Efficacy and safety of oral minoxidil in women with hormone-imbalanced hair loss

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Industrial Farmaceutica Cantabria S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19], Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

10 Oct 2024 → ongoing

Decision date (initial)

2024-01-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-503383-17-01

ClinicalTrials.gov

NCT05888922

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

a) To demonstrate that active treatment group (oral minoxidil 1 mg [1 tablet, once daily (OD)] + topical vehicle solution [1 ml, BID] is non-inferior to control treatment group (oral placebo [1 tablet, OD] + topical 2% minoxidil solution 1 ml, BID]) in change of Target Area non‑vellus Hair Counts (TAHC) from Baseline to Week 24 (6 months).

b) To demonstrate superiority of active treatment group over placebo treatment group (oral placebo [1 tablet, OD] + topical vehicle solution [1 ml, BID]) in change of TAHC from Baseline to Week 24 (6 months).

Secondary objectives 1

1. The secondary objective is to support the safety profile of oral minoxidil 1 mg OD

Conditions and MedDRA coding

Female androgenetic alopecia

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Federal Institute For Drugs And Medical Devices

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. 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)
2. Diagnosed with FAGA, based on a discernible decrease in hair density (Sinclair Scale 2 4) (26) in the centroparietal area of the scalp
3. Hair color of patient provides sufficient contrast with the scalp and as confirmed by TrichoLAB Virtual Tattoo® technology at Screening/Visit 1
4. A personally signed and dated informed consent document indicating that the patient, has been informed of all pertinent aspects of the clinical trial
5. Negative serum pregnancy test at Visit 1/Screening and negative urine pregnancy test at Visit 2/Baseline for WOCBP
6. 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.
7. 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
8. 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
9. 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
10. 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.

Exclusion criteria 25

1. Known hypersensitivity or known allergy to minoxidil or to any of the other components of the products
2. Patients who had hair transplant surgery at any time
3. Patients who had hair weaving, or any other hair extension methods within the last 6 months prior to Visit 2/Baseline
4. Patients with concurrent use of any occlusive bandages on the treatment area
5. Clinically significant abnormal laboratory values or ECG findings (if applicable) at Visit 1/Screening indicative of physical illness, according to investigator assessment
6. 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
7. 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
8. 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.
9. Manifest hypothyroidism at Visit 1/Screening (TSH above upper limit normal and T4 below lower limit normal)
10. Patient has used any of the following topical preparations or procedures on the scalp: a. Any 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. Topical 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. Topical 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. Light 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
11. 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.
12. Pregnancy or pregnancy desire during the clinical trial.
13. 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.
14. History of drug and alcohol dependency
15. 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
16. 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
17. Patient is institutionalized because of legal or regulatory order
18. Breastfeeding/Nursing women.
19. 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. Biotin (>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
20. 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. Active 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. any 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
21. Patients with shaved scalp
22. Patients with systemic lupus erythematodes or any other systemic autoinflammatory disease
23. Patients with pulmonary hypertension due to mitral stenosis
24. Patients with pheochromocytoma
25. Only for patients with micro-dot tattoo: Known hypersensitivity or known allergy to tattoo ink.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The main (primary) efficacy endpoint is the change from Baseline in TAHC at Week 24 (6 months)

Secondary endpoints 11

1. Secondary efficacy endpoints: Change from Baseline in TAHC at Week 12
2. Secondary efficacy endpoints: Changes from Baseline in Target Area non vellus Hair Width (TAHW) at Weeks 12 and 24
3. Secondary efficacy endpoints: Changes from Baseline in Target Area non vellus Hair Density (TAHD) at Weeks 12 and 24
4. Secondary efficacy endpoints: Investigator's Global Assessment (IGA) at Weeks 12 and 24
5. Secondary efficacy endpoints: Women’s Androgenetic Alopecia Quality of Life (WAA-QoL) at Weeks 12 and 24
6. 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)
7. 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
8. 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
9. Secondary safety endpoints: Evaluation of 12-lead electrocardiogram (ECG) to Visit 4/Week 12, Visit 6/Week 24, and Visit 7/Week 28
10. Secondary safety endpoints: Evaluation of physical examination to Visit 4/Week 12, Visit 6/Week 24, and Visit 7/Week 28
11. Secondary safety endpoints: Evaluation of hypertrichosis to Visit 4/Week 12, Visit 6/Week 24, and Visit 7/Week 28

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Industrial Farmaceutica Cantabria S.A.

Sponsor organisation

Industrial Farmaceutica Cantabria S.A.

Address

Barrio Solia N 30, Liano Liano

City

Villaescusa

Postcode

39690

Country

Spain

Scientific contact point

Organisation

Industrial Farmaceutica Cantabria S.A.

Contact name

Ana López Ballesteros

Public contact point

Organisation

Industrial Farmaceutica Cantabria S.A.

Contact name

Ana López Ballesteros

Third parties 9

Locations

4 EU/EEA countries · 30 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 44 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications