Clinical trial • Phase III • Endocrinology|Dermatology

MINOXIDIL for Androgenetic alopecia

Phase III trial of MINOXIDIL for Androgenetic alopecia.

Overview

Trial Therapeutic Area
Endocrinology|Dermatology
Trial Disease
Androgenetic alopecia
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
18-09-2023
First CTIS Authorization Date
22-01-2024

Trial design

Randomised, active group: oral minoxidil 1 mg tablet, once daily (od) + topical vehicle solution 1 ml, twice daily (bid). control group: oral placebo 1 tablet od + topical 2% minoxidil solution 1 ml bid (regaxidil 20 mg/ml topical). placebo group: oral placebo 1 tablet od + topical vehicle solution 1 ml bid. Phase III trial in Italy, Spain, Portugal and others.

Randomised
Yes
Comparator
Active group: oral minoxidil 1 mg tablet, once daily (OD) + topical vehicle solution 1 ml, twice daily (BID). Control group: oral placebo 1 tablet OD + topical 2% minoxidil solution 1 ml BID (Regaxidil 20 mg/ml topical). Placebo group: oral placebo 1 tablet OD + topical vehicle solution 1 ml BID.
Target Sample Size
500
Trial Duration For Participant
196

Eligibility

Recruits 500 Vulnerable population selected. A personally signed and dated informed consent document is required ('A personally signed and dated informed consent document indicating that the patient, has been informed of all pertinent aspects of the clinical trial'). Exclusion criterion: 'In the opinion of the investigator the patient should not participate in the clinical trial, e.g., due to probable non compliance or inability to understand the clinical trial and give adequately informed consent'. No assent procedures or minor/child consent described..

Pregnancy Exclusion
Pregnancy or pregnancy desire during the clinical trial.
Vulnerable Population
Vulnerable population selected. A personally signed and dated informed consent document is required ('A personally signed and dated informed consent document indicating that the patient, has been informed of all pertinent aspects of the clinical trial'). Exclusion criterion: 'In the opinion of the investigator the patient should not participate in the clinical trial, e.g., due to probable non compliance or inability to understand the clinical trial and give adequately informed consent'. No assent procedures or minor/child consent described.

Inclusion criteria

  • {"criterion_text":"- Female patients aged 18 years or older, with general good health (i.e., with no history of cardiovascular disorders, or any other clinically significant disease)\n- Only for patients with micro-dot tattoo: Patient is willing to receive a micro-dot tattoo on the scalp which should help to ensure that the same target area is used in all examinations.\n- Diagnosed with FAGA, based on a discernible decrease in hair density (Sinclair Scale 2 4) (26) in the centroparietal area of the scalp\n- Hair color of patient provides sufficient contrast with the scalp and as confirmed by TrichoLAB Virtual Tattoo® technology at Screening/Visit 1\n- A personally signed and dated informed consent document indicating that the patient, has been informed of all pertinent aspects of the clinical trial\n- Negative serum pregnancy test at Visit 1/Screening and negative urine pregnancy test at Visit 2/Baseline for WOCBP\n- WOCBP[1] must either be permanently sterile[1] or agree to use a highly effective birth control method (failure rate ˂1% per year when used consistently and correctly)[2] throughout the clinical trial and for at least 2 weeks after last administration of IPs. Gestagens with antiandrogen properties (e.g., cyproterone acetate, dienogest) are allowed if treatment is stable since the last 6 months prior to Visit 2/Baseline and if used as contraceptive and planned to be continued throughout the clinical trial duration. For footnotes ([1] and [2]) please refer to the CTP.\n- Patients willing to maintain the same hairstyle (color and hair regimen) throughout the clinical trial. Hair length must remain of sufficient length to not affect determination of hair density and patient should discuss with clinical trial personnel before changing from Visit 2/Baseline\n- Patient is willing to maintain the same depilatory habits and intervals regarding facial or body hair before each visit throughout duration of the clinical trial\n- Patient is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical trial procedures, including daily e diary recordings by the patient using an own electronic device (e.g., tablet, smartphone, personal computer) and an internet connection during the clinical trial"}

Exclusion criteria

  • {"criterion_text":"- Known hypersensitivity or known allergy to minoxidil or to any of the other components of the products\n- Patient has used any of the following topical preparations or procedures on the scalp: a.\tAny topical scalp treatment at Visit 1/Screening and Visit 2/Baseline. b. Topical scalp treatments for hair growth, including minoxidil within the last 6 months prior to Visit 2/Baseline; or hormone therapy, antiandrogens, or other agents that are known to affect hair growth within 12 weeks prior to Visit 2/Baseline. c.\tTopical scalp treatments that might have had ancillary effect on hair growth including, but not limited to, corticosteroids, pimecrolimus, and tacrolimus within the last 4 weeks prior to Visit 2/Baseline. d.\tTopical scalp over the counter (OTC) or cosmetic treatments known or reasonably believed to affect hair growth (e.g., brands such as Maxilene®, Nioxin®, Foltene®, etc.) or hair health or hair growth products with saw palmetto, copper, etc. within the last 4 weeks prior to Visit 2/Baseline. e.\tLight or laser treatment or microneedling of scalp within the last 6 months prior to Visit 2/Baseline. f. Platelet rich plasma (PRP) procedure on the scalp within the last 6 months prior to Visit 2/Baseline\n- Any diagnosed treated or untreated hypertension (or blood pressure values >150 mmHg systolic / >95 mmHg diastolic) as determined at Visit 1/Screening, and/or history/signs of known cardiovascular diseases (including but not limited to cardiac ischemia, congestive heart failure, cardiac arrhythmia), and patients with pathologies or punctual situations that might either be caused by or increase the risk of cardiac disorders.\n- Pregnancy or pregnancy desire during the clinical trial.\n- Participation in the evaluation of any investigational drugs within 30 days, calculated from the first day of the month following the last visit of the previous clinical trial, or 5 half lives (whichever is longer) prior to Visit 2/Baseline.\n- History of drug and alcohol dependency\n- In the opinion of the investigator the patient should not participate in the clinical trial, e.g., due to probable non compliance or inability to understand the clinical trial and give adequately informed consent\n- Close affiliation with the investigator (e.g., a close relative) or persons working at the clinical trial centers or patient is an employee of sponsor\n- Patient is institutionalized because of legal or regulatory order\n- Breastfeeding/Nursing women.\n- Patient has used the following systemic medications or procedures: a. Zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens, streptomycin, penicillamine, benoxaprofen, tamoxifen, phenothiazines, or other vasodilators or antihypertensive agents such as guanethidine and derivatives within the last 12 months prior to Visit 2/Baseline; b. Any 5 alpha reductase medications (i.e., dutasteride, finasteride [Propecia®, etc.] or similar product[s]) within the last 12 months prior to Visit 2/Baseline; c. Retinoid therapy within the last 6 months prior to Visit 2/Baseline; d. Beta blockers, anabolic steroids, or corticosteroids (including intramuscular and intralesional injections) within 12 weeks of Visit 2/Baseline. Inhaled, intranasal, or ocular corticosteroids are allowed if use is stable (defined as doses and frequency unchanged for at least 4 weeks prior to Visit 2/Baseline; e. Drugs with antiandrogenic properties, such as flutamide, cimetidine, or ketoconazole: generally within the last 6 months prior to Visit 2/Baseline; with shorter washout periods applying only for bicalutamide (within 2 months prior to Visit 2/Baseline) and spironolactone (within 1 month prior to Visit 2/Baseline). Gestagens with antiandrogen properties (e.g., cyproterone acetate, dienogest, progesterone) are allowed if treatment has been stable for the last 6 months prior to Visit 2/Baseline; f. Minoxidil within the last 6 months prior to Visit 2/Baseline; g. Prostaglandins and derivates within the last 3 months prior to Visit 2/Baseline. Topical and ocular prostaglandins and its derivates are allowed; h.\tBiotin (>5 mg) within the last 4 weeks prior to Visit 2/Baseline; i. Previous radiation of the scalp and treatment with chemotherapy/systemic cytotoxic agents at any timepoint\n- Patients who had hair transplant surgery at any time\n- Patients with any dermatological disorders of the scalp in the target region at Visit 1/Screening with the possibility of interfering with the application of the IPs or examination method, such as a.\tActive moderate or severe seborrheic dermatitis under chronic treatment, abrasion, actinic keratosis, or inflammatory disorders, or b. any local infection of the skin/subcutaneous tissues of the head within the previous 3 months, or c.\tany documented history of active atopic dermatitis or psoriasis in the scalp within the previous 6 months. d. any other types of alopecia (e.g., alopecia areata or scarring alopecia) at any time point or diffuse telogen effluvium, trichotillomania, or other pathological hair loss conditions/diseases other than AGA in the last 3 months at the discretion of the investigator). e. sunburn, burns, or scarring on the treatment area\n- Patients with shaved scalp\n- Patients with systemic lupus erythematodes or any other systemic autoinflammatory disease\n- Patients with pulmonary hypertension due to mitral stenosis\n- Patients with pheochromocytoma\n- Only for patients with micro-dot tattoo: Known hypersensitivity or known allergy to tattoo ink.\n- Patients who had hair weaving, or any other hair extension methods within the last 6 months prior to Visit 2/Baseline\n- Patients with concurrent use of any occlusive bandages on the treatment area\n- Clinically significant abnormal laboratory values or ECG findings (if applicable) at Visit 1/Screening indicative of physical illness, according to investigator assessment\n- Creatinine above upper limit of normal or eGFR < 60 mL/min/1.73 m², calculated by the Modification of Diet in Renal Disease (MDRD) equation, or abnormal albumin-creatinine ratio in morning urine at Visit 1/Screening\n- Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, or neurological diseases that in the opinion of the investigator may interfere with the aim of the clinical trial\n- Presence of active Mycobacterium tuberculosis (TBC) infection according to patient information. Patients with healed or latent TBC may only participate in the clinical trial if, based on corresponding diagnostic workup according to local practice, no indication for active TBC infection exists according to investigator assessment.\n- Manifest hypothyroidism at Visit 1/Screening (TSH above upper limit normal and T4 below lower limit normal)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The main (primary) efficacy endpoint is the change from Baseline in TAHC at Week 24 (6 months)","definition_or_measurement_approach":"Change from Baseline in Target Area non‑vellus Hair Counts (TAHC) at Week 24 (6 months); measured as difference in TAHC from Baseline to Week 24 as stated in main objectives."}

Secondary endpoints

  • {"endpoint_text":"- Secondary efficacy endpoints: Change from Baseline in TAHC at Week 12\n- Secondary efficacy endpoints: Changes from Baseline in Target Area non vellus Hair Width (TAHW) at Weeks 12 and 24\n- Secondary efficacy endpoints: Changes from Baseline in Target Area non vellus Hair Density (TAHD) at Weeks 12 and 24\n- Secondary efficacy endpoints: Investigator's Global Assessment (IGA) at Weeks 12 and 24\n- Secondary efficacy endpoints: Women’s Androgenetic Alopecia Quality of Life (WAA-QoL) at Weeks 12 and 24\n- Secondary safety endpoints: Overall number of treatment emergent adverse events (TEAEs) (including serious TEAEs) up to the end of the clinical trial (Visit 7/Week 28)\n- Secondary safety endpoints: Change from Baseline in safety laboratory parameters (hematology, clinical chemistry, and urinalysis) to Visit 4/Week 12 and Visit 6/Week 24\n- Secondary safety endpoints: Change from Baseline in vital signs (blood pressure, pulse rate, body temperature) to Visit 4/Week 12, Visit 6/Week 24, and Visit 7/Week 28\n- Secondary safety endpoints: Evaluation of 12-lead electrocardiogram (ECG) to Visit 4/Week 12, Visit 6/Week 24, and Visit 7/Week 28\n- Secondary safety endpoints: Evaluation of physical examination to Visit 4/Week 12, Visit 6/Week 24, and Visit 7/Week 28\n- Secondary safety endpoints: Evaluation of hypertrichosis to Visit 4/Week 12, Visit 6/Week 24, and Visit 7/Week 28","definition_or_measurement_approach":"Endpoints are measured as change from Baseline to specified visits/timepoints (Week 12, Week 24, Week 28) for efficacy measures (TAHC, TAHW, TAHD), investigator assessments (IGA), patient-reported WAA-QoL, and safety assessments include TEAEs count, laboratory parameters, vital signs, 12-lead ECGs, physical examinations and hypertrichosis evaluations at the stated visits."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
500
Recruitment Window Months
26
Consent Approach
Informed consent is provided by the participant: 'A personally signed and dated informed consent document indicating that the patient, has been informed of all pertinent aspects of the clinical trial'. Subject information and ICF documents for adults are available in multiple languages (documents: L1_SIS and ICF adults_EN, _DE, _ES, _PT, _IT). No assent or minor consent procedures are described (adult female participants only).

Methods

  • Online recruitment campaign / landing page (K2_Recruitment Material_Landing page_online campaign_* documents) including print and digital adverts (country-specific versions for IT, ES, PT, DE) as listed in recruitment documents.
  • Pre-screen tools and online campaign process descriptions (documents: K2_Recruitment Material_Online campaign process description; K2_Recruitment Material_pre-screen tool_site 27 to 31).
  • Site-level advertising and referral letters (K2_Recruitment Material_Advert_Referral Letter_* and GP Notification Letter).
  • Use of third-party online recruitment provider powerMedia CRO Services GmbH (role listed as 'Online recruiting services').
  • e-Diary provision to participants by Bioclever 2005 S.L. (listed duty 'e-Diary provider')

Geography

Total Number Of Sites
28
Total Number Of Participants
500

Italy

Earliest CTIS Part Ii Submission Date
12-12-2023
Latest Decision Or Authorization Date
18-06-2025
Processing Time Days
554
Number Of Sites
2
Number Of Participants
20

Sites

Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Dipartimento di Scienze Cliniche Internistiche Anestesiologiche e Cardiovascolari
Contact Person Name
Alfredo Rossi
Contact Person Email
alfredo.rossi@uniroma1.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Dipartimento di Medicina e Chirurgia
Contact Person Name
Bianca Maria Piraccini
Contact Person Email
biancamaria.piraccini@unibo.it

Spain

Earliest CTIS Part Ii Submission Date
15-01-2024
Latest Decision Or Authorization Date
26-06-2025
Processing Time Days
528
Number Of Sites
3
Number Of Participants
50

Sites

Site Name
Institut Medico Ricart
Contact Person Name
Alba Gómez Zubiaur
Contact Person Email
agomezubiaur@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Dermatology Service
Contact Person Name
Andrea Combalia
Contact Person Email
ACOMBALIA@clinic.cat
Site Name
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Contact Person Name
Sergio Vañó
Contact Person Email
j.villanueva@pjaen.com

Portugal

Earliest CTIS Part Ii Submission Date
03-11-2023
Latest Decision Or Authorization Date
16-06-2025
Processing Time Days
590
Number Of Sites
4
Number Of Participants
40

Sites

Site Name
Hospital Cuf Descobertas S.A.
Contact Person Name
Pedro Mendes-Bastos
Site Name
Instituto Dermatológico da Madeira - Dermatologia e Laserterapia
Contact Person Name
Rubina Alves
Contact Person Email
rubinaalves@gmail.com
Site Name
Personal Derma - Clínica Dermatológica & Estética
Contact Person Name
Luis Uva
Contact Person Email
luisuva@hotmail.com
Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Contact Person Name
Ângela Roda

Germany

Earliest CTIS Part Ii Submission Date
06-12-2023
Latest Decision Or Authorization Date
05-11-2025
Processing Time Days
699
Number Of Sites
19
Number Of Participants
390

Sites

Site Name
Siteworks GmbH
Department Name
Practice
Contact Person Name
Karl Hoffmann
Contact Person Email
info@siteworks-research.com
Site Name
Westfaelische Wilhelms-Universitaet Muenster
Department Name
Department of Dermatology
Contact Person Name
Nina Magnolo
Contact Person Email
nina.magnolo@ukmuenster.de
Site Name
Rosenpark Research GmbH
Department Name
Practice
Contact Person Name
Oliver Weirich
Site Name
Goethe University Frankfurt
Department Name
Klinik für Dermatologie, Venerologie und Allergologie
Contact Person Name
Andreas Pinter
Contact Person Email
andreas.pinter@kgu.de
Site Name
Emovis GmbH
Department Name
Study site
Contact Person Name
Saskia Christine Kerschischnik
Contact Person Email
saskia.kerschischnik@emovis.de
Site Name
Hautarztpraxis Dr. Leitz Und Kollegen
Department Name
Dermatological practice
Contact Person Name
Nicolas Leitz
Contact Person Email
nicolas.leitz@tri-derm.de
Site Name
Siteworks GmbH (Karlsruhe)
Department Name
Practice
Contact Person Name
Julia Chevts
Contact Person Email
karlsruhe@siteworks-studien.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Dept. of Dermatology, Venereology and Allergology
Contact Person Name
Ulrike Blume-Peytavi
Contact Person Email
crc-office@charite.de
Site Name
Eurofins bioskin GmbH
Department Name
Research Center for Dermatology
Contact Person Name
Walter Wigger-Alberti
Site Name
Haut-und Lasercentrum Potsdam - Dr. med. Tanja Fischer
Department Name
Practice
Contact Person Name
Tanja Fischer
Contact Person Email
dr.fischer.studien@hlpc.de
Site Name
Klinische Forschung Hamburg GmbH
Department Name
Healthcare
Contact Person Name
Marret Mehrwald
Contact Person Email
lehmpfuhl@kfgn.de
Site Name
Klinische Forschung Schwerin GmbH
Department Name
Healthcare
Contact Person Name
Charlotte von Engelhardt
Contact Person Email
info-schwerin@pratia.com
Site Name
Klinische Forschung Berlin-Mitte GmbH
Department Name
Healthcare
Contact Person Name
Hartmut Tischner
Contact Person Email
info-berlin@pratia.com
Site Name
Klinische Forschung Hannover-Mitte GmbH
Department Name
Healthcare
Contact Person Name
Jan Wagner
Contact Person Email
info-hannover@pratia.com
Site Name
Privatpraxis Dr. Hilton & Partner
Contact Person Name
Rodrigo da Mota
Contact Person Email
study@dr-hilton.de
Site Name
Dr. Niesmann And Dr. Othlinghaus GbR
Department Name
Practice
Contact Person Name
Johannes Niesmann
Site Name
Aesthetik Freiburg GmbH, Dr. med. Mario Bittar
Department Name
Practice
Contact Person Name
Mario Bittar
Contact Person Email
info@aesthetik-freiburg.com
Site Name
Thermalsole und Schwefelbad Bentheim GmbH
Department Name
Practice
Contact Person Name
Athanasios Tsianakas
Site Name
Klinische Forschung Dresden GmbH
Department Name
Healthcare
Contact Person Name
Peter Heymer
Contact Person Email
info-dresden@pratia.com

Sponsor

Primary sponsor

Full Name
Industrial Farmaceutica Cantabria S.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Spain

Contract research organisations

Name
powerMedia CRO Services GmbH
Responsibilities
Online recruiting services
Name
ExCard Research GmbH
Responsibilities
Central electrocardiogram (ECG) services

Third parties

  • {"country":"Germany","full_name":"powerMedia CRO Services GmbH","duties_or_roles":"Online recruiting services","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"ExCard Research GmbH","duties_or_roles":"Central electrocardiogram (ECG) services","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Taxi Travel Ticket S.L.","duties_or_roles":"Travel arrangements for patient to site travels","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Poland","full_name":"Tricholab Sp. z o.o.","duties_or_roles":"Clinical assessment Trichoscopy, Device supply, Technical support","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Spain","full_name":"Distefar Del Sur S.L.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Spain","full_name":"Bioclever 2005 S.L.","duties_or_roles":"e-Diary provider","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Eurofins bioskin GmbH","duties_or_roles":"Multiple laboratory/technical roles (codes provided in record)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"LKF Laboratorium fuer Klinische Forschung GmbH","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"eTMF provider","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Minoxidil 1 mg tablet
Active Substance
MINOXIDIL
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus:1
Starting Dose
1 mg (oral) once daily (OD)
Dose Levels
1 mg
Frequency
Once daily (OD)
Maximum Dose
1.0 mg (maxDailyDoseAmount)
Investigational Product Name
Placebo to Minoxidil 1 mg tablet
Modality
Other
Routes Of Administration
ORAL
Route
ORAL
Starting Dose
1 tablet (oral) once daily (OD) (placebo)
Dose Levels
matching placebo
Frequency
Once daily (OD)
Investigational Product Name
Regaxidil 20 mg/ml solución cutánea
Active Substance
MINOXIDIL
Modality
Small molecule
Routes Of Administration
TOPICAL
Route
TOPICAL
Authorisation Status
prodAuthStatus:2; marketingAuthNumber:57.597 (ES)
Starting Dose
Topical 20 mg/ml solution, 1 ml twice daily (BID) (2% solution)
Dose Levels
20 mg/ml (1 ml per application, 1 ml BID)
Frequency
Twice daily (BID)
Maximum Dose
40 mg (maxDailyDoseAmount)
Investigational Product Name
Placebo to Regaxidil 20 mg/ml solution
Modality
Other
Routes Of Administration
TOPICAL
Route
TOPICAL
Starting Dose
Topical vehicle solution 1 ml twice daily (BID) (placebo)
Dose Levels
matching placebo
Frequency
Twice daily (BID)
Combination Treatment
Yes

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