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Tests treatment safety and results for Androgenetic Alopecia
Official title Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia
ClinicalTrials.gov ID: NCT05888922
What this study is testing
What is Minoxidil Tablets?
Minoxidil Tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for androgenetic alopecia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Female patients aged 18 years or older, with general good health (i.e., with no history of cardiovascular disorders, or any other clinically...
- 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).
You likely can't join 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...
- Patients with any dermatological disorders of the scalp in the target region at Visit 1/Screening with the possibility of interfering with the...
- Active moderate or severe seborrheic dermatitis under chronic treatment, abrasion, actinic keratosis, or inflammatory disorders, or
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- Patient has used any of the following topical preparations or procedures on the scalp:
- 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...
- 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.
- 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...
- Light or laser treatment or microneedling of scalp within the last 6 months prior to Visit 2/Baseline.
- Platelet rich plasma (PRP) procedure on the scalp within the last 6 months prior to Visit 2/Baseline.
- Patient has used the following systemic medications or procedures:
- Zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens, streptomycin, penicillamine, benoxaprofen, tamoxifen, phenothiazines, or other vasodilators or antihypertensive agents such as guanethidine...
- 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.
- Retinoid therapy within the last 6 months prior to Visit 2/Baseline.
- 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...
- Drugs with antiandrogenic properties, such as flutamide, cimetidine, or ketoconazole within the last 6 months prior to Visit 2/Baseline; bicalutamide within 2 months and spironolactone within 1 month prior to Visit...
- Minoxidil within the last 6 months prior to Visit 2/Baseline.
- Prostaglandins and derivates within the last 3 months prior to Visit 2/Baseline. Topical and ocular prostaglandins and its derivates are allowed.
- Biotin (\>5 mg) within the last 4 weeks prior to Visit 2/Baseline.
- Previous radiation of the scalp and treatment with chemotherapy/systemic cytotoxic agents at any timepoint.
- Participation in the evaluation of any investigational drugs within 30 days or 5 half lives (whichever is longer) prior to Visit 2/Baseline, calculated from the first day of the month following the last visit of the...
- History of drug and alcohol dependency.
- 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.
- 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.
- Patient is institutionalized because of legal or regulatory order.
The study team makes the final eligibility decision.
Where it's taking place
- Bad Bentheim, Germany
- Berlin, Germany
- Darmstadt, Germany
- Düsseldorf, Germany
- Frankfurt, Germany
- Freiburg im Breisgau, Germany
- Hamburg, Germany
- Karlsruhe, Germany
- Löhne, Germany
- Münster, Germany
- Potsdam, Germany
- Stuttgart, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bad Bentheim, Germany; Berlin, Germany; Darmstadt, Germany; Düsseldorf, Germany; Frankfurt, Germany; Freiburg im Breisgau, Germany and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.