dermaprazole / Baylor College of Medicine - LARVOL DELTA

Efficacy of Esomeprazole Cream in Preventing Radiation-Induced Dermatitis in Cancer Patients. (PubMed, J Pain Symptom Manage) - "Administration of 2% esomeprazole cream to head and neck cancer patients undergoing radiotherapy appears to reduce RID severity and delay onset, with favorable effects on several cutaneous symptoms. Further larger, multicenter trials are warranted to confirm these findings and to evaluate long-term outcomes and quality of life."

Clinical • Journal • Dermatitis • Dermatology • Head and Neck Cancer • Immunology • Oncology • Pain • Solid Tumor

Topical Dermaprazole for Radiation Dermatitis in Breast Cancer Patients (TOPAZ) (clinicaltrials.gov) - P1/2 | N=3 | Terminated | Sponsor: Baylor College of Medicine | N=37 ➔ 3 | Recruiting ➔ Terminated; PI is leaving institution and this protocol will not be further pursued at this institution.

Enrollment change • Trial termination • Breast Cancer • Dermatitis • Dermatology • Immunology • Oncology • Solid Tumor

Topical Dermaprazole for Radiation Dermatitis in Breast Cancer Patients (TOPAZ) (clinicaltrials.gov) - P1/2 | N=37 | Recruiting | Sponsor: Michelle S Ludwig | N=57 ➔ 37 | Trial completion date: Jan 2027 ➔ Jan 2028 | Trial primary completion date: Jan 2025 ➔ Jan 2026

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Dermatitis • Dermatology • Head and Neck Cancer • Immunology • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer (clinicaltrials.gov) - P2 | N=6 | Completed | Sponsor: The University of Texas Health Science Center at San Antonio | Active, not recruiting ➔ Completed

Trial completion • Dermatitis • Dermatology • Head and Neck Cancer • Immunology • Oncology • Solid Tumor

Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer (clinicaltrials.gov) - P2 | N=6 | Active, not recruiting | Sponsor: The University of Texas Health Science Center at San Antonio | Recruiting ➔ Active, not recruiting | N=45 ➔ 6 | Trial completion date: Sep 2028 ➔ Aug 2024 | Trial primary completion date: Sep 2027 ➔ Aug 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Dermatitis • Dermatology • Head and Neck Cancer • Immunology • Oncology • Solid Tumor

Pumping Up Dermatologic Drug Reformulation: A Novel Phase II/III Clinical Trial of Topically Reformulated Proton-Pump-Inhibitor Esomeprazole for Prevention and Treatment of Radiation Dermatitis in Breast Cancer (AAD 2024) - "Our preclinical studies show that the topically reformulated proton-pump-inhibitor (PPI) esomeprazole (Dermaprazole) can effectively treat radiation-induced skin morphea due to its potent anti-inflammatory and anti-fibrotic effects in animal models. Treatment-related adverse effects such as burning, pruritus, tenderness, rash, and other local/systemic reactions will be assessed. The results of this study may directly impact clinical practice and help reduce radiation-related dermatitis while increasing adherence to the prescribed dose of radiotherapy."

Clinical • P2/3 data • Breast Cancer • Dermatitis • Dermatology • Fibrosis • Genetic Disorders • Immunology • Oncology • Pruritus • Scleroderma • Skin Cancer • Solid Tumor • Systemic Sclerosis

Topical Dermaprazole for Radiation Dermatitis in Breast Cancer and Head and Neck Cancer Patients (TOPAZ) (clinicaltrials.gov) - P1/2 | N=57 | Recruiting | Sponsor: Michelle S Ludwig

Trial completion date • Trial primary completion date • Breast Cancer • Dermatitis • Dermatology • Head and Neck Cancer • Immunology • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Topical Dermaprazole for Radiation Dermatitis in Breast Cancer and Head and Neck Cancer Patients (TOPAZ) (clinicaltrials.gov) - P1/2 | N=57 | Recruiting | Sponsor: Michelle S Ludwig | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Dermatitis • Dermatology • Head and Neck Cancer • Immunology • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Topical Dermaprazole for Radiation Dermatitis in Breast Cancer and Head and Neck Cancer Patients (TOPAZ) (clinicaltrials.gov) - P1/2 | N=57 | Not yet recruiting | Sponsor: Michelle S Ludwig | Initiation date: Dec 2022 ➔ Mar 2023

Trial initiation date • Breast Cancer • Dermatitis • Dermatology • Head and Neck Cancer • Immunology • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Topical Dermaprazole for Radiation Dermatitis in Breast Cancer and Head and Neck Cancer Patients (TOPAZ) (clinicaltrials.gov) - P1/2 | N=57 | Not yet recruiting | Sponsor: Michelle S Ludwig | Initiation date: Jul 2022 ➔ Dec 2022

Trial initiation date • Breast Cancer • Dermatitis • Dermatology • Head and Neck Cancer • Immunology • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Dermaprazole Cream for Radiation Dermatitis in Definitive Head and Neck Cancer (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: The University of Texas Health Science Center at San Antonio | Trial completion date: Sep 2027 ➔ Sep 2028 | Trial primary completion date: Sep 2026 ➔ Sep 2027

Trial completion date • Trial primary completion date • Dermatitis • Dermatology • Head and Neck Cancer • Immunology • Oncology • Solid Tumor

Dermaprazole Cream for Radiation Dermatitis in Definitive Head and Neck Cancer (clinicaltrials.gov) - P2 | N=45 | Recruiting | Sponsor: The University of Texas Health Science Center at San Antonio | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatitis • Dermatology • Head and Neck Cancer • Immunology • Oncology • Solid Tumor