Female Pattern BaldnessPhase 2NCT03351322
ENERGI-F701 for Female Hair Loss Treatment
A Phase 2 study testing ENERGI-F701 and Regaine in people with Female Pattern Baldness and Hair Loss, run by Energenesis Biomedical Co., Ltd. at 1 site in Taiwan.
Trial summary
The objective of this study is to evaluate the efficacy and safety of ENERGI-F701 Solution in female subjects with hair loss. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Female Pattern Baldness, Hair Loss, Alopecia
- What is being tested?
- ENERGI-F701 and Regaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 May 2018to 26 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- ENERGI-F701, Regaine
- Keywords
- Alopecia, Hair Loss, Female Pattern Baldness
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENERGI-F701Drug
ENERGI-F701 are applied for treatment of hair loss.
RegaineDrug
Regaine are applied for treatment of hair loss.
| Study group | Role | What they receive |
|---|---|---|
| ENERGI-F701 | Experimental | ENERGI-F701, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks Receives: Drug: ENERGI-F701 |
| Regaine | Active comparator | Regaine, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks Receives: Drug: Regaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 12
Secondary outcomes (5)
The amount of hair loss at each post-treatment visit
Measured: Week 2, 4, 6, 8, 10
The thickness and density of hair
Change of hair thickness and density measured by phototrichogram at each post-treatment visit
Measured: Week 2, 4, 6, 8, 10, 12
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.
Measured: Week 2, 4, 6, 8, 10, 12
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.
Measured: Week 2, 4, 6, 8, 10, 12
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.
Measured: Week 2, 4, 6, 8, 10, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start23 May 2018
- Primary completion29 Nov 2019
- Study completion26 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Pattern BaldnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Energenesis Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- A2 Healthcare Taiwan Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351322
- Sponsor's protocol ID
- ENERGI-F701-01
- Status last verified
- Nov 2020
- First submitted
- 20 Nov 2017
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03351322
- Acronym / sponsor ID
- ENERGI-F701-01
- Conditions
- Female Pattern Baldness, Hair Loss, Alopecia
- Keywords
- Alopecia, Hair Loss, Female Pattern Baldness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Energenesis Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- A2 Healthcare Taiwan Corporation
- Study start
- 23 May 2018 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 26 Dec 2019 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy and safety of ENERGI-F701 Solution in female subjects with hair loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENERGI-F701 | Experimental | Drug: ENERGI-F701ENERGI-F701, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks |
| Regaine | Active comparator | Drug: RegaineRegaine, topical application (1 mL) on the scalp of affected area, twice daily for 12 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENERGI-F701ENERGI-F701 are applied for treatment of hair loss. | Drug | ENERGI-F701 |
| RegaineRegaine are applied for treatment of hair loss. | Drug | Regaine |
Primary outcome
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)
5 secondary outcomes
The amount of hair loss at each post-treatment visit
Time frame: Week 2, 4, 6, 8, 10
The thickness and density of hair
Time frame: Week 2, 4, 6, 8, 10, 12
Investigator assessment at each post-treatment visit
Time frame: Week 2, 4, 6, 8, 10, 12
The hair wash/shed hair count at each post-treatment visit
Time frame: Week 2, 4, 6, 8, 10, 12
The subject satisfaction
Time frame: Week 2, 4, 6, 8, 10, 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ENERGI-F701 and Regaine in people with Female Pattern Baldness and Hair Loss, run by Energenesis Biomedical Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of hair loss (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.