ENERGI-F701 for Female Hair Loss Treatment

Energenesis Biomedical

Status and phase: Completed; Phase 2

Conditions: Hair Loss; Alopecia; Female Pattern Baldness

Treatments: Drug: Regaine; Drug: ENERGI-F701

Study type: Interventional

Funder types: Industry

Identifiers

NCT03351322

ENERGI-F701-01

Details and patient eligibility

About

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

Enrollment: 67 patients

Sex: Female

Ages: 20+ years old

Volunteers: No 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

67 participants in 2 patient groups

ENERGI-F701

Experimental group

Description:

ENERGI-F701, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks

Treatment:

Drug: ENERGI-F701

Regaine

Active Comparator group

Description:

Regaine, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks

Treatment:

Drug: Regaine