Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia

NCT05888922 | Not Yet Recruiting Phase 3

• 1 other identifier: P22112a
• Study Type: interventional
• Target: 520
• Locations: 0 countries
• Sites: N/A

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, once/day) and the vehicle solution (vehicle means it looks like the comparator product, but it does not contain an active ingredient, 2 times/day), or
• the placebo tablet (placebo means it looks like the test product, but it does not contain an active ingredient, once/day) and the comparator product (2% minoxidil solution, 2 times/day), or
• the placebo tablet (once/day) and the vehicle solution (2 times/day). 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 (i.e., 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.

Conditions

Androgenetic Alopecia; Female Pattern Baldness

Keywords

Androgenetic alopecia; Female Pattern Baldness; FAGA; Minoxidil

Outcome Measures

Primary Outcomes (1)

• Change in Target Area non vellus Hair Counts (TAHC)

  This is the change in TAHC from Baseline to Week 24 (6 months). A descriptive analysis of the TAHC score at Baseline and Week 24 will be performed by treatment group (active, control and placebo). Also, a descriptive analysis of the change from Baseline to Week 24 (Week 24 - Baseline) will be performed by treatment group (active, control and placebo).

  From baseline to week 24

Study Arms (3)

Active group

EXPERIMENTAL

Oral minoxidil 1 mg (1 tablet, OD) + topical vehicle solution (1 ml, BID)

Drug: Minoxidil Tablets; Drug: Vehicle solution

Control group

ACTIVE COMPARATOR

Oral placebo (1 tablet, OD) + topical 2% Minoxidil solution (1 ml, BID)

Drug: Minoxidil Topical; Drug: Placebo oral tablet

Placebo group

PLACEBO COMPARATOR

oral placebo (1 tablet, OD) + topical vehicle solution (1 ml, BID)

Drug: Placebo oral tablet; Drug: Vehicle solution

Interventions

Minoxidil Tablets DRUG

The clinical trial will use a block randomization scheme to assign those eligible patients to one of the three arms of the study treatment on a 2:2:1 ratio. All patients will be given a kit with oral tablets (active/placebo) 1 tablet to be taken once a day and a topical solution (active comparator/vehicle) to be applied 1 ml twice daily.

Active group

Minoxidil Topical DRUG

The clinical trial will use a block randomization scheme to assign those eligible patients to one of the three arms of the study treatment on a 2:2:1 ratio. All patients will be given a kit with oral tablets (active/placebo) 1 tablet to be taken once a day and a topical solution (active comparator/vehicle) to be applied 1 ml twice daily.

Control group

Placebo oral tablet DRUG

The clinical trial will use a block randomization scheme to assign those eligible patients to one of the three arms of the study treatment on a 2:2:1 ratio. All patients will be given a kit with oral tablets (active/placebo) 1 tablet to be taken once a day and a topical solution (active comparator/vehicle) to be applied 1 ml twice daily.

Control group; Placebo group

Vehicle solution DRUG

The clinical trial will use a block randomization scheme to assign those eligible patients to one of the three arms of the study treatment on a 2:2:1 ratio. All patients will be given a kit with oral tablets (active/placebo) 1 tablet to be taken once a day and a topical solution (active comparator/vehicle) to be applied 1 ml twice daily.

Active group; Placebo group

Eligibility Criteria

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

You may qualify if:

• 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).
• Diagnosed with FAGA, based on a discernible decrease in hair density (Sinclair Scale 2-4) in the centroparietal area of the scalp.
• Hair color of patient provides sufficient contrast with the scalp and as confirmed by TrichoLab Virtual Tattoo® technology at Screening/Visit 1.
• A personally signed and dated informed consent document indicating that the patient, has been informed of all pertinent aspects of the clinical trial.
• Negative serum pregnancy test at Visit 1/Screening and negative urine pregnancy test at Visit 2/Baseline for women of child-bearing potential (WOCBP).
• WOCBP must either be permanently sterile1 or agree to use a highly effective birth control method (failure rate ˂1% per year when used consistently and correctly) 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.
• 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.
• 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.
• 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.

You may not qualify if:

• Known hypersensitivity or known allergy to minoxidil or to any of the other components of the products.
• Pregnancy or pregnancy desire during the clinical trial.
• Breastfeeding/Nursing women.
• 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.
• 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
• Active moderate or severe seborrheic dermatitis under chronic treatment, abrasion, actinic keratosis, or inflammatory disorders, or
• any local infection of the skin/subcutaneous tissues of the head within the previous 3 months, or
• any documented history of active atopic dermatitis or psoriasis in the scalp within the previous 6 months.
• 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).
• Patients who had hair transplant surgery at any time.
• Patients who had hair weaving, or any other hair extension methods within the last 6 months prior to Visit 2/Baseline.
• Clinically significant abnormal laboratory values or ECG findings (if applicable) at Visit 1/Screening indicative of physical illness, according to investigator assessment.
• Both creatinine and eGFR above upper limit of normal at Visit 1/Screening.
• 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.
• Patient has used any of the following topical preparations or procedures on the scalp:

Sponsors & Collaborators

• Industrial Farmacéutica Cantabria, S.A.: lead
• Bioskin GmbH: collaborator
• BioClever 2005 S.L.: collaborator

Related Publications (12)

• Carmina E, Azziz R, Bergfeld W, Escobar-Morreale HF, Futterweit W, Huddleston H, Lobo R, Olsen E. Female Pattern Hair Loss and Androgen Excess: A Report From the Multidisciplinary Androgen Excess and PCOS Committee. J Clin Endocrinol Metab. 2019 Jul 1;104(7):2875-2891. doi: 10.1210/jc.2018-02548.

  PMID: 30785992 BACKGROUND

• Russo PM, Fino E, Mancini C, Mazzetti M, Starace M, Piraccini BM. HrQoL in hair loss-affected patients with alopecia areata, androgenetic alopecia and telogen effluvium: the role of personality traits and psychosocial anxiety. J Eur Acad Dermatol Venereol. 2019 Mar;33(3):608-611. doi: 10.1111/jdv.15327. Epub 2018 Dec 2.

  PMID: 30394586 BACKGROUND

• Olsen EA. Female pattern hair loss. J Am Acad Dermatol. 2001 Sep;45(3 Suppl):S70-80. doi: 10.1067/mjd.2001.117426. No abstract available.

  PMID: 11511856 BACKGROUND

• Famenini S, Slaught C, Duan L, Goh C. Demographics of women with female pattern hair loss and the effectiveness of spironolactone therapy. J Am Acad Dermatol. 2015 Oct;73(4):705-6. doi: 10.1016/j.jaad.2015.06.063. No abstract available.

  PMID: 26369846 BACKGROUND

• Starace M, Orlando G, Alessandrini A, Piraccini BM. Female Androgenetic Alopecia: An Update on Diagnosis and Management. Am J Clin Dermatol. 2020 Feb;21(1):69-84. doi: 10.1007/s40257-019-00479-x.

  PMID: 31677111 BACKGROUND

• Redler S, Messenger AG, Betz RC. Genetics and other factors in the aetiology of female pattern hair loss. Exp Dermatol. 2017 Jun;26(6):510-517. doi: 10.1111/exd.13373.

  PMID: 28453904 BACKGROUND

• Ramos PM, Brianezi G, Martins AC, da Silva MG, Marques ME, Miot HA. Apoptosis in follicles of individuals with female pattern hair loss is associated with perifollicular microinflammation. Int J Cosmet Sci. 2016 Dec;38(6):651-654. doi: 10.1111/ics.12341. Epub 2016 Jun 1.

  PMID: 27163333 BACKGROUND

• Vano-Galvan S, Pirmez R, Hermosa-Gelbard A, Moreno-Arrones OM, Saceda-Corralo D, Rodrigues-Barata R, Jimenez-Cauhe J, Koh WL, Poa JE, Jerjen R, Trindade de Carvalho L, John JM, Salas-Callo CI, Vincenzi C, Yin L, Lo-Sicco K, Waskiel-Burnat A, Starace M, Zamorano JL, Jaen-Olasolo P, Piraccini BM, Rudnicka L, Shapiro J, Tosti A, Sinclair R, Bhoyrul B. Safety of low-dose oral minoxidil for hair loss: A multicenter study of 1404 patients. J Am Acad Dermatol. 2021 Jun;84(6):1644-1651. doi: 10.1016/j.jaad.2021.02.054. Epub 2021 Feb 24.

  PMID: 33639244 BACKGROUND

• Shorter K, Farjo NP, Picksley SM, Randall VA. Human hair follicles contain two forms of ATP-sensitive potassium channels, only one of which is sensitive to minoxidil. FASEB J. 2008 Jun;22(6):1725-36. doi: 10.1096/fj.07-099424. Epub 2008 Feb 7.

  PMID: 18258787 BACKGROUND

• Burton JL, Marshall A. Hypertrichosis due to minoxidil. Br J Dermatol. 1979 Nov;101(5):593-5.

  PMID: 518830 BACKGROUND

• Zappacosta AR. Reversal of baldness in patient receiving minoxidil for hypertension. N Engl J Med. 1980 Dec 18;303(25):1480-1. doi: 10.1056/nejm198012183032516. No abstract available.

  PMID: 7432414 BACKGROUND

• Jimenez-Cauhe J, Saceda-Corralo D, Rodrigues-Barata R, Moreno-Arrones OM, Ortega-Quijano D, Fernandez-Nieto D, Jaen-Olasolo P, Vano-Galvan S. Safety of low-dose oral minoxidil treatment for hair loss. A systematic review and pooled-analysis of individual patient data. Dermatol Ther. 2020 Nov;33(6):e14106. doi: 10.1111/dth.14106. Epub 2020 Sep 7.

  PMID: 32757405 BACKGROUND

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 Officials

• Maria Jose Gómez-Sánchez

  Industrial Farmacéutica Cantabria, S.A.

  STUDY DIRECTOR

Central Study Contacts

Ana López-Ballesteros

CONTACT

+34671778847; ana.lopez@cantabrialabs.es

Maria Jose Gómez-Sánchez

CONTACT

+34647764688; mariajose.gomez@cantabrialabs.es

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: May 25, 2023
• First Posted: June 5, 2023
• Study Start: September 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share