Duobrii (halobetasol/tazarotene) / 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-118 Lotion in Pediatric Participants With Plaque Psoriasis (clinicaltrials.gov) - P4 | N=45 | Recruiting | Sponsor: Bausch Health Americas, Inc. | Trial completion date: Jun 2024 ➔ Mar 2027 | Trial primary completion date: Jun 2024 ➔ Feb 2027

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

Resolving Hyperkeratotic Psoriasis: Mechanisms of Action and Additive Effects of Fixed-Combination Halobetasol Propionate and Tazarotene. (PubMed, J Drugs Dermatol) - "This review suggests that HP/TAZ is a valuable option for the topical treatment of severe hyperkeratotic plaques through its additive mechanisms targeting inflammation and keratinocyte regulation."

Journal • Review • Dermatology • Immunology • Oncology • Psoriasis • IL17A • TNFA

Halobetasol Propionate/Tazarotene Lotion for Scalp Psoriasis: Efficacy in Itch Reduction, Disease Clearance, and Hair Appearance. (PubMed, J Drugs Dermatol) - "No adverse events were reported. HP/TAZ is an efficacious treatment for scalp psoriasis, and reductions in psoriatic disease and itch may reduce scratching, leading to improvements in hair and scalp health."

Clinical • Journal • Alopecia • Dermatology • Immunology • Psoriasis

Clinical Profile of Halobetasol Propionate 0.01%/ Tazarotene 0.045% Lotion in Patients With Hyperkeratotic Plaque Psoriasis. (PubMed, J Drugs Dermatol) - "HP/TAZ was efficacious and well tolerated for treating hyperkeratotic plaques."

Clinical • Journal • Dermatology • Immunology • Psoriasis

A Canadian Real-World Study of Fixed-DOSE combination of Halobetasol Propionate 0.01%/Tazarotene 0.045% Lotion for the Treatment of Moderate-to-Severe Plaque Psoriasis. (PubMed, Clin Ther) - "Results confirm that HP/TAZ can be beneficial moderate-to-severe psoriasis patients."

Journal • Real-world evidence • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • 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

Investigator Initiated Trial to Study Duobrii® Lotion in the Treatment of Mild Plaque Psoriasis in Adults (clinicaltrials.gov) - P3 | N=21 | Completed | Sponsor: Austin Institute for Clinical Research | Recruiting ➔ Completed | N=40 ➔ 21

Enrollment change • Trial completion • Dermatology • Immunology • Psoriasis

Canadian Expert Consensus on the Use of Halobetasol Propionate/Tazarotene Lotion for Plaque Psoriasis. (PubMed, Dermatol Ther (Heidelb)) - "Expert panel members agreed, based on the existing body of literature, that there is a place in therapy for HP/TAZ to address several current unmet treatment needs of patients with plaque psoriasis. Studies have shown that HP/TAZ is an effective and safe first-line treatment for moderate-to-severe plaque psoriasis. Due to its cosmetically pleasing vehicle and once-daily administration, HP/TAZ may improve patient acceptance and treatment adherence."

Journal • Dermatology • Immunology • Psoriasis

Early and Sustained Efficacy of Fixed-Combination Halobetasol Propionate and Tazarotene Lotion in Participants with Moderate-to-Severe Scaling or Plaque Elevation (AAD 2024) - "HP/TAZ was associated with clinically meaningful, early, and sustained skin clearance in participants with hyperkeratotic psoriasis, as defined by moderate to severe scaling or plaque elevation, which is often difficult to treat."

Clinical • Dermatology • Immunology • Psoriasis

Fixed-Combination Halobetasol Propionate 0.01%/Tazarotene 0.045% and Halobetasol Propionate 0.01% Lotions for Plaque Psoriasis on Lower Extremities With Body Hair (AAD 2024) - P3 | "This post hoc analysis demonstrates that HP/TAZ and HP lotions are effective and safe at treating plaque psoriasis of the leg on males, a body area historically difficult to treat due to the presence of hair."

Dermatology • Immunology • Psoriasis

A Demonstration of the Hair and Scalp Benefits of Duobrii in Scalp Psoriasis (clinicaltrials.gov) - P4 | N=20 | Completed | Sponsor: Dermatology Consulting Services, PLLC | Recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion in Psoriasis (clinicaltrials.gov) - P4 | N=10 | Completed | Sponsor: Dermatology Consulting Services, PLLC | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis • IL17A • TNFA

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

Eight-year-old with pityriasis rubra pilaris, disguised as spongiotic dermatitis (ASDP 2023) - "She trialed oral antibiotics, antihistamines, and topical anti-inflammatory agents (hydrocortisone ointment 2.5%, calcipotriene cream 0.005%, halobetasol propionate-tazarotene cream 0.01-0.045%, tacrolimus 0.03% ointment) without improvement...She was subsequently started on dupilumab and received three doses; despite this treatment, had progression of her symptoms...Our case underscores the importance of clinical and dermatopathology congruency in informing treatment and management. Poster type: Poster Defense"

Allergy • Dermatitis • Dermatology • Dermatomyositis • Dermatopathology • Immunology • Infectious Disease • Inflammation • Influenza • Musculoskeletal Diseases • Musculoskeletal Pain • Myositis • Novel Coronavirus Disease • Orthopedics • Pain • Respiratory Diseases

Noncorticosteroid Topical Therapies for the Treatment of Plaque Psoriasis: A Narrative Review. (PubMed, J Pharm Technol) - "Data Sources: A literature search of the PubMed database was performed (January 1978 to May 2023) using the keywords plaque psoriasis, tapinarof, benvitimod, Vtama, roflumilast, Zoryve, pimecrolimus, tacrolimus, tazarotene, tacalcitol, calcitriol, Vectical, calcipotriene, Dovonex, tacalcitol, vitamin D analogs, salicylic acid, non-corticosteroid topical, Investigator's Global Assessment, and Physician's Global Assessment...The percentage of patients with plaque psoriasis who achieved Investigator's Global Assessment (IGA) success after 8 weeks of treatment with tacalcitol, calcipotriene/betamethasone dipropionate compound, tazarotene/halobetasol propionate, and roflumilast was 17.9%, 39.9%, 40.7%, and 42.4%, respectively...Each topical was efficacious in treating plaque psoriasis and had an adequate safety profile. Despite several treatment options for plaque psoriasis, medication adherence is a limiting factor."

Journal • Review • Dermatology • Immunology • Psoriasis

Anti-Inflammatory Effects of 0.045% Tazarotene/0.01% Halobetasol Lotion in Psoriasis (clinicaltrials.gov) - P4 | N=10 | Active, not recruiting | Sponsor: Dermatology Consulting Services, PLLC

New P4 trial • Dermatology • Immunology • Psoriasis • IL17A • TNFA

Fixed-combination halobetasol propionate and tazarotene topical lotion decreases TNF-α and IL-17A levels in psoriatic lesions. (PubMed, J Dermatolog Treat) - "HP/TAZ significantly reduced TNF-α levels at weeks 4 through 12 (p < 0.03) and IL-17A levels at weeks 2 through 8 (p < 0.05) in treated compared with untreated plaques. HP/TAZ was highly effective in treating psoriasis plaques and, although HP/TAZ is not a biologic, effectively reduced cytokine-associated inflammatory markers that drive psoriatic disease."

Journal • Dermatology • Immunology • Inflammation • Oncology • Psoriasis • IL17A • TNFA

A Safety and Pharmacokinetics Study of IDP-118 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

Investigator Initiated Trial to Study Duobrii® Lotion in the Treatment of Mild Plaque Psoriasis in Adults (clinicaltrials.gov) - P3 | N=40 | Recruiting | Sponsor: Austin Institute for Clinical Research | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Sep 2022 ➔ Sep 2023

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

A Demonstration of the Hair and Scalp Benefits of Duobrii in Scalp Psoriasis (clinicaltrials.gov) - P4 | N=20 | Recruiting | Sponsor: Dermatology Consulting Services, PLLC

New P4 trial • Dermatology • Immunology • Psoriasis

Canadian Expert Consensus on Use of Halobetasol Propionate/Tazarotene Lotion for Plaque Psoriasis (ISPOR 2023) - "Expert panel members agreed, based on the existing body of literature, that there is a place in therapy for HP/TAZ to address several current unmet treatment needs of patients with plaque psoriasis."

Dermatology • Immunology • Psoriasis

Cost-Effectiveness Analysis of Halobetasol and Tazarotene (DUOBRIITM) Compared to Standard of Care for Adult Patients with Moderate-to-Severe Plaque Psoriasis in Québec (ISPOR 2023) - "The SoC (betamethasone/calcipotriol [BD/VDA] followed by [>] systemic therapy [ST]; [BD/VDA>ST]) was compared to HP/TAZ>ST. Considering the chronic nature of plaque psoriasis, adding HP/TAZ to SoC would lead to considerable long-term savings in Quebec while improving population health."

Clinical • Cost effectiveness • HEOR • Dermatology • Immunology • Psoriasis

Fixed-Combination Halobetasol Propionate and Tazarotene Topical Lotion Decreases Interleukin-17A Levels in Psoriasis (AAD 2023) - "The efficacy of HP/TAZ coincides with a statistically significant decrease in IL-17A, a cytokine also targeted by injectable biologic therapies. These results suggest that HP/TAZ reduces cytokine-associated inflammation in psoriatic plaques."

Dermatology • Immunology • Inflammation • Psoriasis • IL17A