Ongoing Clinical Trials for Androgenetic Alopecia
Currently, there are 2 clinical trials underway investigating new treatment options for androgenetic alopecia, a common form of hair loss that affects both men and women. These studies are taking place across multiple European countries and are testing different medications to help improve hair growth and density. (Also known as: male pattern baldness, female pattern baldness, male pattern hair loss, female pattern hair loss)
Clinical trial locations
- Germany
- Greece
- Italy
- Poland
- Portugal
- Spain
Study on the Effectiveness and Safety of Oral Minoxidil for Women with Androgenetic Alopecia
This clinical trial is investigating the use of oral minoxidil tablets for women experiencing hormone-related hair loss. The study compares taking a 1 mg minoxidil tablet once daily against a placebo pill, along with a topical solution applied to the scalp. The trial runs for approximately six months, with regular check-ups to monitor hair growth and overall health.
Main inclusion criteria: Women must be at least 18 years old and in generally good health, with no history of heart problems or other significant diseases. They must have been diagnosed with female androgenetic alopecia, which shows as noticeable hair thinning in the central part of the scalp. Hair color must provide enough contrast with the scalp for proper assessment. Women of childbearing potential need to have negative pregnancy tests and agree to use highly effective birth control during the trial and for two weeks after the last treatment. Participants must be willing to maintain the same hairstyle, hair color, and hair care routine throughout the study. They must also be able to attend all scheduled visits, follow the treatment plan, and keep daily diary entries using an electronic device with internet access.
Main exclusion criteria: The trial is only for female patients within the specified age range. People who are part of vulnerable populations cannot participate in this study.
Focus and goals: The main goal of this study is to determine whether oral minoxidil is as effective as the control treatment in promoting hair growth. The primary focus is on measuring the change in the number of thicker, more visible hairs in a specific area of the scalp over the 24-week treatment period. Participants will undergo evaluations at 12 weeks and 24 weeks, including hair counts, measurements of hair width and density, laboratory tests, vital signs monitoring, and physical examinations. A final follow-up visit occurs at week 28 to ensure participant well-being after treatment concludes.
Investigational drugs: The study uses two forms of minoxidil. Oral minoxidil is taken as a 1 mg tablet once daily and works by widening blood vessels to improve blood flow to hair follicles, potentially stimulating hair growth. It is classified as a vasodilator. The study also includes a topical minoxidil solution applied directly to the scalp twice daily for comparison purposes. The goal is to see if the oral form can effectively increase the number of hairs on the scalp over six months compared to the topical solution.
Study on the Effectiveness and Safety of Clascoterone Solution for Treating Male Pattern Hair Loss
This clinical trial is studying a topical solution called clascoterone for treating male pattern hair loss. The study lasts for 12 months in total. During the first 6 months, participants are randomly assigned to use either the clascoterone solution or a vehicle solution without the active ingredient, in a double-blind phase. After this period, all participants use the clascoterone solution for another 6 months in a single-blind phase.
Main inclusion criteria: Participants must be male and at least 18 years old. They must have mild to moderate androgenetic alopecia in the temple and crown areas, rated between III vertex to V on a specific hair loss scale, with a documented history of ongoing hair loss. Participants must be willing to maintain the same hairstyle, hair length, and hair color throughout the study. They must also agree to continue using the same shampoo and hair care products, maintain the same diet and supplement habits, and attend all required clinic visits. Sexually active males who have not had a vasectomy at least 6 months before treatment must agree to use acceptable birth control methods, including condoms and spermicide along with appropriate female contraception methods.
Main exclusion criteria: Only adult males can participate in this study. Females are not eligible. People considered part of vulnerable populations, such as children, pregnant women, or those unable to give consent, cannot join the trial.
Focus and goals: The study aims to evaluate how effective and safe the clascoterone solution is in treating male pattern hair loss. The treatment is applied to the scalp twice daily. During the initial 6-month phase, the study compares the effects of the active treatment against a placebo to ensure unbiased results. At the end of this period, changes in hair coverage are assessed, including measuring the total area of hair coverage and evaluating participants’ own assessments of their hair. The extended 6-month phase allows researchers to evaluate the long-term safety and effectiveness of the treatment. A final evaluation is conducted at the conclusion of the study to assess overall changes in hair coverage and participant satisfaction.
Investigational drugs: Clascoterone is a topical solution applied directly to the scalp. It works by blocking androgen receptors in the skin, which helps reduce the effects of hormones that contribute to hair loss. Clascoterone is classified as an antiandrogen, and its development focuses on providing a non-systemic treatment option for hair loss, meaning it acts locally on the scalp rather than affecting the entire body.
Summary
These two ongoing clinical trials represent current research efforts to develop better treatment options for androgenetic alopecia in both men and women. The studies are being conducted across six European countries: Germany, Greece, Italy, Poland, Portugal, and Spain, with Germany hosting both trials. Each trial takes a different approach: one focuses on oral medication for women, while the other tests a topical solution for men. The trials investigate two different types of medications with distinct mechanisms of action—minoxidil, which improves blood flow to hair follicles, and clascoterone, which blocks androgen receptors. Both studies require participants to commit to maintaining consistent hair care routines and attending regular monitoring visits to properly assess the treatments’ effectiveness and safety over several months.
