Clascoterone Efficacy: What Studies Show After 1 Year

Clascoterone cream 1% is the first FDA-approved topical treatment targeting hormonal acne. Unlike oral medications, it works locally by blocking androgen receptors in the skin, reducing oil production and inflammation without significant systemic side effects. Over a year, studies show consistent improvement in acne severity:

• Facial acne improvement: 19.9% clear/almost clear skin at 12 weeks, increasing to 30.2% after 12 months, and 56.1% for patients completing a full year.
• Truncal acne success: 59.2% after a year for consistent users.
• Lesion reduction: Steady decline in both inflammatory and non-inflammatory lesions over time.

The treatment is safe, with mild side effects like dryness or irritation reported in 18.1% of users. Clascoterone offers an effective option for managing hormonal acne without the risks of oral anti-androgens. Consistency is key for achieving the best results.

Confirmed: Clascoterone Reduces Sebum Production and Improves Acne

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Phase 3 Trial Results

Two Phase 3 trials, CB-03-01/25 and CB-03-01/26, included 1,440 participants aged 9 to 58 years, all dealing with moderate to severe facial acne. The median age of participants was 18, and about 62% were female. Over the 12-week treatment period, patients applied either clascoterone 1% cream or a placebo twice daily. These trials provided critical data on the effectiveness of clascoterone, beginning with its impact on lesion reduction. The results from this short-term study also laid the groundwork for understanding its longer-term benefits over a year.

Lesion Reduction at 12 Weeks

By the end of the 12 weeks, clascoterone showed clear advantages over the placebo. Non-inflammatory lesion counts dropped by an average of 19.4 with clascoterone, compared to reductions of 10.8–13.0 in the placebo group. Inflammatory lesions decreased by 19.3–20.0 with clascoterone, compared to 12.6–15.5 in those using the placebo. Total lesion counts saw a reduction of roughly 39–40 lesions (about 37%) with clascoterone, while the placebo group experienced a decrease of 24–29 lesions.

"Results of 2 phase 3 randomized clinical trials including 1,440 patients demonstrated that patients with acne treated with clascoterone cream, 1%, experienced greater treatment success vs treatment with vehicle, with considerable reductions in absolute noninflammatory and inflammatory lesion counts."

• JAMA Dermatology

In addition to lesion counts, the trials also assessed overall skin clarity using Investigator's Global Assessment (IGA) scores.

Investigator's Global Assessment (IGA) Scores

The primary goal was to measure treatment success, defined as achieving an IGA score of 0 or 1 with at least a two-grade improvement. In Trial 1, 18.4% of patients treated with clascoterone met this benchmark, compared to 9.0% in the placebo group. Trial 2 showed similar results, with 20.3% of clascoterone users achieving success versus 6.5% of those on placebo. A pooled analysis of participants aged 12 and older revealed that 19.9% of patients using clascoterone reached treatment success, compared to just 7.7% in the placebo group.

1-Year Efficacy Data

Building on the Phase 3 trial results, data from longer-term studies highlight clascoterone’s improving efficacy over 12 months. These extension studies indicate that the treatment's benefits steadily increase with continued use, similar to other androgen-driven acne treatment options.

Lesion Count Changes Over 1 Year

In the early stages, clascoterone treatment led to an average reduction of 20.8 non-inflammatory lesions and 19.7 inflammatory lesions. Total lesion counts dropped by 40.0, compared to 26.1 in the placebo group. Over the course of 12 months, lesion counts continued to decline steadily.

"The efficacy of clascoterone cream 1% for the treatment of acne vulgaris increased over time for up to 12 months in all treated patients." - Lawrence F. Eichenfield, MD

This consistent improvement underscores the importance of sticking with the treatment to achieve the best results.

IGA Scores After 1 Year

The Investigator's Global Assessment (IGA) scores further illustrate the long-term benefits. During the Phase 3 trial, 19.9% of patients achieved clear or almost clear skin (IGA 0/1) by week 12. By the end of a full year, this figure rose to 30.2% across all patients. Among those who completed the entire 12-month course, success rates were even higher - 56.1% for facial acne and 59.2% for truncal acne.

Interestingly, skin clarity rates that reached 18.9% at six months nearly tripled by the 12-month mark. Subgroup analyses also showed consistent improvements across different age groups:

• Adolescents (12–17 years): 45.6% achieved treatment success.
• Adults (18+ years): 54.0% reached clear or almost clear skin.
• Adult women (25+ years): 44.4% saw similar outcomes.

Baseline vs. 1-Year Results

The progression from baseline to one year highlights clascoterone’s sustained impact. All patients began with moderate-to-severe acne (IGA scores of 3 or 4). The table below provides a snapshot of the changes over time:

Metric	Baseline	12 Weeks	12 Months
Facial IGA Success (0/1)	0%	19.9%	30.2% to 56.1%*
Truncal IGA Success (0/1)	4.8%–4.9%	13.6%	31.7% to 59.2%*
Non-Inflammatory Lesion Reduction	~60.9 (average count)	-20.8	Continued reduction
Inflammatory Lesion Reduction	~42.6 (average count)	-19.7	Continued reduction

*Higher percentages reflect patients who completed the full 12-month treatment course.

Additionally, patients who initially received a placebo during the trial and later switched to clascoterone showed remarkable progress. Their success rates jumped from 13.5% to 30.4% by the end of the extension period. This demonstrates that even delayed treatment initiation can yield meaningful results over time.

Safety Profile Over 1 Year

Clascoterone cream 1% not only maintains its effectiveness over extended periods but also shows a dependable safety profile during 12 months of continuous use. Its quick conversion to inactive cortexolone significantly reduces systemic exposure, making it a safer alternative to oral hormonal treatments, which often come with broader side effects.

Reported Side Effects

In one-year extension studies, 18.1% of patients experienced at least one treatment-emergent adverse event (TEAE). The majority of these side effects were mild or moderate, with only 1.5% of patients discontinuing treatment due to adverse reactions. Common local skin reactions included scaling or dryness (10.0%) and erythema (8.0%). Non-local side effects, such as nasopharyngitis (2.8%), upper respiratory tract infections (1.8%), and sinusitis (0.8%), were typically unrelated to the medication. Serious adverse events were rare, affecting just 1.0% of patients, and none were linked to the treatment.

"This 9-month extension study confirmed the favorable safety profile of clascoterone cream 1% in the long-term treatment of patients ages 12 and older... Most of the TEAEs were mild, and no accumulation of adverse events was observed over time." - Lawrence Eichenfield, MD

Unlike single medications for hormonal acne like spironolactone, clascoterone does not require routine lab monitoring for systemic parameters such as potassium levels. Mild, asymptomatic suppression of the HPA axis was observed in a few cases but typically resolved within four weeks of stopping treatment.

Patient Tolerability

Patients consistently reported high tolerability of clascoterone cream over the 12-month period. Local reactions such as stinging, burning, or swelling were rare, and the overall safety profile remained steady from the initial 12 weeks through the full year. The low discontinuation rate and the stable occurrence of adverse events suggest that patients who tolerate the cream during the first few months are likely to continue tolerating it well over the long term. This makes clascoterone a reliable option for managing hormonal acne (you can assess your breakouts to determine severity) without the need for the monitoring often required with systemic treatments.

What This Means for Hormonal Acne Treatment

The availability of one-year data on clascoterone marks a major advancement in treating hormonal acne. As the first FDA-approved topical androgen receptor inhibitor, clascoterone offers steady improvements while avoiding the systemic side effects typically associated with oral medications. This is particularly beneficial for individuals with PCOS or other androgen-related conditions, who have historically had limited options for effective treatment. These findings open new doors for managing hormonal acne with more targeted strategies.

How Clascoterone Fits Into Treatment Plans

Unlike oral anti-androgens like spironolactone or combined oral contraceptives, clascoterone works locally on the skin and is quickly metabolized into an inactive form. This minimizes systemic exposure and reduces the need for extensive monitoring. It’s suitable for both men and women and doesn’t require routine potassium level checks. This makes clascoterone a flexible option, whether used on its own or in combination with other treatments. For patients who cannot or prefer not to take oral hormonal medications - due to side effects, contraindications, or personal preferences - it offers a science-backed alternative.

"Clascoterone presents an exciting opportunity for dermatologists to further optimize care for eligible acne patients, either as a monotherapy or in combination with other anti-acne medications." - Hannah Peterson, BS, Loma Linda University School of Medicine

Consistency is key with clascoterone. Dr. Lawrence F. Eichenfield emphasizes, "Clinicians may consider counseling patients that treatment persistence is required to maximize the efficacy of clascoterone treatment". Long-term use has shown impressive results, with success rates of 44.4% after 12 months in women aged 25 and older.

Access Through Telehealth

Clascoterone’s safety and ease of use make it a natural fit for telehealth-based care. Since it doesn’t require frequent lab monitoring, it’s well-suited for remote management. Platforms like Oana Health offer personalized, prescription-based care for hormonal conditions, including PCOS-related acne. Licensed professionals review patient histories online and design tailored treatment plans that may include clascoterone, alongside other options such as spironolactone or topical spironolactone. Treatments are shipped directly to patients’ homes, eliminating the need for pharmacy visits while ensuring access to FDA-approved medications. This convenient approach supports consistent treatment and better long-term results.

Conclusion

Research highlights clascoterone's potential as an effective option for long-term acne control. Studies show that its benefits extend well beyond the initial 12 weeks of use. After a year of treatment, facial acne improvement was observed in 30.2% of users at 12 months, climbing to 56.1% among those who stayed consistent with the treatment over the same period. Women aged 25 and older, a group often dealing with hormonal acne, experienced a 44.4% success rate after a year of use. Importantly, these results were achieved with a favorable safety profile throughout extended application.

Consistency plays a critical role in achieving results with clascoterone. By targeting androgen receptors in the skin, it gradually reduces sebum production and inflammation without the systemic side effects often associated with oral hormonal treatments. This topical medication is suitable for both men and women, requires no regular lab monitoring, and can be applied to areas beyond the face, such as the chest, shoulders, and back. While the twice-daily application demands commitment, the steady improvements make it a worthwhile part of a skincare routine.

For individuals struggling with persistent hormonal acne, clascoterone stands out as a scientifically supported option to discuss with a healthcare provider. Its targeted, topical approach minimizes systemic exposure while delivering proven long-term results. This combination of effectiveness and safety positions clascoterone as a valuable tool in the contemporary management of hormonal acne.

FAQs

How long does clascoterone take to work?

Clascoterone typically begins to show visible effects after about 12 weeks of regular application, with improvements becoming more noticeable over time. Research suggests that around 30% of users experience success in facial treatment after a year of consistent use. However, individual results can differ based on various factors, and steady progress is often observed with prolonged use.

Can I use clascoterone with retinoids or benzoyl peroxide?

Clascoterone cream 1% has been shown to be both effective and safe when used on its own for treating acne. While specific studies on combining it with retinoids or benzoyl peroxide are lacking, research indicates that clascoterone remains stable when paired with these topical treatments. This suggests that combination therapy could be a possibility. However, it's essential to consult your healthcare provider before starting or mixing treatments to ensure safety and effectiveness.

Who is clascoterone best for (including PCOS or adult hormonal acne)?

Clascoterone works best for people aged 12 and older who struggle with hormonal acne. This includes both teenagers and adults dealing with hormonal breakouts, as well as those with moderate-to-severe acne. Clinical trials have confirmed its safety and effectiveness for this group.