Clinical Trials List
Protocol NumberENERGI-F701-01
NCT Number(ClinicalTrials.gov Identfier)NCT03351322
2018-03-01 - 2020-02-29
Phase II
Recruiting1
Terminated1
ICD-10L65.9
Nonscarring hair loss, unspecified
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
-
Trial Applicant
A2 HEALTHCARE TAIWAN CORPORATION
-
Sponsor
Energenesis Biomedical
-
Trial scale
Taiwan Single Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Cheng-Yuan Li Division of Dermatology
- 吳貞宜 Division of Dermatology
- DINGDAR LEE Division of Dermatology
- Yun-Ting Chang Division of Dermatology
The Actual Total Number of Participants Enrolled
50 Stop recruiting
Audit
CRO
Co-Principal Investigator
- Ming-Hsiu Lin Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Hair Loss
Objectives
To evaluate the efficacy and safety of ENERGI-F701 Solution
(0.01% Adenine) in female subjects with hair loss
Test Drug
ENERGI-F701
Active Ingredient
ENERGI-F701
Dosage Form
liquid，Solution
Dosage
1 ml
Endpoints
Primary Endpoints:
Efficacy:
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 Endpoints:
Efficacy:
1. Change of the amount of hair loss at each post-treatment visit,
except Week 12, from baseline (hair loss is defined as the
collection of hairs after combing at the study site)
2. Change of hair thickness and density measured by
phototrichogram at each post-treatment visit from baseline
3. Investigator assessment (Investigator Photographic Assessment
Questionnaire, IPAQ) at each post-treatment visit
4. Change of hair wash/shed hair count at each post-treatment visit
from baseline
5. Change of each score in subject satisfaction evaluated by Female
Hair Loss Quality of Life Questionnaire (FHL-QOL) at each
post-treatment visit from baseline
Safety:
1. Adverse event incidence
2. Findings in physical examination results
3. Net change from baseline in laboratory test results (including
hemoglobin, hematocrit, RBC, platelet, WBC with differential
counts, ANC, AST, ALT, creatinine, BUN, total bilirubin, γGT, Alk-P, and albumin)
4. Net change from baseline in vital signs
5. Skin irritation assessment (pain, tingling, itching), comparing to
the baseline
6. Change in 12-Lead ECG results
Efficacy:
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 Endpoints:
Efficacy:
1. Change of the amount of hair loss at each post-treatment visit,
except Week 12, from baseline (hair loss is defined as the
collection of hairs after combing at the study site)
2. Change of hair thickness and density measured by
phototrichogram at each post-treatment visit from baseline
3. Investigator assessment (Investigator Photographic Assessment
Questionnaire, IPAQ) at each post-treatment visit
4. Change of hair wash/shed hair count at each post-treatment visit
from baseline
5. Change of each score in subject satisfaction evaluated by Female
Hair Loss Quality of Life Questionnaire (FHL-QOL) at each
post-treatment visit from baseline
Safety:
1. Adverse event incidence
2. Findings in physical examination results
3. Net change from baseline in laboratory test results (including
hemoglobin, hematocrit, RBC, platelet, WBC with differential
counts, ANC, AST, ALT, creatinine, BUN, total bilirubin, γGT, Alk-P, and albumin)
4. Net change from baseline in vital signs
5. Skin irritation assessment (pain, tingling, itching), comparing to
the baseline
6. Change in 12-Lead ECG results
Inclution Criteria
(1) Female, aged at least 20 years old (the legal age of majority is 20 years old in Taiwan)
(2) With hair loss over 100 hairs/day (average of the baseline hair wash/shed hair collection)
(3) Willing to avoid hair dying, perming and extension/weaving as well as maintain the same shampoo and hair products used and approximate hair length starting from the first hair wash/shed hair collection and throughout the study
(4) The subject of childbearing potential must show a negative urine or serum pregnancy test at Visit 1
(5) Have signed the written informed consent form
(2) With hair loss over 100 hairs/day (average of the baseline hair wash/shed hair collection)
(3) Willing to avoid hair dying, perming and extension/weaving as well as maintain the same shampoo and hair products used and approximate hair length starting from the first hair wash/shed hair collection and throughout the study
(4) The subject of childbearing potential must show a negative urine or serum pregnancy test at Visit 1
(5) Have signed the written informed consent form
Exclusion Criteria
(1) With alopecia areata or cicatricial alopecia
(2) Have received hair transplant within 6 months prior to Visit 1
(3) Plan to use any other concomitant therapy with approved indication to treat hair loss, regrowth or volume during the study
(4) Have taken any topical or systemic prescription or Over The Counter (OTC) medications approved for treating hair loss, hair regrowth and/or hair volume within 4 weeks prior to Visit 1
(5) Based on the evaluation by the investigator, the subject has taken medication that has caused hair loss or that has high possibility to deteriorate the pre-existing hair loss, with any of the following conditions:
a.Irregular use of medications within 4 weeks prior to Visit 1
b.To initiate or terminate the regular use of medications within 4 weeks prior to Visit 1
c.Subject will also be excluded from the study if she plans to initiate or terminate the regular use of medications during the study (from signing informed consent till End of Treatment (EOT) Visit)
(6) Have received chemotherapy/cytotoxic agents as well as radiation/laser/surgical therapy of the scalp within 6 months prior to Visit 1
(7) Have received hormones for birth control or hormone replacement therapy with any of the following conditions:
a.Irregular use of hormones within 6 months prior to Visit 1
b.To initiate or terminate the regular use of hormones within 6 months prior to Visit 1
c.Subject will also be excluded from the study if she plans to initiate or terminate the regular use of hormones during the study (from signing informed consent till End of Treatment (EOT) Visit).
(8) With known or suspected hypersensitivity to any ingredients of study product or active control
(9) Any of the following hematologic abnormalities:
a.Hemoglobin < 10.0 g/dL
b.ANC < 1,500/μL,
c.Platelets < 75,000 /μL
(10) Any of the following serum chemistry abnormalities:
a.Total bilirubin > 1.5 × ULN,
b.AST or ALT > 3 × ULN,
c.γ-GT > 2.5 × ULN,
d.Alk-P > 2.5 × ULN,
e.Serum albumin < 3 g/dL,
f.Creatinine >1.5 × ULN
g.Any other ≥ Grade 2 laboratory abnormality (based on CTCAE v4.03) (other than those listed above)
(11) Pregnant, lactating, or premenopausal with childbearing potential but not adopting at least one form of birth control from signing informed consent to 30 days after the last dose administration.
Acceptable contraceptive forms include:
a.Established use of oral, injected or implanted hormonal methods of contraception (only for those subjects who are currently using hormonal methods of contraception)
b.Placement of an intrauterine device (IUD) or intrauterine system (IUS)
c.Barrier methods of contraception: condom, or occlusive cap (diaphragm or cervical/vault caps)
(12) Enrollment in any investigational drug trial within 4 weeks prior to Visit 1
(13) With any condition judged by the investigator that entering the trial may be detrimental to the subject or impair the assessment of study results
(2) Have received hair transplant within 6 months prior to Visit 1
(3) Plan to use any other concomitant therapy with approved indication to treat hair loss, regrowth or volume during the study
(4) Have taken any topical or systemic prescription or Over The Counter (OTC) medications approved for treating hair loss, hair regrowth and/or hair volume within 4 weeks prior to Visit 1
(5) Based on the evaluation by the investigator, the subject has taken medication that has caused hair loss or that has high possibility to deteriorate the pre-existing hair loss, with any of the following conditions:
a.Irregular use of medications within 4 weeks prior to Visit 1
b.To initiate or terminate the regular use of medications within 4 weeks prior to Visit 1
c.Subject will also be excluded from the study if she plans to initiate or terminate the regular use of medications during the study (from signing informed consent till End of Treatment (EOT) Visit)
(6) Have received chemotherapy/cytotoxic agents as well as radiation/laser/surgical therapy of the scalp within 6 months prior to Visit 1
(7) Have received hormones for birth control or hormone replacement therapy with any of the following conditions:
a.Irregular use of hormones within 6 months prior to Visit 1
b.To initiate or terminate the regular use of hormones within 6 months prior to Visit 1
c.Subject will also be excluded from the study if she plans to initiate or terminate the regular use of hormones during the study (from signing informed consent till End of Treatment (EOT) Visit).
(8) With known or suspected hypersensitivity to any ingredients of study product or active control
(9) Any of the following hematologic abnormalities:
a.Hemoglobin < 10.0 g/dL
b.ANC < 1,500/μL,
c.Platelets < 75,000 /μL
(10) Any of the following serum chemistry abnormalities:
a.Total bilirubin > 1.5 × ULN,
b.AST or ALT > 3 × ULN,
c.γ-GT > 2.5 × ULN,
d.Alk-P > 2.5 × ULN,
e.Serum albumin < 3 g/dL,
f.Creatinine >1.5 × ULN
g.Any other ≥ Grade 2 laboratory abnormality (based on CTCAE v4.03) (other than those listed above)
(11) Pregnant, lactating, or premenopausal with childbearing potential but not adopting at least one form of birth control from signing informed consent to 30 days after the last dose administration.
Acceptable contraceptive forms include:
a.Established use of oral, injected or implanted hormonal methods of contraception (only for those subjects who are currently using hormonal methods of contraception)
b.Placement of an intrauterine device (IUD) or intrauterine system (IUS)
c.Barrier methods of contraception: condom, or occlusive cap (diaphragm or cervical/vault caps)
(12) Enrollment in any investigational drug trial within 4 weeks prior to Visit 1
(13) With any condition judged by the investigator that entering the trial may be detrimental to the subject or impair the assessment of study results
The Estimated Number of Participants
-
Taiwan
72 participants
-
Global
0 participants
