Clascoterone linked to mild, reversible HPA axis suppression in patients with acne
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Key takeaways:
- Five of the 69 clascoterone-treated patients had abnormal cosyntropin stimulation test (CST) results.
- No relationship existed between the abnormal CST results and clascoterone plasma concentrations.
Clascoterone cream 1% caused mild, reversible hypothalamic-pituitary-adrenal axis suppression under maximum-use exposure in patients with acne vulgaris, according to a study.
“The FDA looked at the data with great care and did not feel that there was any clinical evidence or laboratory suggestion that as practitioners we need to be concerned about hypothalamic-pituitary-adrenal (HPA) axis as we prescribe clascoterone to patients with acne,” Adelaide A. Hebert, MD, chief of pediatric dermatology at McGovern School of Medicine and Children’s Memorial Hermann Hospital, told Healio. “So, why were we required to test for possible HPA axis suppression in the first place?”
According to Hebert, this has to do with the organic structure of clascoterone, which looks a lot like a steroid molecule and requires practitioners to be extra cautious.
“There is really no need for concern or for testing as you use this medication,” Hebert said. “However, the package insert does mention that if you use this in younger children, they may be more susceptible to HPA axis suppression.”
Hebert and colleagues conducted two open-label, multicenter, phase 2 trials evaluating HPA axis suppression in patients with moderate to severe acne vulgaris.
The first study was comprised of 20 adults aged 18 years and older as well as 22 adolescents aged 12 to younger than 18 years, whereas the second study included 27 adolescents aged 9 to younger than 12 years. In both studies, patients applied clascoterone cream 1% twice daily at maximum-exposure dosages for 14 days.
Based on a cosyntropin stimulation test (CST) and blood tests, results showed that five of the 69 total clascoterone-treated patients had abnormal CST results on day 14. This included one adult and two adolescents in the first study and two adolescents in second study. However, the researchers did not find a relationship between the abnormal CST results and clascoterone plasma concentrations.
At the 4-week follow-up, all patients had normal cortisol levels and no clinically relevant adverse events were observed.
“It’s important to realize that none of the patients in the trial, whether they had lab evidence of HPA axis suppression or not, had any clinical evidence of the suppression during the clinical trial,” Hebert said. “Additionally, as the patients were taken off clascoterone and retested, their HPA axis returned to normal.”
While there is evidence of only small amounts of reversible HPA axis suppression, Hebert explains there are many factors that make clascoterone a beneficial treatment option for patients with acne.
“It is very rare where we have a drug, topical or otherwise, where its contraindications as listed on the package insert are stated as none,” Hebert said. “That is a very unique position for medication.”
“The other exciting thing about clascoterone as a medication is this is the first we’ve had an effective and safe option for treating the hormonal aspects of acne in our male populations,” she added. “Because of that, this is really a breakthrough medication.”