were assessed in 2 identical Phase 3 clinical trials and a long-term extension study in patients greater than or equal to 9 years of age with moderate-to-severe acne vulgaris.1,7 In the Phase 3 pivotal studies, treatment with clascoterone cream 1% resulted in significant clinical improvement compared with vehicle cream after 12 weeks of twice-daily application, with a favorable safety profile.1 Clascoterone safety was well maintained for up to an additional 9 months of treatment in patients greater than or equal to 9 years old with moderate-to-severe acne vulgaris.7 Here, we present long-term safety and efficacy data in the subgroup of clinical trial patients greater than or equal to 12 years old who entered the long-term extension study.
MATERIALS AND METHODS
Study Design and Patients
The multicenter, open-label, long-term safety study of clascoterone cream 1% in patients with moderate-to-severe acne vulgaris greater than or equal to 9 years of age (www.clinicaltrials.gov NCT 02682264) was previously described in detail.7 The original study was conducted in accordance with principles of the Declaration of Helsinki, the current Good Clinical Practice guidelines, and all country-specific regulatory requirements. Institutional Review Board approval was obtained for the protocol and informed consent forms. Voluntary informed consent was given by every patient, and patients under the age of 18 years provided written informed consent and were accompanied by a parent or legal guardian; the parent or legal guardian also provided informed consent for the patient.
Patients completed one of the Phase 3 pivotal studies and enrolled within 3 days of the final pivotal study visit to be eligible for the extension study.7 This analysis only included patients greater than or equal to 12 years of age.
Patients completed one of the Phase 3 pivotal studies and enrolled within 3 days of the final pivotal study visit to be eligible for the extension study.7 This analysis only included patients greater than or equal to 12 years of age.
Treatments Administered
All patients applied clascoterone cream 1% twice daily to the entire face and, if desired by both patient and investigator, truncal acne for up to 9 additional months of treatment. Patients randomized to vehicle cream in the pivotal studies applied clascoterone cream in the long-term extension; patients originally randomized to clascoterone cream continued treatment. The maximum clascoterone treatment time in the pivotal and extension studies was 12 months for the face (3 months in the pivotal studies and 9 months in the extension study) and 9 months for the trunk. Patients who achieved Investigator's Global Assessment (IGA) score of 0 or 1 (IGA 0/1) could stop treatment and resume if/when acne worsened (Figure 1).
Assessments and Outcomes
Safety and efficacy were assessed at scheduled patient visits at months 1, 3, 6, and 97 (Figure 1). As previously described,7 primary safety endpoints included frequencies of local and systemic treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), and frequency and severity of local skin reactions (LSRs). The investigator evaluated the severity of telangiectasia, skin atrophy, striae rubrae, erythema, edema, and scaling/dryness using a 5-point scale from 0 (none) to 4 (severe); patients were asked to rate the severity of stinging/burning and pruritus using a 4-point scale from 0 (none) to 3 (severe).
