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1 Trial |  |
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- minocycline / Generic mfg.
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. (Poster Area) - Aug 5, 2024 - Abstract #EADV2024EADV_1638;
The safety profile for Indian patients was similar to that seen in landmark clinical studies for minocycline 4% foam. Taken in its entirety minocycline 4% gel provides a strong evidential foundation for a new topical treatment option for patients with M2S acne.
- ||| Amzeeq (minocycline topical foam 4%) / Fortress
Clinical, P3 data, Journal: 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 Central) - Jul 1, 2024
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.
- | Winlevi (clascoterone cream 1%) / Cassiopea
Journal: Drugs for acne. (Pubmed Central) - Jan 31, 2024
It also showed a well acceptable safe and tolerability profile. No abstract available
- ||||||| Amzeeq (minocycline topical foam 4%) / Fortress
Trial completion, Trial completion date: CU-10201-301: To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris (clinicaltrials.gov) - Sep 28, 2023
P3, N=372, Completed, Sponsor: Cutia Therapeutics (Shanghai) Co., Ltd
No abstract available Active, not recruiting --> Completed | Trial completion date: Oct 2023 --> Oct 2022
- Amzeeq (minocycline topical foam 4%) / Fortress
Trial completion, Trial completion date: A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris (clinicaltrials.gov) - Jun 22, 2023
P4, N=31, Completed, Sponsor: Edward Lain, MD
Active, not recruiting --> Completed | Trial completion date: Oct 2023 --> Oct 2022 Active, not recruiting --> Completed | Trial completion date: Nov 2023 --> Apr 2023
- |||| Amzeeq (minocycline topical foam 4%) / Fortress
Trial completion date, Trial primary completion date: CU-10201-301: To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris (clinicaltrials.gov) - Feb 17, 2023
P3, N=372, Active, not recruiting, Sponsor: Cutia Therapeutics (Shanghai) Co., Ltd
Active, not recruiting --> Completed | Trial completion date: Nov 2023 --> Apr 2023 Trial completion date: Oct 2022 --> Oct 2023 | Trial primary completion date: Sep 2022 --> May 2023
- ||||| Amzeeq (minocycline topical foam 4%) / Fortress
Enrollment closed: CU-10201-301: To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris (clinicaltrials.gov) - Jul 14, 2022
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 Recruiting --> Active, not recruiting
- Amzeeq (minocycline topical foam 4%) / Fortress
Enrollment closed, Trial completion date, Trial primary completion date: A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris (clinicaltrials.gov) - Mar 23, 2022
P4, N=30, Active, not recruiting, Sponsor: Edward Lain, MD
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: Feb 2022 --> Feb 2023
- Amzeeq (minocycline topical foam 4%) / Fortress
Trial primary completion date: A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris (clinicaltrials.gov) - Feb 15, 2022
P4, N=30, Recruiting, Sponsor: Edward Lain, MD
Recruiting --> Active, not recruiting | Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: Feb 2022 --> Feb 2023 Trial primary completion date: Sep 2021 --> Feb 2022
- | Winlevi (clascoterone cream 1%) / Cassiopea
Journal: Clascoterone cream (Winlevi) for acne. (Pubmed Central) - Feb 8, 2022
Trial primary completion date: Sep 2021 --> Feb 2022 No abstract available
- | Amzeeq (minocycline topical foam 4%) / Fortress, Zilxi (minocycline topical foam 1.5%) / Fortress
Trial completion, Trial completion date, Trial primary completion date, Surgery: Topical Antisepsis in Head and Neck Cancer Surgery (clinicaltrials.gov) - Feb 6, 2022
P=N/A, N=25, Completed, Sponsor: Medical College of Wisconsin
No abstract available Recruiting --> Completed | Trial completion date: Feb 2022 --> Oct 2021 | Trial primary completion date: Feb 2022 --> May 2021
- |||||| Amzeeq (minocycline topical foam 4%) / Fortress
Enrollment open: CU-10201-301: To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris (clinicaltrials.gov) - Dec 14, 2021
P3, N=372, Recruiting, Sponsor: Cutia Therapeutics (Shanghai) Co., Ltd
Recruiting --> Completed | Trial completion date: Feb 2022 --> Oct 2021 | Trial primary completion date: Feb 2022 --> May 2021 Not yet recruiting --> Recruiting
- | Amzeeq (minocycline topical foam 4%) / Vyne Therap
Journal: Amzeeq (minocycline foam 4%) for topical treatment of acne vulgaris. (Pubmed Central) - Oct 14, 2021
Not yet recruiting --> Recruiting No abstract available
- | Amzeeq (minocycline topical foam 4%) / Fortress
New P3 trial: CU-10201-301: To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris (clinicaltrials.gov) - Jul 13, 2021
P3, N=372, Not yet recruiting, Sponsor: Cutia Therapeutics (Shanghai) Co., Ltd
- Amzeeq (minocycline topical foam 4%) / Fortress
Enrollment open: A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris (clinicaltrials.gov) - Jul 1, 2021
P4, N=30, Recruiting, Sponsor: Edward Lain, MD
No abstract available Not yet recruiting --> Recruiting
- | Amzeeq (minocycline topical foam 4%) / Fortress
New P4 trial: A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris (clinicaltrials.gov) - Jun 28, 2021
P4, N=30, Not yet recruiting, Sponsor: Edward Lain, MD
- || minocycline / Generic mfg.
Review, Journal: Topical Minocycline Foam 4%: A Review in Acne Vulgaris. (Pubmed Central) - Mar 30, 2021
Cutaneous AEs were uncommon, and findings from a dermal safety study showed that topical minocycline foam 4% did not have any effects related to phototoxicity, photoallergy, skin sensitization and skin irritation. Topical minocycline foam 4% is thus a useful addition to available treatment options for the management of inflammatory lesions of non-nodular, moderate to severe acne in adult and pediatric patients aged ≥ 9 years.
- | Amzeeq (minocycline topical foam 4%) / Menlo Therap, FM101 / Future Medicine
Journal: Amzeeq (Minocycline Topical Foam): A New Drug for the Treatment of Acne. (Pubmed Central) - Feb 13, 2021
However, the development of bacterial resistance has reduced their use, thereby reducing options for many patients with acne. Minocycline 4% topical foam is a safe and effective alternative, which may help restore this important therapeutic approach for treating acne vulgaris.
- || Amzeeq (minocycline topical foam 4%) / Menlo Therap
FDA event: $VYNE VYNE Therapeutics Announces FDA Approval of AMZEEQ® (Minocycline) Label Update https://t.co/Ovib2d49iQ #fdaapproval (Twitter) - Feb 1, 2021
- | Winlevi (clascoterone cream 1%) / Cassiopea, Differin (adapalene) / Galderma
Journal: Drugs for acne. (Pubmed Central) - Jan 23, 2021
Minocycline 4% topical foam is a safe and effective alternative, which may help restore this important therapeutic approach for treating acne vulgaris. No abstract available
- | Amzeeq (minocycline topical foam 4%) / Fortress, Zilxi (minocycline topical foam 1.5%) / Fortress
New trial, Surgery: Topical Antisepsis in Head and Neck Cancer Surgery (clinicaltrials.gov) - Jan 21, 2021
P, N=25, Recruiting, Sponsor: Medical College of Wisconsin
- | minocycline / Generic mfg.
Journal: Susceptibility of Cutibacterium acnes to topical minocycline foam. (Pubmed Central) - Jan 9, 2021
Minocycline retained antibacterial activity against C. acnes over 15 multiple passages; thus, no selective growth advantage for minocycline-resistant mutants occurred under the experimental conditions. FMX101 4% has the potential to retain the favorable resistance profile of minocycline in diverse C. acnes isolates while providing the benefits of a topical formulation for treatment of acne vulgaris.
- Humira (adalimumab) / Eisai, AbbVie, Differin (adapalene) / Galderma, Cimzia (certolizumab pegol) / Astellas, UCB, Eli Lilly
[VIRTUAL] Therapeutic Update () - Nov 26, 2020 - Abstract #FCPANP2020FCPANP_61;
Similar concepts have allowed combination of halobetasol .01% and tazarotene .045%, calcipotriene as a foam and halobetasol as a lotion...Goldenberg also highlighted new topicals including tapinarof and a topical PDE-4 inhibitor, roflumilast...Goldenberg then summarized updates on biologics for the management of psoriasis including: the improved hemoglobin A1c and weight control in diabetic patients with psoriasis on Otezla (PDE-4 inhibitor); long-term safety of tumor necrosis factor biologics adalimumab and certolizumab pegol as well as the ability for patients to self-administer certolizumab at home; the enduring efficacy of IL-17 blockers including congruent patient-reported data for ixekizumab, sustained long-term response data for secukinumab to 52 weeks and for brodalumab to 60 weeks; data demonstrating that although IL-17 blockers (specifically secukinumab) may work faster, guselkumab had a higher proportion of patients reach PASI 90/100 by week 48 and that rizankizumab outperformed adalimumab in moderate to severe plaque psoriasis management; and finally promising results for tyrosine kinase 2 inhibitors improving quality of life in psoriasis patients...Goldenberg closed with a brief discussion of advancements in management of viral dermatoses (single-use cantharidin for molluscum, buccal-adhesive acyclovir tablets), personal care moisturizers, and augmenting sun protection with polypodium leucotomos. Overall, regardless of which niche in dermatology you practice in, there are sure to be exciting therapeutic advancements coming your way.
- Amzeeq (minocycline topical foam 4%) / Menlo Therap, FM101 / Future Medicine
[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 () - Nov 25, 2020 - Abstract #FCDC2020FCDC_239;
Overall, regardless of which niche in dermatology you practice in, there are sure to be exciting therapeutic advancements coming your way. Abstract not available.
- ||| minocycline / Generic mfg.
Clinical, P3 data, Journal: Efficacy and Safety of a Novel Topical Minocycline Foam for the Treatment of Moderate-to-Severe Acne Vulgaris: A Phase 3 Study. (Pubmed Central) - Nov 19, 2020
Abstract not available. FMX101 4% topical minocycline foam was effective and safe for the treatment of moderate to severe AV.
- | Amzeeq (minocycline topical foam 4%) / Menlo Therap, FM101 / Future Medicine
Journal: Formulation and Profile of FMX101 4% Minocycline Topical Foam for the Treatment of Acne Vulgaris. (Pubmed Central) - Nov 5, 2020
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.
- | Amzeeq (minocycline topical foam 4%) / Menlo Therap
Journal: Minocycline foam (Amzeeq) for acne. (Pubmed Central) - Sep 16, 2020
In conclusion, the topical formulation of minocycline in FMX101 4% represents a unique treatment for acne vulgaris and a viable alternative to oral administration. No abstract available
- Amzeeq (minocycline topical foam 4%) / Menlo Therap
[VIRTUAL] Efficacy of FMX101 4% topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Integrated summary from three phase 3 studies () - Jul 1, 2020 - Abstract #SID2020SID_473;
No abstract available FMX101 4% demonstrated statistically significant benefits compared to vehicle in treating moderate-to-severe acne vulgaris in the pooled population of 3 Phase 3 studies.
- | Amzeeq (minocycline topical foam 4%) / Menlo Therap
Journal: Evaluating FMX-101 as a promising therapeutic for the treatment of acne. (Pubmed Central) - Jun 8, 2020
The author then provides their expert opinion on this treatment and its potential for the treatment option for acne.Expert opinion: The topical foam formulation of FMX-101 has been shown to reduce both inflammatory and non-inflammatory lesions and to improve IGA scores in patients with moderate-to-severe acne without significant systemic absorption thus limiting associated side effects. Overall, the proven efficacy and safety profile of FMX-101, together with the low systemic absorption, high skin tolerability and cosmetically acceptable foam formulations render this novel therapy an important addition to the acne treatment armamentarium.
- || minocycline / Generic mfg., Amzeeq (minocycline topical foam 4%) / Menlo Therap
P1 data, Journal: Topical minocycline foam 4%: Results of four phase 1 studies evaluating the potential for phototoxicity, photoallergy, sensitization, and cumulative irritation. (Pubmed Central) - Mar 31, 2020
Few adverse events, mostly mild to moderate, were reported. In conclusion, FMX101 4% appeared to be well tolerated and non-irritating, and was considered to be non-sensitizing, non-phototoxic, and non-photoallergic.
- || Amzeeq (minocycline topical foam 4%) / Foamix
Clinical, Journal: Open-label Extension Study Evaluating Long-term Safety and Efficacy of FMX101 4% Minocycline Foam for Moderate-to-Severe Acne Vulgaris. (Pubmed Central) - Feb 13, 2020
Through Week 52, there were ongoing reductions in inflammatory lesions and increasing IGA treatment success. FMX101 4% minocycline foam appeared to be safe, effective, and well-tolerated for up to 52 weeks in the treatment of moderate-to-severe acne.
- | Amzeeq (minocycline topical foam 4%) / Fortress
New P1 trial: Dermal Phototoxicity Study (clinicaltrials.gov) - Aug 28, 2019
P1, N=32, Completed, Sponsor: Foamix Ltd.
- | Amzeeq (minocycline topical foam 4%) / Fortress
New P1 trial: Dermal Photo Allergic Skin Reaction (clinicaltrials.gov) - Aug 28, 2019
P1, N=56, Completed, Sponsor: Foamix Ltd.
- | Amzeeq (minocycline topical foam 4%) / Fortress
New P1 trial: Dermal Cumulative Irritant Patch Study (clinicaltrials.gov) - Aug 20, 2019
P1, N=42, Completed, Sponsor: Foamix Ltd.
- | Amzeeq (minocycline topical foam 4%) / Fortress
New P1 trial: A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design (clinicaltrials.gov) - Aug 11, 2019
P1, N=233, Completed, Sponsor: Foamix Ltd.
- | minocycline (BPX-01) / BioPharmX
Journal: Treating Acne With Topical Antibiotics: Current Obstacles and the Introduction of Topical Minocycline as a New Treatment Option (Pubmed Central) - Jul 19, 2019
J Drugs Dermatol. 2019;18(3):240-244.
- || FMX101 /
NDA: @bradloncar any thoughts on FOMX? Looks super cheap after a few blunders, and has an accepted NDA for FMX101 that should receive approval next March (Twitter) - Jul 17, 2019
- || Amzeeq (minocycline topical foam 4%) / Fortress
Trial completion: A Study Comparing Two Topicals in the Treatment of Acne Vulgaris (clinicaltrials.gov) - Apr 4, 2019
P1, N=12, Completed, Sponsor: Foamix Ltd.
2019;18(3):240-244. Recruiting --> Completed
- Amzeeq (minocycline topical foam 4%) / Fortress
Phase classification: A Study Comparing Two Topicals in the Treatment of Acne Vulgaris (clinicaltrials.gov) - Dec 10, 2018
P1, N=10, Recruiting, Sponsor: Foamix Ltd.
Recruiting --> Completed Phase classification: P4 --> P1
- | Amzeeq (minocycline topical foam 4%) / Fortress
New P1 trial, New P4 trial: A Study Comparing Two Topicals in the Treatment of Acne Vulgaris (clinicaltrials.gov) - Nov 15, 2018
P4, N=10, Recruiting, Sponsor: Foamix Ltd.
- | Amzeeq (minocycline topical foam 4%) / Fortress
Trial completion: A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris (clinicaltrials.gov) - Oct 30, 2018
P3, N=1507, Completed, Sponsor: Foamix Ltd.
Phase classification: P4 --> P1 Active, not recruiting --> Completed
- ||||||| Amzeeq (minocycline topical foam 4%) / Fortress
Trial completion: A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne (clinicaltrials.gov) - Mar 19, 2018
P3, N=450, Completed, Sponsor: Foamix Ltd.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||||||| Amzeeq (minocycline topical foam 4%) / Fortress
Trial completion: A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne (clinicaltrials.gov) - Mar 16, 2018
P3, N=450, Completed, Sponsor: Foamix Ltd.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| Amzeeq (minocycline topical foam 4%) / Fortress
New P3 trial: A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris (clinicaltrials.gov) - Aug 31, 2017
P3, N=1500, Recruiting, Sponsor: Foamix Ltd.
- ||||| Amzeeq (minocycline topical foam 4%) / Fortress
Enrollment closed, Trial primary completion date: A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne (clinicaltrials.gov) - Aug 23, 2017
P3, N=450, Active, not recruiting, Sponsor: Foamix Ltd.
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2017 --> Nov 2017
- ||||| Amzeeq (minocycline topical foam 4%) / Fortress
Enrollment closed, Trial primary completion date: A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne (clinicaltrials.gov) - Aug 23, 2017
P3, N=450, Active, not recruiting, Sponsor: Foamix Ltd.
Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2017 --> Nov 2017 Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2017 --> Nov 2017
- |||||||||| Amzeeq (minocycline topical foam 4%) / Fortress
New P3 trial: A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne (clinicaltrials.gov) - Jun 28, 2016
P3, N=450, Recruiting, Sponsor: Foamix Ltd.
- |||||||||| Amzeeq (minocycline topical foam 4%) / Fortress
New P3 trial: A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne (clinicaltrials.gov) - Jun 28, 2016
P3, N=450, Recruiting, Sponsor: Foamix Ltd.
- | Amzeeq (minocycline topical foam 4%) / Fortress
Trial completion: A Pharmacokinetic Study of Minocycline in Male and Female Volunteers (clinicaltrials.gov) - Aug 26, 2015
P1, N=12, Completed, Sponsor: Foamix Ltd.
Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2017 --> Nov 2017 Not yet recruiting --> Completed
- | Amzeeq (minocycline topical foam 4%) / Fortress
New P1 trial: A Pharmacokinetic Study of Minocycline in Male and Female Volunteers (clinicaltrials.gov) - Sep 28, 2014
P1, N=12, Not yet recruiting, Sponsor: Foamix Ltd.