ENERGI-F701 for Female Hair Loss Treatment

NCT03351322 | Completed Phase 2

• 1 other identifier: ENERGI-F701-01
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Female Pattern Baldness; Hair Loss; Alopecia

Keywords

Alopecia; Hair Loss; Female Pattern Baldness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Investigator assessment at each post-treatment visit

  Week 2, 4, 6, 8, 10, 12

• The hair wash/shed hair count at each post-treatment visit

  Week 2, 4, 6, 8, 10, 12

• The subject satisfaction

  Week 2, 4, 6, 8, 10, 12

Study Arms (2)

ENERGI-F701

EXPERIMENTAL

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

Drug: ENERGI-F701

Regaine

ACTIVE COMPARATOR

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

Drug: Regaine

Interventions

ENERGI-F701 DRUG

ENERGI-F701 are applied for treatment of hair loss.

ENERGI-F701

Regaine DRUG

Regaine are applied for treatment of hair loss.

Regaine

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Energenesis Biomedical Co., Ltd.: lead
• A2 Healthcare Taiwan Corporation: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 22, 2017
• Study Start: May 23, 2018
• Primary Completion: November 29, 2019
• Study Completion: December 26, 2019
• Last Updated: November 24, 2020

Record last verified: 2020-11

Locations

TW (1)