Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05888922
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-01
First Post:
2023-05-25
Brief Title:
Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia
Sponsor:
Industrial Farmacéutica Cantabria SA
Organization:
Industrial Farmacéutica Cantabria SA
Study Overview
Official Title:
International Phase III Multi Center Randomized Double Blind Placebo and Active Controlled and Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of Oral Minoxidil 1 mg in Female Patients With Androgenetic Alopecia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn about oral minoxidil 1mg in the treatment of women with androgenetic alopecia a type of hormone-imbalanced hair loss
The main questions to answer are to know about that minoxidil 1mg is as effective as minoxidil 2 topical solution comparator product and is more effective than placebo and to ensure treatment with oral minoxidil is safe
Participants will be assigned randomly to receive one of the following treatment combinations
the test product oral minoxidil 1 mg onceday and the vehicle solution vehicle means it looks like the comparator product but it does not contain an active ingredient 2 timesday or
the placebo tablet placebo means it looks like the test product but it does not contain an active ingredient onceday and the comparator product 2 minoxidil solution 2 timesday or
the placebo tablet onceday and the vehicle solution 2 timesday
The clinical trial will take up to 36 weeks During this time patients will come to the clinical trial centre for 5 times for examinations and will be called by phone twice At the visits the following examinations will be performed photos of the hair will be taken to determine hair density assessment of changes in scalp hair growth measurement of blood pressure pulse and body temperature a physical examination blood withdrawal to determine any abnormalities in the blood urine sampling and analysis performance of ECG and evaluation of hypertrichosis ie excessive hair growth over the body Furthermore patients will be asked daily whether they had experienced any side effects or took any new medications or changed the dose of a known medication or underwent any medical procedure Also women of childbearing potential must undergo pregnancy tests in blood and urine
The main questions to answer are to know about that minoxidil 1mg is as effective as minoxidil 2 topical solution comparator product and is more effective than placebo and to ensure treatment with oral minoxidil is safe
Participants will be assigned randomly to receive one of the following treatment combinations
the test product oral minoxidil 1 mg onceday and the vehicle solution vehicle means it looks like the comparator product but it does not contain an active ingredient 2 timesday or
the placebo tablet placebo means it looks like the test product but it does not contain an active ingredient onceday and the comparator product 2 minoxidil solution 2 timesday or
the placebo tablet onceday and the vehicle solution 2 timesday
The clinical trial will take up to 36 weeks During this time patients will come to the clinical trial centre for 5 times for examinations and will be called by phone twice At the visits the following examinations will be performed photos of the hair will be taken to determine hair density assessment of changes in scalp hair growth measurement of blood pressure pulse and body temperature a physical examination blood withdrawal to determine any abnormalities in the blood urine sampling and analysis performance of ECG and evaluation of hypertrichosis ie excessive hair growth over the body Furthermore patients will be asked daily whether they had experienced any side effects or took any new medications or changed the dose of a known medication or underwent any medical procedure Also women of childbearing potential must undergo pregnancy tests in blood and urine
Detailed Description:
This is a phase III multi center randomized double blind placebo and active controlled parallel group design clinical trial to evaluate the efficacy and safety of oral minoxidil 1 mg for the treatment of AGA in female patients aged 18 years or older with general good health ie with no history of cardiovascular disorders or any other clinically significant disease and without any dermatological disorders eg of the scalp in the target region at Visit 1Screening with the possibility of interfering with the application of the IPs or examination method
Patients must show and have a history of hair density reduction in the centroparietal area of the scalp as classified by the Sinclair Scale Sinclair Scale 2-4
It is planned that approximately 520 adult female patients with FAGA from 20 trial centers across 4 countries Germany Spain Italy and Portugal will enter the clinical trial
Eligible patients will be randomly assigned in a ratio 221 active control placebo to one of the following 3 treatment groups
1 Active group oral minoxidil 1 mg 1 tablet once daily OD topical vehicle solution 1 ml twice daily BID
2 Control group oral placebo 1 tablet OD topical 2 minoxidil solution 1 ml BID
3 Placebo group oral placebo 1 tablet OD topical vehicle solution 1 ml BID
At Visit 2Baseline patients will receive three boxes containing 5 blister packs of 10 tablets each a total of 50 tablets and 4 bottles of IP solution containing 60 ml of 2 minoxidil solution each to cover 12 weeks 7 days of clinical trial treatment The patients will be instructed how to apply the IPs The first topical IP treatment will be performed under supervision at the clinical trial center and then treatments will be performed by the patients at home also the intake of the first tablet as follows Patients will administer the assigned IPs daily for 6 months-one tablet orally OD in the eveningat night preferably before going to bed to minimize anti hypertensive side effects and 2 ml assigned solution topically to the scalp BID two topical applications of 1 ml each to be performed at least 8 hours apart Each patient will be requested to record date and time of treatments in an electronic patient dosing diary hereinafter called electronic diary e-diary At the next planned clinical trial center visit Visit 4Week 12 the patients will receive a new batch of clinical trial treatment for the next 12 weeks
The clinical trial consists of a screening period up to approximately 8 weeks Week 8 to Day -2 a 6 month treatment period Week 0 to 24 and a 4 week follow up period Week 25 to 28
It is planned to have five clinical trial center visits Visit 1Screening Visit 2Baseline Visit 4Week 12 Visit 6Week 24 and Visit 7Week 28 and two safety phone calls Visit 3Week 4 and Visit 5Week 18 during the course of the clinical trial unscheduled visits may be needed per the discretion of the investigator Efficacy and safety will be evaluated and compared among the three treatment groups
The duration of clinical trial participation for each patient will be approximately up to 36 weeks
At the screening visit the clinical trial requirements and procedures will be reviewed Written informed consent will be obtained prior to the initiation of any clinical trial related procedures including washout Once informed consent has been signed the patient will be assigned a patient number The suitability of the patient hair color sufficient contrast with the scalp for re-detection of the target area will be assessed by means of the TrichoLab Virtual Tattootechnology which includes the taking of two microphotographs
If applicable qualified patients can washout from prohibited medications or treatments prior to Visit 2Baseline after obtaining written informed consent Patients must return to the clinical trial center after washout for completion of screening procedures
The following screening procedures must take place up to within 8 weeks of Visit 2Baseline
Demographics inclusionsexclusion criteria relevant medical and relevant surgical history of the past 5 years and prior as well as concomitant medications and therapies of the last 12 months will be reviewed The patients FAGA will be classified using the Sinclair Scale A brief physical examination vital signs blood pressure pulse rate body temperature height and weight safety laboratory tests hematology clinical chemistry and urinalysis serum pregnancy test only for women of childbearing potential WOCBP and 12 lead ECG will be performed AEs will be recorded as applicable Preliminary patient eligibility will be assessed and if applicable the patient will be scheduled for Visit 2Baseline
During the clinical trial safety will be assessed through physical examination vital signs weight 12 lead ECG and safety laboratory tests hematology clinical chemistry and urinalysis at each clinical trial center visit except for safety laboratory which will not be performed at Visit 7Week 28
Hypertrichosis evaluation will be performed at Visit 2Baseline Visit 4Week 12 Visit 6Week 24 end of treatment EoTearly termination visit ETV and Visit 7Week 28
AEs as well as concomitant medication and procedures will be documented from the time point the patient has signed the informed consent form ICF until the end of clinical trial
For all WOCBP a urine pregnancy test will be performed at Visit 2Baseline Visit 4Week 12 and Visit 6Week 24
During the clinical trial efficacy will be determined based on quantitative hair measurements of Target Area non-vellus Hair Counts TAHC Target Area non vellus Hair Width TAHW and Target Area non vellus Hair Density TAHD at each clinical trial center visit except for Visit 1Screening and Visit 7Week 28 TAHC TAHW and TAHD will be determined by using TrichoLAB Hair-to-hair Matching technology and digital image analysis
In addition hair growth assessments will be performed by the investigator at Visit 4Week 12 and Visit 6Week 24 Investigators Global Assessment IGA 7 point scale using the standardized approved global photo of the patients scalp taken at Visit 2Baseline Furthermore the patients quality of life will be assessed by means of a patient self-questionnaire Womens Androgenetic Alopecia Quality of Life WAA QoL at Visit 2Baseline Visit 4Week 12 and Visit 6Week 24
Statistical analyses will be conducted based on the available data without using techniques for inputting missing values but describing the number of missing values for each analysis
All statistical tests will be performed at a significance level of α 001 unless specifically stated otherwise
Prior to the database closure a statistical analysis plan SAP will be approved in which the whole strategy of data analysis will be described in detail
Patients must show and have a history of hair density reduction in the centroparietal area of the scalp as classified by the Sinclair Scale Sinclair Scale 2-4
It is planned that approximately 520 adult female patients with FAGA from 20 trial centers across 4 countries Germany Spain Italy and Portugal will enter the clinical trial
Eligible patients will be randomly assigned in a ratio 221 active control placebo to one of the following 3 treatment groups
1 Active group oral minoxidil 1 mg 1 tablet once daily OD topical vehicle solution 1 ml twice daily BID
2 Control group oral placebo 1 tablet OD topical 2 minoxidil solution 1 ml BID
3 Placebo group oral placebo 1 tablet OD topical vehicle solution 1 ml BID
At Visit 2Baseline patients will receive three boxes containing 5 blister packs of 10 tablets each a total of 50 tablets and 4 bottles of IP solution containing 60 ml of 2 minoxidil solution each to cover 12 weeks 7 days of clinical trial treatment The patients will be instructed how to apply the IPs The first topical IP treatment will be performed under supervision at the clinical trial center and then treatments will be performed by the patients at home also the intake of the first tablet as follows Patients will administer the assigned IPs daily for 6 months-one tablet orally OD in the eveningat night preferably before going to bed to minimize anti hypertensive side effects and 2 ml assigned solution topically to the scalp BID two topical applications of 1 ml each to be performed at least 8 hours apart Each patient will be requested to record date and time of treatments in an electronic patient dosing diary hereinafter called electronic diary e-diary At the next planned clinical trial center visit Visit 4Week 12 the patients will receive a new batch of clinical trial treatment for the next 12 weeks
The clinical trial consists of a screening period up to approximately 8 weeks Week 8 to Day -2 a 6 month treatment period Week 0 to 24 and a 4 week follow up period Week 25 to 28
It is planned to have five clinical trial center visits Visit 1Screening Visit 2Baseline Visit 4Week 12 Visit 6Week 24 and Visit 7Week 28 and two safety phone calls Visit 3Week 4 and Visit 5Week 18 during the course of the clinical trial unscheduled visits may be needed per the discretion of the investigator Efficacy and safety will be evaluated and compared among the three treatment groups
The duration of clinical trial participation for each patient will be approximately up to 36 weeks
At the screening visit the clinical trial requirements and procedures will be reviewed Written informed consent will be obtained prior to the initiation of any clinical trial related procedures including washout Once informed consent has been signed the patient will be assigned a patient number The suitability of the patient hair color sufficient contrast with the scalp for re-detection of the target area will be assessed by means of the TrichoLab Virtual Tattootechnology which includes the taking of two microphotographs
If applicable qualified patients can washout from prohibited medications or treatments prior to Visit 2Baseline after obtaining written informed consent Patients must return to the clinical trial center after washout for completion of screening procedures
The following screening procedures must take place up to within 8 weeks of Visit 2Baseline
Demographics inclusionsexclusion criteria relevant medical and relevant surgical history of the past 5 years and prior as well as concomitant medications and therapies of the last 12 months will be reviewed The patients FAGA will be classified using the Sinclair Scale A brief physical examination vital signs blood pressure pulse rate body temperature height and weight safety laboratory tests hematology clinical chemistry and urinalysis serum pregnancy test only for women of childbearing potential WOCBP and 12 lead ECG will be performed AEs will be recorded as applicable Preliminary patient eligibility will be assessed and if applicable the patient will be scheduled for Visit 2Baseline
During the clinical trial safety will be assessed through physical examination vital signs weight 12 lead ECG and safety laboratory tests hematology clinical chemistry and urinalysis at each clinical trial center visit except for safety laboratory which will not be performed at Visit 7Week 28
Hypertrichosis evaluation will be performed at Visit 2Baseline Visit 4Week 12 Visit 6Week 24 end of treatment EoTearly termination visit ETV and Visit 7Week 28
AEs as well as concomitant medication and procedures will be documented from the time point the patient has signed the informed consent form ICF until the end of clinical trial
For all WOCBP a urine pregnancy test will be performed at Visit 2Baseline Visit 4Week 12 and Visit 6Week 24
During the clinical trial efficacy will be determined based on quantitative hair measurements of Target Area non-vellus Hair Counts TAHC Target Area non vellus Hair Width TAHW and Target Area non vellus Hair Density TAHD at each clinical trial center visit except for Visit 1Screening and Visit 7Week 28 TAHC TAHW and TAHD will be determined by using TrichoLAB Hair-to-hair Matching technology and digital image analysis
In addition hair growth assessments will be performed by the investigator at Visit 4Week 12 and Visit 6Week 24 Investigators Global Assessment IGA 7 point scale using the standardized approved global photo of the patients scalp taken at Visit 2Baseline Furthermore the patients quality of life will be assessed by means of a patient self-questionnaire Womens Androgenetic Alopecia Quality of Life WAA QoL at Visit 2Baseline Visit 4Week 12 and Visit 6Week 24
Statistical analyses will be conducted based on the available data without using techniques for inputting missing values but describing the number of missing values for each analysis
All statistical tests will be performed at a significance level of α 001 unless specifically stated otherwise
Prior to the database closure a statistical analysis plan SAP will be approved in which the whole strategy of data analysis will be described in detail
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None