Amzeeq (minocycline topical foam 4%) / Fortress - LARVOL DELTA

Prospective, open label, multicenter, single arm, Phase IV study for evaluation of safety, tolerability and efficacy of minocycline hydrochloride topical gel 4% in Indian patients with moderate to severe acne vulgaris. (EADV 2024) - "Introduction & Objectives: Oral antibiotics are considered first-line therapy for the treatment of moderate-to-severe (M2S) acne.1 Though topical antibiotic; clindamycin and erythromycin, are available, their use has been limited by increasing reports of resistance.2 In comparison, tetracyclines are less susceptible to resistance, and, of the tetracycline class, minocycline, in particular, has the lowest rate of resistance.3,4 Minocycline is a semisynthetic, second generation tetracycline with proven anti-inflammatory and bacteriostatic properties.5,6 However, it is associated with significant systemic adverse events.1 Topical minocycline 4% gel is developed to circumvent the systemic side effects associated with the oral formulation and is intended to use in the treatment of M2S acne vulgaris.5 The objective of this study was to evaluate safety, tolerability and efficacy of minocycline hydrochloride topical gel 4% in Indian patients with moderate to severe acne..."

Clinical • P4 data • Acne Vulgaris • Dermatology • Pruritus

Efficacy and safety of topical minocycline foam (FMX101 4%) in treatment of Chinese subjects with moderate-to-severe facial acne vulgaris: A phase 3, multi-centre, randomized, double-blind, vehicle-controlled study. (PubMed, J Eur Acad Dermatol Venereol) - "FMX101 4% treatment for 12 weeks could lead to significantly reduced ILC and nILC, and improved IGA treatment success rate in Chinese subjects with moderate-to-severe facial AV. It also showed a well acceptable safe and tolerability profile."

Clinical • Journal • P3 data • Acne Vulgaris • Dermatology • Inflammation

Drugs for acne. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Acne Vulgaris

CU-10201-301: To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris (clinicaltrials.gov) - P3 | N=372 | Completed | Sponsor: Cutia Therapeutics (Shanghai) Co., Ltd | Active, not recruiting ➔ Completed | Trial completion date: Oct 2023 ➔ Oct 2022

Trial completion • Trial completion date • Acne Vulgaris • Dermatology

A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris (clinicaltrials.gov) - P4 | N=31 | Completed | Sponsor: Edward Lain, MD | Active, not recruiting ➔ Completed | Trial completion date: Nov 2023 ➔ Apr 2023

Trial completion • Trial completion date • Acne Vulgaris • Dermatology

CU-10201-301: To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris (clinicaltrials.gov) - P3 | N=372 | Active, not recruiting | Sponsor: Cutia Therapeutics (Shanghai) Co., Ltd | Trial completion date: Oct 2022 ➔ Oct 2023 | Trial primary completion date: Sep 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Acne Vulgaris • Dermatology

CU-10201-301: To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris (clinicaltrials.gov) - P3 | N=372 | Active, not recruiting | Sponsor: Cutia Therapeutics (Shanghai) Co., Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Acne Vulgaris • Dermatology

A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris (clinicaltrials.gov) - P4 | N=30 | Active, not recruiting | Sponsor: Edward Lain, MD | Recruiting ➔ Active, not recruiting | Trial completion date: Nov 2022 ➔ Nov 2023 | Trial primary completion date: Feb 2022 ➔ Feb 2023

Enrollment closed • Trial completion date • Trial primary completion date • Acne Vulgaris • Dermatology

A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: Edward Lain, MD | Trial primary completion date: Sep 2021 ➔ Feb 2022

Trial primary completion date • Acne Vulgaris • Dermatology

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

Clascoterone cream (Winlevi) for acne. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Acne Vulgaris

CU-10201-301: To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris (clinicaltrials.gov) - P3; N=372; Recruiting; Sponsor: Cutia Therapeutics (Shanghai) Co., Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Acne Vulgaris • Dermatology

To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris (clinicaltrials.gov) - P3; N=372; Not yet recruiting; Sponsor: Cutia Therapeutics (Shanghai) Co., Ltd

Clinical • New P3 trial • Acne Vulgaris • Dermatology

A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris (clinicaltrials.gov) - P4; N=30; Recruiting; Sponsor: Edward Lain, MD; Not yet recruiting ➔ Recruiting

Enrollment open • Acne Vulgaris • Dermatology

A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris (clinicaltrials.gov) - P4; N=30; Not yet recruiting; Sponsor: Edward Lain, MD

Clinical • New P4 trial • Acne Vulgaris • Dermatology

"$VYNE VYNE Therapeutics Announces FDA Approval of AMZEEQ® (Minocycline) Label Update https://t.co/Ovib2d49iQ #fdaapproval" (@stock_titan)

FDA event

Drugs for acne. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Acne Vulgaris • Infectious Disease • Novel Coronavirus Disease

Topical Antisepsis in Head and Neck Cancer Surgery (clinicaltrials.gov) - P; N=25; Recruiting; Sponsor: Medical College of Wisconsin

Clinical • New trial • Head and Neck Cancer • Oncology • Otorhinolaryngology • Solid Tumor

Amzeeq (minocycline foam 4%) for topical treatment of acne vulgaris. (PubMed, Skinmed) - No abstract available

Journal • Acne Vulgaris • Dermatology

[VIRTUAL] Therapeutic Update (FCPANP 2020) - "Goldenberg highlighted the advances in vehicles that have made new formulations possible, including topical tretinoin lotion, topical tazarotene foam, topical 4% minocycline foam, a new first-in-class topical androgen receptor inhibitor Clascoterone (approved for patients 12 years old and up), as well as new data that combination adapalene 0.3% and benozyl peroxide 2.5% gel can reduce the risk of atrophic scar formation within 24 weeks. Oral medications, including a more selective tetracycline, sarecycline, and low-dose micronized isotretinoin, have also shown efficacy while reducing the adverse effects and concerns of their predecessors (e.g. antibiotic resistance and need for concurrent high-fat/high-calorie meals respectively)...This is made possible by advancements such as oxymetazoline cream 1.0% for people with more erythema and telangiectasias, or the use of minocycline 1.5% topical foam, azelaic acid 15% topical foam, ivermectin 1% topical cream and improved..."

Acne Vulgaris • Atopic Dermatitis • Dermatitis • Dermatology • Diabetes • Genetic Disorders • Immunology • Metabolic Disorders • Pruritus • Psoriasis • Rosacea • Skin Cancer • IL13 • JAK3 • TNFA • TYK2

[VIRTUAL] Integrated Efficacy of FMX101 4% Topical Minocycline Foam for the Treatment of Moderate-to-Severe Acne Vulgaris: Analyses of Efficacy in Clinically Relevant Subgroups of Patients (FCDC 2020) - "Abstract not available."

Clinical • Acne Vulgaris • Dermatology

Efficacy and Safety of a Novel Topical Minocycline Foam for the Treatment of Moderate-to-Severe Acne Vulgaris: A Phase 3 Study. (PubMed, J Am Acad Dermatol) - "FMX101 4% topical minocycline foam was effective and safe for the treatment of moderate to severe AV."

Clinical • Journal • P3 data • Acne Vulgaris • Dermatology

Formulation and Profile of FMX101 4% Minocycline Topical Foam for the Treatment of Acne Vulgaris. (PubMed, J Clin Aesthet Dermatol) - "FMX101 4% appeared to be safe, effective, and well tolerated for the treatment of non-nodular inflammatory lesions in moderate-to-severe acne vulgaris. In conclusion, the topical formulation of minocycline in FMX101 4% represents a unique treatment for acne vulgaris and a viable alternative to oral administration."

Journal • Acne Vulgaris • Dermatology

VYNE Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update (GlobeNewswire) - "VYNE Therapeutics Inc...today announced financial results for the third quarter ended September 30, 2020 and provided a corporate update...AMZEEQ (minocycline) topical foam, 4% for the treatment of inflammatory lesions of moderate to severe acne vulgaris in adults and patients 9 years of age and older continues to gain market share in acne. Prescription volume in Q3 2020 was 32,734, representing 52% growth from Q2 2020....End of Phase 2 meeting scheduled in Q4 for FCD105."

Commercial • FDA event • Acne Vulgaris • Dermatology

Minocycline foam (Amzeeq) for acne. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Acne Vulgaris