The conversation is about the approval of Clascoterone (Winlevi) in Canada for hair loss treatment. One user expressed skepticism about its effectiveness due to low concentration.
A Phase 1 update for the HMI 115 clinical trial, which involves 16 participants and is expected to end in July 2023; as well as changes to the recruitment process, including treatment protocols with Minoxidil, Finasteride, and RU58841.
The user received hormone test results showing normal estradiol and testosterone levels, low SHBG, and normal free androgen index. They are considering starting finasteride but are concerned due to being slightly overweight.
The acne medication Winlevi, which contains Clascoterone, is available in the U.S. and may slow down hair loss until a higher concentration treatment, Breezula, is released.
The FDA policy change may speed up approval for hair loss drugs like PP405, VDPHL-01, and Breezula by potentially eliminating the need for a second confirmatory Phase 3 trial. Approval timelines could be as early as 2028 for some treatments if Phase 3 results are strong.
Clascoterone's European release is expected in Q4 2026, with FDA approval anticipated by mid-2027. The discussion includes questions about the approval timeline and potential acceleration due to unmet needs.
The conversation discusses the safety study of PP405, emphasizing that early trials focus on safety rather than efficacy, and that any efficacy data from such a short study should be viewed skeptically. It also highlights that the information released is primarily for securing funding, and that meaningful efficacy results are expected in later phases.
A user in the UAE is facing customs issues with ordering Fluridil (Eucapil) and is considering ordering smaller quantities or switching to Pyrilutamide. They are also using finasteride daily to maintain hair and are unsure of Fluridil's effectiveness.
PP405's phase 2a trial results were presented, focusing on safety and pharmacokinetics, with a future meeting planned to share the full dataset. The trial includes a randomized controlled portion and an open-label extension, with no indication of phase 2B completion.
Clascoterone cream was submitted for review to Health Canada in August 2022, with hopes of approval within 3-6 months. It may potentially enhance finasteride's effects for hair loss treatment.
Pyrilutamide shows minimal systemic absorption with low plasma levels and no accumulation, suggesting it's unlikely to cause systemic side effects. However, full results are not yet published in scientific journals.
Topical finasteride is considered safer for the liver than oral finasteride due to less systemic absorption, but regular liver function tests are advised. The user is concerned about liver health due to a history of NAFLD and is exploring topical finasteride as a safer alternative.
Pirfenidone is suggested to treat fibrosis and baldness by blocking inflammation markers and reducing collagen. It is also available as a gel for scar removal.
Dutasteride users should get yearly kidney and liver tests, especially young people. General health checkups are not common in the UK, but such tests are recommended as a precaution.
Clascoterone, a topical anti-androgen, is generating interest for potentially fewer systemic side effects. Users are curious about its effectiveness and details like concentration and duration of use.
CRISPR treatments for blood disorders have been approved, leading to discussions about its potential for treating hair loss (AGA). A study showed that editing a gene related to DHT sensitivity could lead to hair regrowth, suggesting CRISPR may eventually be used for AGA, but it's expected to be expensive and not soon available.
Before starting hair loss treatment, it's suggested to undergo various blood and health tests to minimize side effects. The checklist includes tests for kidney function, liver enzymes, blood sugar, vitamins, hormones, and more.
The user is experiencing diffuse thinning and inflammation despite using 2.5mg dutasteride daily, ciclopirox, and ketoconazole shampoos. They are considering treatments like hydroxychloroquine and JAK inhibitors due to suspected scarring alopecia and have faced challenges in obtaining a scalp biopsy.
A user trying to avoid an expensive hair transplant, and the replies suggesting they wait two years on treatment before deciding if they need a transplant or not.
A 27-year-old male with diffuse hair loss, including the donor area, did not respond to finasteride, dutasteride, or minoxidil. He suspects his hair loss may be linked to a mild connective tissue disorder, possibly affecting the structural support of hair follicles, rather than being purely hormonal.
The conversation discusses a clinical trial for Setipiprant in the US, starting June 29th, with eligibility excluding recent users of minoxidil or finasteride. It encourages informed decision-making before signing up.
Considering a hair transplant, using Pyrilutamide, the potential availability of CosmeRNA, and the significance of taking Minoxidil and Finasteride for long-term results.
Some users of RU-58841 report cardiovascular symptoms like heart palpitations and chest tightness, which may be linked to its metabolites causing lung disease. The safety of RU-58841 is uncertain due to lack of long-term data and concerns about product purity, especially from gray market sources.
The conversation discusses the absorption and effectiveness of PG-free versus PG versions of RU58841, with some users believing PG improves efficacy while others see no difference. Concerns about RU58841's potential side effects on the endocrine system are also mentioned, with one user considering switching to pyrilutamide.
Finasteride and Dutasteride will remain accessible in the EU despite objections from France and Belgium. Users discuss the ease of obtaining these medications in different countries and express relief and support for the EU's decision.
A user with alopecia totalis, borderline universalis, seeks advice on getting into a Xeljanz trial or appealing insurance for coverage. They experienced significant hair regrowth but are now seeing hair loss again and want to try Xeljanz.
The post discusses the user's experience with hair loss treatment RU58841, which was tested for quality and found to be 96+% pure. The conversation includes various responses, with some users questioning the safety of the product and others expressing satisfaction with the test results.
FCE 28260 (PNU 156765), an under-explored 5α-reductase inhibitor, showcases promising results in research by Giudici et al., outperforming well-known treatments like Finasteride in reducing the conversion of testosterone to DHT. Its superior efficacy, demonstrated through lower IC50 values in both natural and human recombinant enzyme studies, suggests it could offer more effective management of DHT-related conditions. Additionally, its lower molecular weight hints at better potential for topical application, potentially offering advantages in treating conditions such as androgenic alopecia. Despite its potential, it has not advanced in development, possibly due to financial limitations, leaving its therapeutic prospects and side effect profile largely unexplored.
The user is experiencing one-sided diffuse thinning and has been using finasteride and liquid minoxidil for 4-5 years with minimal results. They are considering whether to save for a hair transplant or address scalp sensitivity and irritation first.