A 6-Month Phase 3, Multicenter, Prospective, Randomized, Double-Blind, Vehicle-Controlled Study, to Evaluate the Efficacy and Safety of Topically Applied Clascoterone (Cortexolone 17α-Propionate) Solution for the Treatment of Androgenetic Alopecia in Males, Followed by a 6-Month Single-Blind Treatment with Clascoterone or Vehicle BID Solution (SCALP 2)
This research is looking into a new treatment for male-pattern baldness, which is also known as androgenetic alopecia. The treatment is a gel called Clascoterone solution. For the first 6 months, some men will use the Clascoterone gel and others will use a dummy gel (which looks and feels the same but contains no active medicine). This helps us see if the new gel really works better than nothing. We will be checking how much hair grows back and if there are any side effects. After this, all men will use either the active gel or the dummy gel for another 6 months without knowing which one they have. The aim is to find out if Clascoterone solution is an effective and safe way to treat hair loss in men.
At a glance
What is this study about?
This study is investigating a new treatment for a common condition called male-pattern baldness, or androgenetic alopecia. This is a type of hair loss that affects men, often causing a receding hairline and thinning on the top of the head. The new treatment being tested is a gel called Clascoterone solution, which is applied directly to the scalp.
The main goal of this study is to see how well the Clascoterone gel works to help hair grow back and if it is safe for men to use. Researchers want to find out if men who use this new gel see a real improvement in the amount of hair they have compared to men who use a dummy gel (called a 'vehicle' solution). They will also be looking at how happy men are with their hair and the treatment itself.
This is a 'Phase 3' study, which means it's one of the final steps before a new treatment can be considered for wider use. It's designed to confirm the results from earlier studies and provide a lot of information on its effectiveness and safety over a longer period.
Key takeaways
- This study is for men with male-pattern baldness.
- It tests a new gel called Clascoterone solution applied to the scalp.
- The study lasts 12 months, with regular clinic visits.
- You might receive the active gel or a dummy gel (placebo).
- The main goals are to check hair growth and safety.
- Your contribution helps research into new hair loss treatments.
Who may be eligible?
This study is specifically for men who are experiencing male-pattern baldness. You must be at least 18 years old to take part, and there is no upper age limit, so older men are also welcome to join if they meet all the other requirements.
There will be other detailed health checks and specific types of hair loss patterns that we will be looking for to ensure participants are a good fit for this particular study. These checks are important to make sure the study results are clear and that it's safe for you to take part.
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 male?
- Are you 18 years old or older?
- Do you have male-pattern baldness (androgenetic alopecia)?
- Are you willing to apply a gel to your scalp twice a day for 12 months?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you join this study, it will last for a total of 12 months. For the first 6 months, you will be randomly given either the active Clascoterone gel or a dummy gel (vehicle solution) to apply to your scalp twice a day. You won't know which one you're using, and neither will your study doctor. This is called 'double-blind'. For the next 6 months, you will continue to apply a gel twice a day, but this time only you won't know if it's the active drug or the dummy solution (this is 'single-blind').
Throughout the study, you will have regular visits to the clinic. During these visits, the study team will check your hair growth, take pictures, and ask you questions about your hair and how you feel about your treatment. They will also check for any side effects and ensure your general health is good. The main things we'll be measuring are how much your hair has grown at 3 and 6 months, and how you feel about your hair coverage at 6 months.
Potential risks and benefits
Locations (2)
- —UnverifiedGermany
- —UnverifiedPoland
Common questions
What is 'male-pattern baldness'?
It's a common type of hair loss in men, often causing a receding hairline and thinning at the top of the head.
What is the new treatment being tested?
It's a gel called Clascoterone solution, which you apply directly to your scalp.
What is a 'dummy gel'?
It's a gel that looks and feels like the real treatment but doesn't contain any active medicine. It helps us compare the effects.
How long will the study last?
The study will last for a total of 12 months.
Will I know if I'm getting the real treatment or the dummy gel?
For the first six months, neither you nor the doctors will know. For the next six months, only the doctors will know.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.