Jemdel (halobetasol propionate topical) / Bausch Health - LARVOL DELTA

Duobrii Treatment of Acne Keloidalis Nuchae (AKN) (clinicaltrials.gov) - P3 | N=15 | Terminated | Sponsor: Icahn School of Medicine at Mount Sinai | N=30 ➔ 15 | Active, not recruiting ➔ Terminated; Interim analysis did not show any significant differences between groups

Enrollment change • Trial termination • Acne Vulgaris • Fibrosis

A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis (clinicaltrials.gov) - P4 | N=45 | Recruiting | Sponsor: Bausch Health Americas, Inc. | Trial completion date: Jun 2024 ➔ Jun 2026 | Trial primary completion date: Jun 2024 ➔ May 2026

Trial completion date • Trial primary completion date • Dermatology • Immunology • Pediatrics • Psoriasis

Duobrii Treatment of Acne Keloidalis Nuchae (AKN) (clinicaltrials.gov) - P3 | N=30 | Active, not recruiting | Sponsor: Icahn School of Medicine at Mount Sinai | Recruiting ➔ Active, not recruiting

Enrollment closed • Acne Vulgaris • Fibrosis

Duobrii Treatment of Acne Keloidalis Nuchae (AKN) (clinicaltrials.gov) - P3 | N=30 | Recruiting | Sponsor: Icahn School of Medicine at Mount Sinai | Trial completion date: Oct 2024 ➔ Jul 2025 | Trial primary completion date: Oct 2024 ➔ Jul 2025

Trial completion date • Trial primary completion date • Acne Vulgaris • Fibrosis

Duobrii Treatment of Acne Keloidalis Nuchae (AKN) (clinicaltrials.gov) - P3 | N=30 | Recruiting | Sponsor: Icahn School of Medicine at Mount Sinai | Trial completion date: Oct 2023 ➔ Oct 2024 | Trial primary completion date: Oct 2023 ➔ Oct 2024

Trial completion date • Trial primary completion date • Acne Vulgaris • Fibrosis

A Practical Guide to Advanced Topical Drug Delivery Systems in Dermatology. (PubMed, Skin Therapy Lett) - "Awareness of the delivery system in which drugs are formulated is critical as this can have profound implications on treatment success. This paper provides an overview and clinical commentary on advances in topical delivery systems and their impact on dermatological practice."

Journal • Metastases • Acne Vulgaris • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Psoriasis

A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis (clinicaltrials.gov) - P4 | N=45 | Recruiting | Sponsor: Bausch Health Americas, Inc. | Trial completion date: Jun 2023 ➔ Jun 2024 | Trial primary completion date: Jun 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • Dermatology • Immunology • Pediatrics • Psoriasis

A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis (clinicaltrials.gov) - P4 | N=45 | Recruiting | Sponsor: Bausch Health Americas, Inc. | Trial completion date: Dec 2022 ➔ Jun 2023 | Trial primary completion date: Dec 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • Dermatology • Immunology • Pediatrics • Psoriasis

"$BHC Bausch Health Wins DUOBRII(R) and BRYHALI(R) Patent Infringement Case https://t.co/j4ugry0GFL #patent" (@stock_titan)

Duobrii Treatment of Acne Keloidalis Nuchae (AKN) (clinicaltrials.gov) - P3 | N=30 | Recruiting | Sponsor: Icahn School of Medicine at Mount Sinai

New P3 trial • Acne Vulgaris • Fibrosis

A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis (clinicaltrials.gov) - P4 | N=45 | Recruiting | Sponsor: Bausch Health Americas, Inc. | Trial completion date: Feb 2022 ➔ Dec 2022 | Trial primary completion date: Feb 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Dermatology • Immunology • Pediatrics • Psoriasis

Halobetasol Propionate 0.01% Lotion for Plaque Psoriasis and Corticosteroid-Responsive Dermatoses. (PubMed, Skin Therapy Lett) - "A novel topical corticosteroid, halobetasol propionate (HP) 0.01% lotion (Bryhali™), has recently been introduced for the treatment of plaque psoriasis and corticosteroid-responsive dermatoses in adults...No treatment-related cases of skin atrophy have been reported from the studies. Counselling should be considered to optimize treatment outcomes."

Journal • Dermatology • Immunology • Psoriasis

Double Blind Study on the Safety and Efficacy of CITI-002 in Adult Patients With Moderate Grade Hemorrhoids. (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Citius Pharmaceuticals, Inc.

New P2 trial • Gastroenterology • Gastrointestinal Disorder

A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis (clinicaltrials.gov) - P4; N=45; Recruiting; Sponsor: Bausch Health Americas, Inc.; Trial completion date: Jul 2021 ➔ Feb 2022; Trial primary completion date: Jul 2021 ➔ Feb 2022

Clinical • Trial completion date • Trial primary completion date • Dermatology • Immunology • Pediatrics • Psoriasis

Fixed-Combination Halobetasol Propionate and Tazarotene in the Treatment of Psoriasis: Narrative Review of Mechanisms of Action and Therapeutic Benefits. (PubMed, Dermatol Ther (Heidelb)) - "This new formulation technology allows for more uniform and efficient delivery of the active ingredients at lower doses than conventional monotherapy formulations of either ingredient while providing enhanced hydration and moisturization. This review provides an up-to-date overview of the therapeutic mechanisms of action of HP and TAZ, the rationale behind the development of HP 0.01%/TAZ 0.045% lotion, and clinical trials data on the efficacy, safety and tolerability, and maintenance of therapeutic effect with HP 0.01%/TAZ 0.045% lotion in the treatment of moderate-to-severe plaque psoriasis."

Journal • Review • Dermatology • Immunology • Psoriasis

A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis (clinicaltrials.gov) - P4; N=45; Recruiting; Sponsor: Bausch Health Americas, Inc.; Trial completion date: Jul 2020 ➔ Jul 2021; Trial primary completion date: Jul 2020 ➔ Jul 2021

Clinical • Trial completion date • Trial primary completion date • Dermatology • Dermatopathology • Immunology • Pediatrics • Psoriasis

Bausch Health announces resolution of Bryhali (halobetasol propionate) lotion, 0.01%, intellectual property litigation with Glenmark (PRNewswire) - "Bausch Health Companies...Ortho Dermatologics...have agreed to resolve the outstanding intellectual property litigation with Glenmark Pharmaceuticals, Ltd. (Glenmark), regarding BRYHALI® (halobetasol propionate) Lotion, 0.01%. The Company will grant Glenmark a non-exclusive license effective 2026 to its intellectual property relating to BRYHALI Lotion in the United States....Glenmark acknowledges the validity of the licensed patents. Final patent expiry on BRYHALI Lotion is 2031."

Patent

A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis (clinicaltrials.gov) - P4; N=45; Recruiting; Sponsor: Bausch Health Americas, Inc.; Initiation date: Jun 2019 ➔ Oct 2019

Clinical • Trial initiation date

Bausch Health's Ortho Dermatologics business to present data at the Fall Clinical Dermatology Conference (PRNewswire) - "Bausch Health Companies...Ortho Dermatologics...today announced the presentation of 18 posters during the Fall Clinical Dermatology Conference in Las Vegas (Oct. 17-20, 2019). The presentations will feature analyse...BRYHALI® (halobetasol propionate 0.01%) Lotion, DUOBRII® (halobetasol propionate 0.01% and tazarotene 0.045%) Lotion and SILIQ (brodalumab) injection, as well as a new data on the investigational drug IDP-123 (tazarotene 0.045%) Lotion."

Clinical data • P3 data • Retrospective data

A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis (clinicaltrials.gov) - P4; N=45; Recruiting; Sponsor: Bausch Health Americas, Inc.

Clinical • New P4 trial