FMX101 4% topical minocycline foam was proven to be safe and effective for the treatment of moderate to severe acne in a randomized (1:1), double-blind, a vehicle-controlled study published in the Journal of the American Academy of Dermatology.
Acne is a common skin condition involving blockage and/or inflammation of hair follicles and their glands, which can present as non-inflammatory lesions, inflammatory lesions, or a mixture of both, affecting the face, back and chest. According to the Global Burden of Disease study, acne vulgaris affects 85 percent of young adults aged 12–25 years around the world.
Oral minocycline and doxycycline (tetracyclines) are considered first-line therapy for the treatment of moderate-to-severe acne. The use of topical antibiotics such as clindamycin and erythromycin has been limited due to increasing reports of resistance to these agents.
Tetracyclines can be used as an alternative of topical antibiotics for acne treatment as tetracyclines, particularly minocycline has the lowest rate of resistance. Minocycline is a semisynthetic, second-generation tetracycline, that has demonstrated effectiveness in treating moderate-to-severe acne. However, there are serious concerns about the side effects associated with absorption. Currently, no topical minocycline is available.
FMX101 4% is a novel, topical, foam formulation of minocycline developed for the treatment of moderate-to-severe acne. The formulation is intended to reduce the side effects associated with the use of its oral form. FMX101 4% has been demonstrated as an effective and safe treatment for acne.
Tooraj Joseph Raoof, Encino Research Center, Encino, California, and colleagues conducted this Phase 3 study to further evaluate the efficacy and safety of FMX101 4% in treating moderate-to-severe acne in a larger patient population.
For the purpose, the researchers included a total of 1488 subjects (aged 9 years and above) in the intent-to-treat population. They were randomized 1;1 to receive either FMX101 4% minocycline foam (n=738) or foam vehicle (n=750). Treatment was self-applied once daily for 12 weeks at approximately the same time of day. Efficacy and safety assessments were carried out at 3, 6, 9, and 12 weeks.
The co-primary efficacy endpoints, assessed at week 12, were the absolute change in the inflammatory lesion count from baseline and the rate of IGA treatment success, defined as an IGA score of 0 (clear) or 1 (almost clear), together with an improvement of at least 2 grades in IGA score from baseline.
Co-primary endpoints were the absolute change in inflammatory lesion count from baseline and the rate of treatment success (IGA score: 0 or 1 with a ≥2-grade improvement).
Key findings of the study include:
- 1484 subjects received at least one dose of study drug and 1293 (86.9%) subjects completed the study (FMX101 4%, n=649; vehicle foam, n=644).
- There were no significant differences in baseline demographics and disease characteristics between the FMX101 4% treatment group and the foam vehicle group.
- FMX101 4% was significantly superior to vehicle for both co-primary endpoints in the study. For the first co-primary endpoint, a statistically significant reduction in inflammatory lesions from baseline at week 12 was observed in the FMX101 4% treatment group compared with vehicle (–16.93 vs – 13.40, respectively).
- FMX101 4% minocycline foam appeared to be safe and well tolerated. A total of 255 treatment-emergent AEs (TEAEs) were reported in 193 (26.2%) subjects in the FMX101 4% treatment group, and 235 TEAEs were reported in 183 (24.5%) subjects in the foam vehicle group.
“The results of this large Phase 3 study showed FMX101 4%, the first topical minocycline in a foam formulation, to be a safe and effective treatment option for patients with moderate-to-severe acne. Together with the results of e 2 previous Phase 3 studies, these results provide a strong evidential foundation for the use of FMX101 4% as a topical treatment option for acne,” concluded the authors.
For a detailed study log on to https://doi.org/10.1016/j.jaad.2019.05.078