Breezula® Phase 3 Clinical Trials for Male Pattern Hair Loss Begin

Cosmo Pharmaceuticals recently announced the start of two multicenter phase 3 clinical trials for its higher-strength version of clascoterone, an androgen receptor inhibitor they’ve named Breezula®. This topical androgen receptor-blocking drug started patient recruitment at the end of June 2023. Both studies will likely be completed in early 2025.

What Is Breezula®?

Breezula® is the brand name of Cosmo Pharmaceutical’s topical dihydrotestosterone (DHT) blocker that is used to treat pattern hair loss. The active ingredient in Breezula® is clascoterone, which is chemically known as Cortexolone 17α-Propionate. (1)

Breezula® vs. Winlevi® Ingredients

Clascosterone is also the active ingredient in Cosmo Pharmaceutical’s topical acne medication, Winlevi®.  This medication received FDA approval for use in males and females in August 2020. The primary difference between Winlevi® and Breezula® is the concentration of clascoterone in these medications. Winlevi contains 1 percent clascoterone, while the version of Breezula® being tested in the phase 3 clinical trials has 5 percent clascoterone. (2,3)

Is Breezula® for Both Men and Women?

Breezula® is a hair loss drug that has been tested for both male and female androgenetic alopecia. However, Cosmo Pharmaceuticals is currently only conducting clinical trials for male pattern hair loss. (2) In September 2021, they reported that twice-daily application of 5 percent Breezula® was effective in improving terminal hair growth – but only in women under 30 years of age. It’s unclear if or when further Breezula® clinical trials for women will happen. (5) 

When Will Breezula® Be Available?

Cosmo Pharmaceuticals is attempting to make Breezula® the first new medication to be FDA-approved for androgenetic alopecia in nearly 30 years. If current trials go well, Breezula® for hair loss could be approved for use in men in 2026. (4) 

Breezula® Phase 3 Clinical Trials

Cosmo Pharmaceuticals recently launched two identical phase 3 clinical trials for Breezula: SCALP1 and SCALP2. Both studies have two 6-month stages. The first 6-month stage is a prospective, randomized, double-blind, vehicle-controlled study that is designed to determine 5 percent Breezula’s safety and efficacy when used twice a day.  The study will explore changes in non-vellus hair growth after 3 and 6 months, as well as the participants’ assessment of their scalp coverage and satisfaction with the treatment. (2,4,5)

In this first stage, neither study participants nor doctors will know which participants are assigned to use Breezula® or the placebo drug. Participants will have to attend five clinic visits and schedule two follow-up phone calls during this part of the clinical trial. Those who respond to the drug will be invited to continue to the second part of the clinical trial. (6,7)

The second 6-month stage is designed as a single-blind treatment with either 5 percent Breezula® or a placebo solution (the vehicle used to deliver clascoterone). At this point, the clinical trial investigators will know which treatment they are giving to patients, but the patients will remain unaware. Participants must attend two more clinic visits during this portion of the clinical trial. Additionally, all participants are required to attend an end-of-study clinic visit when they finish the clinical trial or if they discontinue the drug. (6,7)

Breezula® Phase 2 Results & Dosing

If you’ve been following Breezula® results, you’ll recall that its phase 2 clinical trial reported significant improvements in hair growth. Applying a 7.5 percent concentration of this solution twice a day produced the best results. Based on these results, Cosmo Pharmaceuticals selected a 75 mg twice-daily dosage for their phase 3 study. (8,9)

In the Breezula® phase 3 clinical trials, you’ll notice that study participants are applying a 5 percent concentration of Breezula®  twice daily. (6,7) Not to worry, though – they haven’t reduced Breezula’s concentration. 

According to Hazel Winchester, Cosmo Pharmaceutical’s Head of Investor Relations, the “delivery of the 1.5 milliliter dose of 5 percent twice a day [solution] provides the same daily dose (150 milligrams) as the 1 milliliter dose of 7.5 percent twice a day [solution]. This may enable the subjects to more thoroughly massage the liquid into the hair loss area and is expected to improve study protocol compliance.” 

Want to Join a Breezula® Phase 3 Clinical Trial?

If you’re a man with pattern hair loss and are interested in participating in this clinical trial, check out the criteria below to see if you’re eligible to join. Trial eligibility states that you must be (6,7):

• Male
• 18 years old or older
• Diagnosed with mild to moderate androgenetic alopecia affecting the temples and vertex of the scalp  
• Diagnosed with a hair loss classified as Norwood-Hamilton Grades of IIIv through V
• Willing to maintain the same hair style, length, and color for the duration of the study
• Willing to maintain the same dietary and supplement pattern and hair care regimen
• Willing to use birth control if sexually active and not surgically sterile
• Willing and able to undergo a 12-lead electrocardiogram (ECG)

The Breezula® clinical trial lists fairly extensive exclusion criteria, as well. You won’t be eligible for this clinical trial if you have (6,7):

• Any skin problems affecting the scalp (such as fungal or bacterial infections, psoriasis, eczema, scarring, or dermatitis)
• Any secondary health issues, like thyroid disease or malabsorption disorders, that can affect or worsen hair loss
• Any hypersensitivity or allergies to tattoo ink
• Been using anabolic steroids
• Experienced severe dietary or weight changes in the last 6 months
• Participated in a previous clascoterone study.
• Received platelet-rich plasma therapy within 6 months of their second visit.
• Received a scalp procedure such as microneedling or laser hair therapy within 6 months of their second visit.
• Received chemotherapy or a similar treatment, such as scalp radiation
• Used topical scalp treatments such as minoxidil, topical finasteride, or topical dutasteride within 12 weeks of their second visit
• Used hair health or hair growth products, such as saw palmetto or Nioxin, within 2 weeks of their second visit
• Used topical steroids or retinoids on the scalp within 4 weeks of their second visit.
• Used injected or oral beta blockers or corticosteroids
• Used any DHT-blocking medications, such as oral finasteride and dutasteride
• Used hair weaves, non-breathable wigs, or hair bonding in the last 6 months
• Used retinoids, isotretinoin, vitamin A (over 10,000 IU per day), or received cyclosporine therapy within 6 months of their second visit

If you’re not eligible to join one of the Breezula® phase 3 trials, consider joining a different clinical trial. For example, you might be eligible for one of Kintor’s upcoming phase 2 trials for GT20029,  an androgen receptor degrader. Kintor will also likely be advancing with additional phase 3 trials for pyrilutamide, another topical androgen receptor blocker, in the near future.  

Where are the Breezula® Phase 3 Clinical Trials?

The Breezula® phase 3 clinical trials are taking place in 60 centers spread across four countries. According to Dr. Alessandro Mazzetti, the Study Director for these clinical trials, about half of the sites will be based in the United States. SCALP1 is recruiting in the United States and Georgia (in Eastern Europe). SCALP2 is recruiting in the United States, Poland, and Germany. (1,6,7)  

How many men will join the Breezula® Phase 3 Studies?

Cosmo Pharmaceuticals has said that 1,500 men will be recruited across both studies. However, the Clinical Trials listings for both studies state that there will be approximately 726 men recruited in each study (a total of 1,452 men). Around 726 men will be recruited from the United States and Georgia, and the remaining 726 men will be recruited from Germany, Poland, and the United States. (1,6,7)

If you live in one of these countries and are interested in participating in this clinical trial, you should act quickly. Although their clinical trials listings currently state that recruitment has not yet begun, on June 29, 2023, Diana Harbort, President of Cosmo Pharmaceuticals’ Dermatology Division, released a statement announcing that their first participant had been recruited into the Breezula phase 3 trial. (4) Dr. Alessandro Mazzetti confirmed this, saying that the first subjects had been screened in June and that the American sites are now in the process of opening. The European sites, which must undergo a longer approval process, will open at a later date.