How CB-03-01 (Clascoterone) Works, Results, Usage, and Side Effects

CB-03-01 (Clascoterone) represents a new paradigm in addressing androgenetic alopecia (AGA). This article delves deep into its scientific mechanism, evaluates the existing clinical evidence, and discusses its emerging role in the battle against hair loss.

Close up showing before and after results of using cb-03-01 (Clascoterone) to treat hair loss

What is CB-03-01?

CB-03-01, also known as Clascoterone, is a promising compound in the field of hair loss treatment. It’s an anti-androgen, which means it works to counteract the effects of androgens, such as dihydrotestosterone (DHT), on hair follicles. DHT is known to contribute to the miniaturization of hair follicles in conditions like androgenic alopecia (male pattern baldness). CB-03-01 does this by blocking the androgen receptors in the hair follicles, thereby preventing the binding of DHT and its detrimental effects. While it may not be as widely recognized as some other hair loss treatments, CB-03-01’s mechanism of action holds promise for those seeking to combat hair thinning and promote regrowth, offering a potential addition to the arsenal of hair loss solutions.

History of CB-03-01

CB-03-01 (Clascoterone) emerged as a significant compound in the field of dermatology and hair loss treatment. Initially discovered for its anti-androgenic properties, it was primarily explored for its potential in acne treatment. Excess androgens play a crucial role in the development of acne, and Clascoterone was developed as a topical cream to address this issue. It functions by blocking androgen receptors in the skin, effectively reducing androgen-related sebaceous gland activity and inflammation associated with acne.

However, Clascoterone’s journey didn’t stop at acne treatment. Researchers recognized its potential in addressing androgenetic alopecia, commonly known as male and female pattern hair loss. The mechanism of action, which involves inhibiting androgens, particularly dihydrotestosterone (DHT), became relevant to hair loss treatment. This led to a shift in focus towards exploring its efficacy in promoting hair growth.

Clinical trials and studies were conducted to assess Clascoterone’s effectiveness and safety in the context of hair loss. These trials aimed to determine whether it could help individuals experiencing hair thinning and pattern baldness. While promising results were obtained, the full extent of its potential for hair restoration and long-term effects continues to be a subject of ongoing research.

In August 2020, Clascoterone received its first official approval from the U.S. Food and Drug Administration (FDA) as a topical solution, marketed under the brand name Winlevi, for the treatment of acne. This marked a significant milestone in its journey from an anti-androgenic compound to a recognized treatment option. Clascoterone’s history exemplifies its evolution from its initial discovery to a promising contender in the realm of both acne and hair loss treatments, with ongoing investigations into its efficacy and safety in these domains.

The Role of DHT in Androgenetic Alopecia

Dihydrotestosterone (DHT) is a hormone derived from testosterone, and it plays a significant role in hair loss, particularly in androgenetic alopecia (male and female pattern baldness). In individuals with a genetic predisposition to hair loss, hair follicles in certain areas of the scalp are sensitive to DHT. When DHT binds to receptors in these follicles, it can lead to a process known as miniaturization. This process causes the hair follicles to shrink over time, resulting in thinner and shorter hair growth cycles. Eventually, the affected follicles may stop producing hair altogether, leading to baldness in those areas. Therefore, DHT is a key factor in the development and progression of hair loss, and treatments often target its effects to mitigate or reverse the condition.

How CB-03-01 Treats Hair Loss

CB-03-01 is a topical anti-androgen that is being investigated for its potential in treating hair loss, particularly androgenetic alopecia (male and female pattern baldness). Its mechanism of action revolves around its ability to block androgens, particularly dihydrotestosterone (DHT), at the hair follicle level. Here’s how CB-03-01 works in the context of hair loss treatment:

  • Androgen Receptor Antagonism: CB-03-01 operates as a potent and selective androgen receptor antagonist. In the context of hair loss, particularly androgenetic alopecia, dihydrotestosterone (DHT) is a key culprit. DHT binds to androgen receptors in hair follicles, initiating a cascade of events that lead to follicular miniaturization. This process involves the gradual shrinking of hair follicles, resulting in thinner, shorter, and less pigmented hair strands. CB-03-01’s primary mode of action involves blocking these androgen receptors, effectively competing with DHT for binding. By doing so, CB-03-01 prevents DHT from attaching to the receptors, interrupting the signaling pathways responsible for hair follicle miniaturization.
  • Halt in Follicular Miniaturization: The inhibition of DHT binding is pivotal for halting or slowing down the process of follicular miniaturization. In essence, CB-03-01 aims to arrest the progression of hair loss by preserving the size and function of existing hair follicles. This preservation of follicular integrity can lead to the production of thicker, healthier hair strands and may promote the retention of existing hair, combating the visual effects of hair thinning and balding.

Empirical Evidence

The compelling molecular mechanism of CB-03-01 finds resonance in clinical evaluations:

  • Phase II Trials: Initial studies demonstrated the drug’s ability to increase hair count and hair density, coupled with its excellent safety profile.
  • Phase III Evaluations: Larger trials further validated its efficacy, wherein participants witnessed significant improvements in global photographic assessments and increased hair growth over placebo.
Chart showing the clinical trial results of CB-03-01 (Clascoterone) to treat hair loss and balding

Trials showing an increase in hair after six months of use with CB-03-01 when compared to minoxidil.


The effectiveness of CB-03-01 for hair loss can vary from person to person, and more extensive research is needed to establish its long-term benefits and side effects definitively. Here’s an overview of the observed results and considerations:

  • Halting Hair Loss: CB-03-01’s primary mechanism of action involves blocking androgen receptors in hair follicles, specifically targeting dihydrotestosterone (DHT). By inhibiting DHT’s binding to these receptors, CB-03-01 aims to halt or slow down the process of follicular miniaturization. This has the potential to prevent further hair loss in individuals with androgenetic alopecia (male and female pattern hair loss).
  • Potential for Hair Regrowth: While CB-03-01’s primary goal is to prevent hair loss progression, some clinical studies have suggested that it may also promote hair regrowth. This could lead to thicker, healthier hair in areas where hair had previously thinned or receded. However, the extent of regrowth can vary among individuals.
Close up showing before and after results of using cb-03-01 (Clascoterone) to treat hair loss

Before and after results of using CB-03-01 to treat hair loss. 

How to Use CB-03-01

The use of CB-03-01 (Clascoterone) for hair loss typically involves the application of a topical solution directly to the scalp. Here’s a general guideline on how to use CB-03-01 for hair loss:

  • Clean Scalp: Start with a clean and dry scalp. You can wash your hair with a mild shampoo and ensure that the scalp is free from excess oil, dirt, and debris.
  • Measure the Dose: Follow the dosing instructions provided by the manufacturer or supplier. Typically, a small amount of CB-03-01 solution is applied to the scalp.
  • Apply to Affected Areas: Use a dropper or applicator to apply the CB-03-01 solution directly to the areas of the scalp where you are experiencing hair loss or thinning. It’s important to target the areas where the hair follicles are sensitive to DHT.
  • Massage Gently: After applying the solution, use your fingertips to gently massage it into the scalp. This helps distribute the product evenly and stimulates blood flow to the follicles.
  • Allow to Dry: Allow the CB-03-01 solution to dry naturally. Avoid using a hair dryer or heat source to speed up the drying process, as this may reduce effectiveness.
  • Frequency of Use: The frequency of application can vary depending on the product and individual preferences. Some users apply CB-03-01 once a day, while others apply it twice daily. 
  • Be Consistent: Consistency in application is essential for potential effectiveness. It may take several months of regular use to see any noticeable results, and individual responses can vary.
  • Monitor for Side Effects: Keep an eye out for any adverse reactions, such as skin irritation, redness, or itching. If you experience any significant or persistent side effects, discontinue use and consult a healthcare professional.


The proper storage of CB-03-01 (Clascoterone) is essential to maintain its stability and effectiveness. Here are some guidelines on how to store CB-03-01:

  • Check the Product Label: Always refer to the product label or packaging for specific storage instructions provided by the manufacturer. Different formulations and brands may have variations in storage requirements.
  • Store in a Cool, Dry Place: In general, CB-03-01 should be stored in a cool, dry place at room temperature. Avoid exposure to excessive heat, humidity, and direct sunlight, as these conditions can potentially affect the stability of the product.
  • Keep the Container Closed: Ensure that the container or bottle is tightly closed when not in use. This helps prevent contamination and preserves the quality of the solution.
  • Protect from Light: Some topical medications, including CB-03-01, may be sensitive to light. If the product is in a clear or translucent container, consider storing it in a dark or opaque container or keeping it in a dark drawer or cupboard.
  • Avoid Freezing: Do not freeze CB-03-01. Extreme cold temperatures can alter the composition of the solution and may render it ineffective.
  • Keep Out of Reach of Children: Store CB-03-01 in a location where it is inaccessible to children and pets. This is important for safety reasons.
  • Check Expiry Date: Always check the expiration date on the product packaging. Do not use CB-03-01 if it has expired, as its efficacy and safety may no longer be guaranteed.
  • Do Not Transfer to Another Container: It’s generally advisable to keep CB-03-01 in its original container, as these containers are typically designed to preserve the stability of the solution. Transferring the product to a different container may expose it to air or contaminants.

Safety and Side Effects

CB-03-01 is a topical medication used for various dermatological conditions, including acne and, potentially, hair loss. Here are the known side effects associated with CB-03-01:

  • Local Skin Irritation: The most common side effect reported with CB-03-01 is mild to moderate skin irritation at the application site. This can include symptoms such as redness, itching, burning, or dryness. These side effects are typically temporary and tend to subside as the skin adapts to the medication.
  • Allergic Reactions: Although rare, some individuals may experience allergic reactions to CB-03-01. Symptoms can include severe itching, hives, swelling, or difficulty breathing. If you notice any signs of an allergic reaction, discontinue use immediately and seek medical attention.
  • Eye Irritation: Care should be taken to avoid contact with the eyes when applying CB-03-01. If the medication comes into contact with the eyes, it can cause eye irritation, redness, or discomfort.
  • Dryness and Peeling: Some users may experience dryness and peeling of the skin at the application site. This can be managed with moisturizers or by adjusting the frequency of application as directed by a healthcare professional.
  • Systemic Absorption: While CB-03-01 is topically applied, there is the potential for a minimal amount of the medication to be absorbed systemically, although this is typically low. It’s advisable for individuals with known systemic health conditions or those taking other medications to consult with their healthcare provider before using CB-03-01.
  • Hair Changes: For individuals using CB-03-01 for hair loss, changes in hair texture or color have been reported in some cases. This may involve hair becoming softer or lighter in color. The significance of these changes can vary.


In the labyrinth of AGA research, CB-03-01 (Clascoterone) shines as a molecule with profound implications. Its unique mode of action, validated by clinical trials, positions it as a potentially transformative agent in the fight against hair loss. As research continues, it could very well redefine AGA treatment paradigms.


  • Caserini, M., et al. (2020). A novel topical antiandrogenic solution for androgenic alopecia treatment. Skin Appendage Disorders, 6(6), 296-304.
  • Dhurat, R., et al. (2019). An open-label randomized multicenter study assessing the noninferiority of a caffeine-based topical liquid 0.2% versus minoxidil 5% solution in male androgenetic alopecia. Skin Appendage Disorders, 5(4), 215-224.
  • Rossi, A., et al. (2011). Minoxidil use in dermatology, side effects and recent patents. Recent Patents on Inflammation & Allergy Drug Discovery, 5(2), 130-136.

Note: This piece serves as an informative overview. Individual responses may vary, and consultation with a qualified medical professional is indispensable before initiating any therapeutic regimen.

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