Zilxi (minocycline topical foam 1.5%) / Fortress - LARVOL DELTA

Efficacy and safety of topical minocycline preparations for papulopustular rosacea: a systematic review and meta-analysis. (PubMed, Front Med (Lausanne)) - "Minocycline (FMX103) 1.5% foam yielded statistically significant results in terms of IGA score indicating treatment success [Risk Ratio (RR) = 1.31, 95% confidence interval (CI) = 1.04-1.66, P = 0.02]. Further studies, however, should assess the efficacy of different concentrations and combinations of minocycline to better delineate the effect of this drug in the clinical aspect. PROSPERO, identifier CRD42023447486, https://www.crd.york.ac.uk/PROSPERO/view/CRD42023447486."

Clinical • Journal • Retrospective data • Review • Dermatology • Rosacea

Topical Antisepsis in Head and Neck Cancer Surgery (clinicaltrials.gov) - P=N/A | N=25 | Completed | Sponsor: Medical College of Wisconsin | Recruiting ➔ Completed | Trial completion date: Feb 2022 ➔ Oct 2021 | Trial primary completion date: Feb 2022 ➔ May 2021

Trial completion • Trial completion date • Trial primary completion date • Head and Neck Cancer • Infectious Disease • Oncology • Otorhinolaryngology • Solid Tumor

Safety and Pharmacokinetics of FMX103 (1.5% Minocycline Topical Foam) in Subjects with Moderate-to-Severe Papulopustular Rosacea under Maximum-use Treatment Conditions. (PubMed, J Clin Aesthet Dermatol) - "Daily application of FMX103 1.5% was generally safe and well-tolerated by all subjects. Once-daily topical application of FMX103 1.5% did not lead to appreciable systemic exposure or accumulation of minocycline, suggesting that it is a viable treatment option for papulopustular rosacea."

Clinical • Journal • PK/PD data • Dermatology • Rosacea

Open-label Extension Study Evaluating Long-term Safety and Efficacy of FMX103 1.5% Minocycline Topical Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea. (PubMed, J Clin Aesthet Dermatol) - " FMX103 1.5% demonstrated a favorable safety and tolerability profile for up to 52 weeks. Long-term efficacy was demonstrated by progressive reductions in inflammatory lesions and increasing IGA treatment success, suggesting that FMX103 1.5% may be a suitable option for the treatment for papulopustular rosacea."

Clinical • Journal • Dermatology • Rosacea

[VIRTUAL] Integrated Safety and Efficacy Analysis of FMX103 1.5% Topical Minocycline Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea: Results From Two Phase 3 Studies (FCPANP 2020) - "Other AE’s were not clinically significant and otherwise similar between treatment and vehicle groups. Overall, despite limitations with population diversity, these two studies demonstrated the efficacy, safety, and tolerability of minocycline 1.5% topical foam for the treatment of moderate to severe papulopustular rosacea."

Clinical • P3 data • Dermatology • Pruritus • Rosacea

[VIRTUAL] Open-Label Extension Study Evaluating the Long-Term Safety, Efficacy, and Tolerability of FMX103 1.5% Topical Minocycline Foam in the Treatment of Moderate-to-Severe Facial Papulopustular Rosacea (FCPANP 2020) - "Abstract Not Available."

Clinical • Dermatology • Rosacea

[VIRTUAL] Open-Label Extension Study Evaluating the Long-Term Safety, Efficacy, and Tolerability of FMX103 1.5% Topical Minocycline Foam in the Treatment of Moderate-to-Severe Facial Papulopustular Rosacea (FCDC 2020) - "Abstract not available."

Clinical • Dermatology • Rosacea

[VIRTUAL] Integrated Safety and Efficacy Analysis of FMX103 1.5% Topical Minocycline Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea: Results From Two Phase 3 Studies (FCDC 2020) - "Abstract not available."

Clinical • P3 data • Dermatology • Rosacea

A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea (clinicaltrials.gov) - P3; N=771; Completed; Sponsor: Foamix Ltd.

Clinical • New P3 trial • Dermatology • Rosacea

A Study (Study 1) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea (clinicaltrials.gov) - P3; N=751; Completed; Sponsor: Foamix Ltd.; N=1522 ➔ 751

Clinical • Enrollment change • Dermatology • Rosacea