The thickness and density of hair	Change of hair thickness and density measured by phototrichogram at each post-treatment visit	Week 2, 4, 6, 8, 10, 12
Secondary	Investigator assessment at each post-treatment visit	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.	Week 2, 4, 6, 8, 10, 12
Secondary	The hair wash/shed hair count at each post-treatment visit	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.	Week 2, 4, 6, 8, 10, 12
Secondary	The subject satisfaction	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.	Week 2, 4, 6, 8, 10, 12