A Phase II, Randomized, Double-Blind Clinical Study Evaluating the Safety, Tolerability, and Efficacy of a Topical Minocycline Foam, FMX103, for the Treatment of Facial Papulopustular Rosacea

Mrowietz, Ulrich; Kedem, Tal Hetzroni; Keynan, Rita; Eini, Meir; Tamarkin, Dov; Rom, Dror; Shirvan, Mitchell

doi:10.1007/s40257-017-0339-0

Cited by 25 publications

(35 citation statements)

References 13 publications

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“…Minocycline foam (1·5%, 3% vs. vehicle) was evaluated in a 12‐week study at low risk of bias including 232 participants . Reductions in overall rosacea quality‐of‐life index (RosaQoL) score was 0·4 with minocycline vs. 0·2 with vehicle.…”

Section: Resultsmentioning

confidence: 99%

Interventions for rosacea based on the phenotype approach: an updated systematic review includingGRADEassessments

et al. 2019

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SummaryBackgroundRosacea is a common chronic facial dermatosis. Classification of rosacea has evolved from subtyping to phenotyping.ObjectivesTo update our systematic review on interventions for rosacea.MethodsWe searched CENTRAL, MEDLINE, Embase, LILACS, Science Citation Index and ongoing trials registers (March 2018) for randomized controlled trials. Study selection, data extraction, risk‐of‐bias assessment and analyses were carried out independently by two authors. Grading of Recommendations, Assessment, Development and Evaluations (GRADE) was used to assess certainty of evidence.ResultsWe included 152 studies (46 were new), comprising 20 944 participants. Topical interventions included brimonidine, oxymetazoline, metronidazole, azelaic acid, ivermectin and other topical treatments. Systemic interventions included oral antibiotics, combinations with topical treatments or other systemic treatments. Several studies evaluated laser or light‐based treatment. We present the most current evidence for rosacea management based on a phenotype‐led approach.ConclusionsFor reducing temporarily persistent erythema there was high‐certainty evidence for topical brimonidine and moderate certainty for topical oxymetazoline; for erythema and mainly telangiectasia there was low‐to‐moderate‐certainty evidence for laser and intense pulsed light therapy. For reducing papules/pustules there was high‐certainty evidence for topical azelaic acid and topical ivermectin; moderate‐to‐high‐certainty evidence for doxycycline 40 mg modified release (MR) and isotretinoin; and moderate‐certainty evidence for topical metronidazole, and topical minocycline and oral minocycline being equally effective as doxycycline 40 mg MR. There was low‐certainty evidence for tetracycline and low‐dose minocycline. For ocular rosacea, there was moderate‐certainty evidence that oral omega‐3 fatty acids were effective and low‐certainty evidence for ciclosporin ophthalmic emulsion and doxycycline.

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Section: Resultsmentioning

confidence: 99%

Interventions for rosacea based on the phenotype approach: an updated systematic review includingGRADEassessments

et al. 2019

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“…Such effects from oral antibiotics may be circumvented by the use of topical therapy. 4,6 FMX103 1.5% is a topical minocycline foam developed for the treatment of moderate to severe papulopustular rosacea. This formulation leverages the efficacy of minocycline while potentially reducing the risk of systemic adverse effects.…”

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confidence: 99%

“…This formulation leverages the efficacy of minocycline while potentially reducing the risk of systemic adverse effects. 6 The foam is unique because it allows minocycline to exist as a suspended, micronized active ingredient, improving skin penetration 7 and avoiding a grainy sensation on the skin. 8 The main excipients (soybean oil, coconut oil, light mineral oil, and cyclomethicone 5) were chosen for their compatibility with minocycline and their association with moisturizing effects.…”

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confidence: 99%

“…6 FMX103 1.5% resulted in significant reductions in inflammatory lesions and improvement in scores on the Investigator's Global Assessment (IGA) from baseline. 6 Reported here are the results of a phase 3 program consisting of 2 identical, double-blind studies conducted to further assess the efficacy, safety, and tolerability of FMX103 1.5% versus foam vehicle for the treatment of moderate to severe papulopustular rosacea.…”

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confidence: 99%

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Minocycline 1.5% foam for the topical treatment of moderate to severe papulopustular rosacea: Results of 2 phase 3, randomized, clinical trials

Gold

Rosso²,

Kircik

et al. 2020

Journal of the American Academy of Dermatology

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Background: Efficacious topical medications for rosacea are needed. FMX103 1.5% is a novel topical minocycline foam that may have therapeutic benefits in treating rosacea while minimizing systemic adverse effects due to its topical route of delivery. Objective: To determine the efficacy, safety, and tolerability of 12 weeks of treatment with FMX103 1.5% topical minocycline foam for papulopustular rosacea. Methods: Two 12-week, phase 3, randomized, multicenter, double-blind, vehicle-controlled, 2-arm studies were performed in patients with moderate to severe papulopustular rosacea. Results: Participants who received FMX103 1.5%, versus control individuals treated with vehicle, exhibited a significantly greater reduction in the number of inflammatory lesions (FX2016-11:-17.57 vs-15.65; P = .0031; FX2016-12:-18.54 vs-14.88; P \ .0001) and higher rates of Investigator Global Assessment treatment success (FX2016-11: 52.1% vs 43.0%; P = .0273; FX2016-12: 49.1% vs 39.0%; P = .0077). No serious treatment-related treatment-emergent adverse events occurred. Limitations: The generalizability of these data from a controlled clinical trial should be examined in a real-world setting. Conclusions: FMX103 1.5% was efficacious for moderate to severe papulopustular rosacea and maintained a favorable safety profile.

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“…No serious treatment-related AEs were reported. 37 A phase 3 study and a long-term safety study of the 1.5% formulation are underway. 38,39 Two topical minocycline gels are in phase 2 or phase 1/2 studies in patients with moderate to severe papulopustular rosacea.…”

Section: Discussionmentioning

confidence: 99%

Introduction

Gold¹

2018

Sem Cutan Med Surg

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Participants should read the activity information, review the activity in its entirety, and complete the online post-test and evaluation. Upon completing this activity as designed and achieving a passing score on the post-test, you will be directed to a Web page that will allow you to receive your certificate of credit via e-mail or you may print it out at that time. The online post-test and evaluation can be accessed at https://tinyurl.com/acnerosaceasupp2018. Inquiries about CME accreditation may be directed to the

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A Phase II, Randomized, Double-Blind Clinical Study Evaluating the Safety, Tolerability, and Efficacy of a Topical Minocycline Foam, FMX103, for the Treatment of Facial Papulopustular Rosacea

Abstract: NCT02601963.

Cited by 25 publications

References 13 publications

Interventions for rosacea based on the phenotype approach: an updated systematic review includingGRADEassessments

Interventions for rosacea based on the phenotype approach: an updated systematic review includingGRADEassessments

Minocycline 1.5% foam for the topical treatment of moderate to severe papulopustular rosacea: Results of 2 phase 3, randomized, clinical trials

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