Clascoterone Cream 1% Deemed Stable When Combined With Other Topical Acne Treatments

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In a recent poster presented at the 2024 Society of Dermatology Physician Associates (SDPA) Fall Conference in Las Vegas, Nevada, investigators developed a method to evaluate the stability of clascoterone cream (Winlevi) when combined with other commonly prescribed topical acne medications such as retinoids, antibiotics, and benzoyl peroxide. Overall, Draelos et al determined that clascoterone cream was “consistently and reproducibly stable in the presence of other topical acne medications.”¹

Clascoterone cream 1% is an androgen receptor inhibitor that was FDA-approved for the treatment of acne vulgaris in patients aged 12 years and older in August 2020.² With numerous available treatment options for patients with acne, the updated American Academy of Dermatology (AAD) acne guidelines recommend the strategy of multimodal topical therapy by incorporating acne products with multiple mechanisms of action to best serve patients.³ According to Draelos et al, dermatology clinicians may use the AAD’s guidelines to combine clascoterone cream with other topical acne treatments. However, there is currently no available data on the stability of clascoterone cream when combined with other topical acne medications.

Methods

To analyze clascoterone cream’s stability with other topicals, tretinoin cream 0.025%, adapalene gel 0.3%, dapsone gel 7.5%, azelaic acid 15%, benzoyl peroxide 5%/clindamycin 1%, benzoyl peroxide 2.5%/adapalene 0.1%, and encapsulated benzoyl peroxide 5% (0.5 mL each) were placed separately on individual microscope slides followed by 0.5 mL of clascoterone cream and incubated for 8 hours at 37 °C.

“Microscope slides were placed in a conical vial with 10 mL of methanol containing an internal calibrant and 10 mL of tetrahydrofuran, and the vial was agitated until all visible material was removed from the slide. The solution was filtered with a 0.2-micron nylon filter and analyzed with high-pressure liquid chromatography-mass spectrometry (HPLC-MS),” wrote Draelos et al.

Regarding LC-MS parameters, high-performance liquid chromatography was performed at a flow rate of 1 mL/min with a binary system consisting of (A) H2 O + 0.1% formic acid and (B) methanol + 0.1% formic acid. The column was pre-equilibrated for 5 minutes with 65% A and 35% B prior to each injection. The standard curve of the test showed that the system was properly calibrated, allowing for sensitive and consistent detection of clascoterone.

Results

The mean percentage of clascoterone cream recovered after layering it with other topical acne medications ranged from 98% for encapsulated benzoyl peroxide to 119% for azelaic acid, suggesting that clascoterone cream was stable among all tested topical acne medications. The mean percentage of clascoterone cream recovered after the injection of clascoterone cream alone was 86%.

“To ensure the consistency of clascoterone recovery and to determine if any conditions changed from the start to the end of the LC-MS run, clascoterone plus tretinoin and clascoterone plus adapalene were reinjected for LCMS assessment of clascoterone recovery 12 hours after the original injections,” wrote Draelos et al.

The mean percentage of clascoterone recovered from the reinjected clascoterone plus tretinoin and clascoterone plus adapalene samples was 101% and 97%, respectively, which was within 8% of that recovered from the initial injections.

“Clascoterone was consistently and reproducibly stable in the presence of other topical acne medications. The combination of clascoterone cream 1% with topical retinoids, topical antibiotics, and/or benzoyl peroxide may be a viable strategy for the treatment of acne vulgaris. This method may be adaptable for testing the stability of other topical acne medications,” concluded Draelos et al.

References

1. Draelos Z, Kyeremateng K, Squittieri N, Draelos M. Clascoterone stability when combined with topical acne medications. Poster presented at: 2024 Society for Dermatology Physician Associates Fall Conference; November 14-17, 2024; Las Vegas, NV
2. Cassiopea receives FDA approval for Winlevi (clascoterone cream 1%), first-in-class topical acne treatment targeting the androgen receptor. News release. PR Newswire. August 27, 2020. Accessed. August 27, 2020. https://www.prnewswire.com/news-releases/cassiopea-receives-fda-approval-for-winlevi-clascoterone-cream-1-first-in-class-topical-acne-treatment-targeting-the-androgen-receptor-301119454.html
3. Reynolds RV, Yeung H, Cheng CE, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024;90(5):1006.e1-1006.e30. doi:10.1016/j.jaad.2023.12.017