A Split-Face, Single-Blind, Study Assessing the Use of a Topical Antioxidant Containing Silymarin With A Series of 1726nm Laser Procedures to Reduce Sebum Production

This is a split-face, single-blind study assessing the use of an antioxidant serum with a series of acne laser treatments to reduce sebum production in healthy male and female subjects between the ages of 18 and 65 years, inclusive, with Fitzpatrick skin types I-VI.

开始日期2024-04-24

申办/合作机构

The Austin Institute For Clinical Research

[+1]

NCT05932732 / Completed临床4期IIT

A Phase IV Open-label Trial Assessing the Impact on Skin Quality, Hydration, and Barrier of Three (3) Hydrafacial Treatments in Adults of Fitzpatrick Skin Types I-VI

This is a phase IV, unblinded, open-label study assessing the impact on skin quality, hydration, and barrier of three (3) Hydrafacial treatments in healthy adults of Fitzpatrick Skin Types I & II, III, IV, V & VI, 30 to 55 years of age. Efficacy and subject satisfaction will be assessed, before and after three (3) HF treatments, in 6 patient cohorts, each cohort defined by FST I-VI.

开始日期2023-11-20

申办/合作机构

The Austin Institute For Clinical Research

[+1]

NCT06090071 / Completed临床4期IIT

A Phase 4, Single-Site Study Assessing Improvement of Skin Discoloration and Texture With Combination Treatment of Novel Moisturizer and Non-Ablative Laser Treatment Inclusive of Fitzpatrick Skin Types I-VI and Asian Descent

This is a phase 4 trial evaluating the clinical effect of combining a placebo moisturizer and non-ablative laser to improve procedural outcomes in patients with facial dyschromia. This study's objective is to evaluate both the tolerability and improvement in signs of photoaging for a placebo moisturizer used in combination with a non-ablative laser. Physician assessments, patient reported outcomes, and digital photos will be captured.

开始日期2023-11-14

申办/合作机构

The Austin Institute For Clinical Research

[+1]

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2024-12-01·JAAD International

Safety and tolerability of tirbanibulin ointment 1% treatment on 100 cm2 of the face or scalp in patients with actinic keratosis: A phase 3 study

Article

作者: Jarell, Abel ; DuBois, Janet ; Padullés, Laura ; Tamarit, Maria Luisa ; Bhatia, Neal ; Blauvelt, Andrew ; Otero, Raquel ; Lain, Edward ; Falques, Meritxell ; Kiyasova, Vera

BackgroundTirbanibulin is approved for actinic keratosis (AK) field treatment up to 25 cm². However, AK often affects larger areas; thus, AK treatments for larger fields are needed.ObjectiveEvaluate the safety and tolerability of tirbanibulin when applied to a field of approximately 100 cm².MethodsPhase 3, multicenter, open-label, single-arm study among adult patients having a treatment field on the face or balding scalp of approximately 100 cm² with 4-12 AKs. Patients received tirbanibulin to cover the treatment field once daily (5 consecutive days). Safety was assessed by evaluating treatment emergent adverse events and tolerability by composite score of 6 local tolerability signs (LTS).ResultsA total of 105 patients were included. The most common LTS were erythema (96.1%) and flaking/scaling (84.4%), being mostly mild-to-moderate severity, and resolved/returned to or close to baseline by Day 29. The only severe LTS were erythema (5.8%) and flaking/scaling (8.7%). Most frequent treatment emergent adverse events were application site pruritus (10.5%) and application site pain (8.6%). Mean total number of AKs decreased from 7.7 AKs at baseline to 1.8 AKs at Day 57. Mean percent of change (reduction) from baseline in lesion count was 77.8% at Day 57.LimitationsNo control group. No long-term follow-up.ConclusionSafety and tolerability profiles in patients treated with tirbanibulin up to 100 cm² were consistent with those previously reported over smaller field. Tirbanibulin could be used on a larger field (>25 cm²).

2024-10-01·Dermatology and Therapy

Efficacy of Brodalumab in Patients with Psoriasis and Risk Factors for Treatment Failure: A Review of Post Hoc Analyses

Review

作者: Lebwohl, Mark G ; Armstrong, April W ; Alexis, Andrew F ; Lain, Edward L ; Jacobson, Abby A

Factors such as obesity, alcohol consumption, and tobacco use are associated with both increased psoriasis severity and inadequate response to systemic and biologic therapies. Obesity is linked to chronic inflammation, which can contribute to psoriasis pathogenesis. Fixed-dose therapies may have reduced efficacy in patients with a higher body mass index, while weight-based dosing can increase the burden of drug-specific side effects. Alcohol and nicotine from tobacco have also been shown to stimulate keratinocyte and immune cell proliferation and production of proinflammatory cytokines. While these risk factors are prevalent among patients with moderate-to-severe psoriasis, their influence on treatment outcomes may be overlooked when evaluating therapeutic options. Brodalumab is a fully human interleukin-17 receptor A antagonist approved for the treatment of moderate-to-severe psoriasis. In this review, we describe the lifestyle-related risk factors associated with decreased response to treatment. We further summarize the post hoc analyses of brodalumab in participant subgroups with moderate-to-severe psoriasis and a history of prior biologic failure, obesity, and alcohol or tobacco use from two phase 3 clinical trials (AMAGINE-2 and AMAGINE-3; ClinicalTrials.gov identifiers: NCT01708603 and NCT01708629, respectively). Our review of clinical trial and real-world data suggests that brodalumab is an efficacious and safe treatment option for patients with lifestyle factors that increase the likelihood of treatment failure, allowing them to achieve skin clearance and improve quality of life.

2024-08-08·British Journal of Dermatology

724 - A phase 2b, randomized, double-blinded, parallel-group, placebo-controlled study to evaluate the efficacy and safety of rezpegaldesleukin in adults with severe to very-severe alopecia areata

作者: Schleicher, Stephen ; Kwiek, Bartlomiej ; Chaudhry, Sohail ; Zalevsky, Jonathan ; Szepietowski, Jacek C ; Baran, Wojciech ; Mellskog, Katie ; Reich, Adam ; Rosmarin, David ; Rodgers, Timothy G ; Lee, Zachary ; Osman, Lawrence ; Zdybski, Jacek ; Xu, Heng ; Lewis, Brian ; Torz, Michal ; Fanton, Christie ; Lain, Edward ; Lynde, Charles W ; Owczarczyk-Saczonek, Agnieszka ; Liu, Yi ; Tagliaferri, Mary ; Sadick, Neil ; Elko-Simms, Lucinda M

AbstractIntroduction & ObjectivesAlopecia areata (AA) is a chronic inflammatory skin disorder resulting in patchy, non-scaring hair loss. The pathogenesis for AA involves loss of immune privilege for the hair follicle through overactivity of the Th1 and Th17 cells and dysfunction of regulatory T cells (Treg).1 Rezpegaldesleukin (REZPEG: NKTR-358) is a polyethylene glycol (PEG)-conjugated recombinant human interleukin 2 (rhIL-2) with the ability to selectively promote the activation and up-to 12-fold expansion of Tregs, while having relatively minimal effect on conventional T cells (Tcons).2 REZPEG is a biologic therapy and represents a potential novel therapeutic approach for patients with severe to very-severe AA. There are currently no biologic therapies approved for the treatment of AA. REZPEG has previously demonstrated clinical activity in patients with chronic inflammatory skin conditions, including atopic dermatitis (AD), psoriasis, and systemic lupus erythematous. Specifically, a Phase 1b study of REZPEG for patients with moderate-to-severe AD demonstrated a rapid time to response (2-4 weeks) during induction therapy and a prolonged durability of response, i.e., throughout the 36-week follow-up after cessation of therapy. These results support further development of REZPEG for patients with moderate to severe AD (phase 2b study ongoing, NCT06136741) and other inflammatory skin diseases, including AA.ObjectiveEvaluate the efficacy and safety of REZPEG in patients with severe alopecia areata.Materials & MethodsWe are conducting a Phase 2b, randomized, double-blinded, placebo-controlled, international, multicenter study of REZPEG vs placebo for JAK-inhibitor naïve patients with severe to very severe AA. Eligibility requires adult males (aged 18-60 years) or adult females (aged 18-70) with severe to very severe AA with the following inclusion criteria: baseline Severity Alopecia Tool (SALT) score ≥ 50, stable hair loss for 6-months, current episode of severe AA of less than 8-years, and no hair loss from causes other than AA. Patients will be randomly assigned in a 3:3:2 ratio to 2 different REZPEG dosing regimens vs. placebo, administered subcutaneously, during the treatment period and all patients will undergo an extended follow-up. The primary endpoint for this study is the percent change from baseline in SALT score at end of treatment period. Key secondary/exploratory endpoints include the following: percent change from baseline in SALT score at other assessed timepoints, proportions with ≥ 50%, 75%, 90% reduction in SALT at end of treatment period and other assessed timepoints, proportion of patients with absolute SALT score ≤ 10, ≤ 20, ≤ 30, ≤ 50 at end of treatment period and other assessed timepoints, safety/tolerability, various patient reported outcomes (PROs), pharmacokinetics, and pharmacodynamics.ResultsTrial ongoing (NCT 06340360).ConclusionREZPEG is a novel regulatory T cell stimulating therapy that may confer prolonged therapeutic benefit for patients with chronic inflammatory skin conditions, including AA and AD. This phase 2b trial is evaluating the efficacy and safety of multiple dosing regimens of REZPEG in JAK-inhibitor and biologic-therapy naïve patients with severe to very severe alopecia areata.

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