RecruitingPHASE3INTERVENTIONAL

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

This study wants to find out if taking a 1mg minoxidil tablet every day is a safe and effective way to treat a common type of female hair loss called androgenetic alopecia. Researchers will compare this tablet to a 2% minoxidil solution that you put on your skin, and also to a dummy tablet or cream (a placebo) that contains no active medicine. The main goals are to see if the tablet works as well as the skin solution, or even better than the dummy treatment, and to make sure it's safe for patients. The study lasts about 36 weeks and involves different groups getting various combinations of these treatments.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Industrial Farmacéutica Cantabria, S.A.

Enrolment target

520

Start

17 Oct 2024

Estimated completion

01 Nov 2026

Androgenetic Alopecia Female Pattern Baldness

What is this study about?

This study is about a type of hair loss common in women, called androgenetic alopecia. It's often linked to hormones. Researchers want to see if a daily 1mg tablet of minoxidil can help grow hair and make it thicker. Minoxidil is already used in a solution you put on your scalp, and this study aims to find out if a tablet form is just as helpful, or even more so, for this kind of hair loss.

To do this, the study will compare a daily minoxidil tablet against two other treatments. One is the familiar 2% minoxidil solution applied to the skin. The other is a "placebo," which looks exactly like the real medicine but has no active ingredients. This helps researchers understand if any changes are truly due to the minoxidil or something else.

Ultimately, the main goal is to understand if the minoxidil tablet is both effective and safe for women with this type of hair loss. The study is a "Phase III" trial, which means it's a larger study designed to confirm the results of earlier, smaller studies before a new treatment can be considered for wider use.

Key takeaways

This study is testing a minoxidil tablet for female hair loss.
It compares the tablet to a skin solution and a dummy treatment.
The study lasts about 36 weeks and requires regular visits and checks.
You won't know if you're getting the active drug or a placebo.
You must be a woman aged 18 or over with specific hair loss symptoms and generally good health.

Who may be eligible?

This study is looking for women aged 18 or older who are generally healthy. You would need to have been diagnosed with female androgenetic alopecia, which means a noticeable thinning of hair, particularly on the top and crown of your head, as described by a specific hair loss scale.

It's important that you don't have any serious health problems, especially heart conditions, or any skin conditions on your scalp that might interfere with the study. If you could become pregnant, you'll need to have negative pregnancy tests and agree to use highly effective birth control throughout the study and for a short time afterwards. Also, your hair colour needs to stand out enough against your scalp for photos to be taken easily.

Finally, you should be willing to keep your hairstyle and hair care routine the same during the study, as well as your body hair removal habits. You'd also need to attend all scheduled appointments and follow the study instructions carefully.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or older?
Have you been diagnosed with female pattern hair loss (androgenetic alopecia) on your scalp?
Are you generally healthy, without heart problems or other significant illnesses?
If you can get pregnant, are you willing to use effective birth control throughout the study?
Are you able to attend regular appointments and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last up to 36 weeks (about 8 to 9 months). You'll be randomly placed into one of three groups. One group will take the minoxidil tablet and use a dummy skin solution. A second group will take a dummy tablet and use the 2% minoxidil skin solution. The third group will take a dummy tablet and use a dummy skin solution.

You'll visit the study centre 5 times during this period for check-ups and observations. There will also be 2 phone calls. At your visits, doctors will take photos of your hair to check for growth, measure your blood pressure, pulse, and body temperature. You'll also have a general health check, blood tests, urine tests, and an ECG (heart tracing). They will also look for any unwanted hair growth on your body. You'll be asked daily to record any side effects, new medications, or procedures. If you could become pregnant, you'll have regular pregnancy tests.

Potential risks and benefits

Participating in this study might mean you see an improvement in your hair loss if the minoxidil tablet works for you. You'll also receive careful medical monitoring throughout the study, which is a benefit. However, like all medications, minoxidil can have side effects, such as unwanted hair growth elsewhere on the body or changes in blood pressure. The dummy treatments (placebos) have no active ingredients, so they carry no drug-related risks, but also no direct benefits for hair growth. You have the right to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (13)

Fachklinik Bad Bentheim Klinisches Studienzentrum
Verified postcode
Bad Bentheim, Germany· Recruiting
CRC - Charité Universitätsmedizin Berlin Clinical Research Center for Hair and Skin Science
Verified postcode
Berlin, Germany· Recruiting
emovis by Futuremeds GmbH
Verified postcode
Berlin, Germany· Recruiting
Rosenpark Reasearch GmbH
Verified postcode
Darmstadt, Germany· Not yet recruiting
Privatpraxis Dr. Hilton & Partner
Verified postcode
Düsseldorf, Germany· Terminated
Klinik für Dermatologie, Venerologie und Allergologie - Universitätsmedizin Frankfurt
Verified postcode
Frankfurt, Germany· Recruiting
Dermaticum -Dr. med. Mario Bittar und Kollegen
Verified postcode
Freiburg im Breisgau, Germany· Recruiting
Eurofins bioskin - Research Center Dermatology
Verified postcode
Hamburg, Germany· Recruiting
Klinische Forschung Karlsruhe GmbH
Verified postcode
Karlsruhe, Germany· Recruiting
Siteworks - Prüfzentrum Lohne
Verified postcode
Löhne, Germany· Active not recruiting
Zentrale Studienkoordination für innovative Dermatologie (ZiD) Klinik für Hautkrankheiten Universitätsklinikum Münster (UKM)
Verified postcode
Münster, Germany· Withdrawn
Haut-und Lasercentrum - Dr. Tanja Fischer und Kollegen
Verified postcode
Potsdam, Germany· Recruiting

Common questions

What is androgenetic alopecia?

It's a common type of hair loss in women, often called female pattern baldness, which is thought to be linked to hormones.

What is a 'placebo'?

A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. It helps researchers compare how well the actual medicine works.

How long will the study last?

The study will last for up to 36 weeks, which is about 8 to 9 months.

Will I know if I'm getting the real medicine or the dummy treatment?

No, this is a 'double-blind' study, meaning neither you nor your doctor will know which treatment you are receiving until after the study is over. This helps keep the results fair.

What kind of tests will I have during the study?

You'll have hair photos, blood tests, urine tests, ECGs, and general health checks, including blood pressure and temperature measurements.

How to find out more

Ana López-Ballesteros

ana.lopez@cantabrialabs.es +34671778847 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.