Skin and Connective Tissue Diseases

All Conditions

Neoplasms

Wounds and Injuries

Dermatitis

Head and Neck Neoplasms

Radiodermatitis

Skin Diseases

Radiation Injuries

Gastrointestinal Agents

All Drugs and Chemicals

Dermatologic Agents

Esomeprazole

Petrolatum

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

30 HNC patients who will be using Dermaprazole twice daily for 7 weeks

15 HNC patients using Aquaphor, the current clinical standard of care

Patients will be managed with twice daily prophylactic use of the proposed intervention (Dermaprazole) topical cream for radiation dermatitis. The amount of cream will be 2cc per application and will be measured in pre-filled capped syringes for every application.

Dermaprazole

Patients will be managed with twice daily prophylactic use of Aquaphor. The amount of Aquaphor will be 2cc per application and will be measured in pre-filled capped syringes for every application.

Aquaphor

Epp Goodwin

Timothy Wagner, MD

Carol Jenkins, RN

In this study, the study team seek to conduct a pilot clinical study to evaluate the safety and efficacy of a reformulated proton pump inhibitor (PPI) cream (Dermaprazole) in definitive head and neck cancer (HNC) patients.

Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer

A Phase II Clinical Trial of Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer Patients (CTMS# 20-0147)

Number of adverse events defined by the NCI CTCAE rated 3 or higher

The University of Texas Health Science Center at San Antonio

Breast Neoplasms

Antineoplastic Agents

Silybin

Emollients

Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor

Difinsa53 cream is applied to one half of radiation field

Difinsa53

Aquaphor is applied to one half of radiation field

Joshua Petit, MD

Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying, ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing whole breast radiation.

The proposed study seeks to evaluate the efficacy of DIFINISA53™, a safe silibin-based skin cream, on preventing radiation dermatitis (RD) when compared to an over the counter ointment, Aquaphor, in women undergoing radiation therapy for breast cancer following lumpectomy or mastectomy surgery. Presently there is no known fully effective topical protectant from RD and there is no consensus among radiation oncologists on how best to treat RD. This study seeks to identify a more effective option for patients receiving radiation therapy. Each participant will apply the DIFINISA53™ cream to one area of the treated skin and Aquaphor to another area of treated skin. Skin reactions will be evaluated using medical professional assessment, participant assessment, and photographic assessment by a third party.

Topical Use of Difinsa53™ to Prevent Radiation Dermatitis

Topical Use of a Silibin-based Cream, Difinsa53™, to Prevent Radiation Dermatitis in Patients With Breast Cancer: A Prospective Study

A blinded observer will quantify degree of dermatitis assigning each half of the radiation field a score from 0 to 4. 0 represents no dermatitis and 4 is severe dermatitis using the RTOG scoring criteria.

Poudre Valley Health System

ProTechSure Scientific, Inc.

Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor

Difinsa53: Difinsa53 cream is applied to one half of radiation field

Difinsa53 Arm

Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor

Aquaphor: Aquaphor is applied to one half of radiation field

Aquaphor Arm

Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor

Difinsa53: Difinsa53 cream is applied to one half of radiation field

Aquaphor: Aquaphor is applied to one half of radiation field

Difinsa53 and Aquaphor Arms

Age, Categorical

Participants

Sex: Female, Male

The analysis population consisted of 13 breast cancer patients receiving radiation to a breast. Each breast was divided into two radiation fields, one defined as the Difinsa53 arm and the other as the Aquaphor Arm. Thus each participant contributed data from two fields.

This trial was terminated early, based on minimal radiation dermatitis (scores of 0-1 only in most fields evaluated) that precluded any meaningful analysis of any differing effect in the two treatment arms.

L. Michael Glode, MD

Difinsa 53 Arm

All patients were analyzed by blinded observor

Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria

This radiation field treated with aquaphor

This radiation field treated with Difinsa53

Overall Study

Studied products will be applied as per the patient information leaflet following manufacturer guidelines to the treatment area. The studied products will be used starting on the first day of radiation therapy. The studied products will be applied twice a day to both the right and left inguinal regions. The studied products will be used daily during the entire course of radiotherapy including on weekends and holidays until at least 4 weeks upon completion of radiation therapy or otherwise until resolution of RD on both sides.

Studied products will be applied as per the patient information leaflet following manufacturer guidelines to the treatment area. The studied products will be used starting on the first day of radiation therapy. The studied products will be applied twice a day to the entire treatment field. The studied products will be used during the entire course of radiotherapy and for a further 4 weeks upon completion of radiation therapy.

StrataXRT is a full contact flexible wound dressing for the prevention and treatment of radiation dermatitis. StrataXRT is a semi-occlusive, self-drying and transparent gel.

When used as directed StrataXRT dries to form a protective layer that is gas permeable and waterproof which hydrates and protects compromised skin areas and superficial wounds from chemical and microbial invasion. StrataXRT may be directly applied to radiation dermatitis, compromised skin surfaces, superficial wounds and first and second degree burns.

StrataXRT

Aquaphor is a brand of over-the-counter (OTC) skin care ointments manufactured by Beiersdorf Inc.

Aquaphor contains 41 percent petrolatum (or petroleum jelly), the active ingredient, temporarily protects minor cuts, scrapes, and burns; protects and helps relieve chapped or cracked skin and lips; helps protect from the drying effects of wind and cold weather.

Carolina Rojas

The aim of this study is to assess the efficacy and safety of StrataXRT® in comparison to standard of care (defined using the Common Terminology Criteria for Adverse Events \[CTCAE\], version 5.0) by assessing the severity of inguinal RD in patients receiving elective radiation therapy +/- systemic therapy to the bilateral inguinal nodes.

StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis

StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis in Cancer Patients Receiving Elective Inguinal Radiation Therapy

The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD (19). This instrument is routinely used and well validated in radiation oncology for assessing radiation dermatitis (20). This weekly assessment will be undertaken by the assessor who is blinded to the allocation. The assessor will be instructed prior to the first fraction of radiation therapy to score the worst toxicity present, at the time of assessment within the treatment field which consists of the bilateral inguinal regions.

The amount of \> grade 2 RD cases will be compared in both study groups.

The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD. Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.

The repeated measurements average toxicity will be compared in both study groups.

The Common Terminology Criteria for Adverse Events (CTCAE- Version 5.0) will be used to assess the severity of RD.Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.

The time to moist desquamation will be compared in both study groups.

The participant will be asked to rate their pain level at the irradiated area. The time of interest of the original VAS is modified from "the past 24 hours" to "the past 7 days" for the specific purpose of this study. The VAS has been selected as it is a brief and easy tool for the assessment of pain within both the clinical and research settings. It has been well validated in both the chronic pain and cancer settings. The scale of 0 to 10 is simple for patients to use and reflects common clinical assessment of pain.

Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.

The average pain will be compared in both study groups. The worst pain will be compared in both study groups. Pain relief will be measured in the repeated measurements analysis.

Itching will be scored on a numeric analogue scale of 0-10 in the treated skin (0= no itching at all), (10= itching as bad as you can imagine). Patients will be assessed in a repeated measurement model following the visits calendar. The assessments will be pooled based on their visit week and cumulative dose.

The average pain will be compared in both study groups. The worst pain will be compared in both study groups. Pain relief will be measured in the repeated measurements analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer	NCT04865731	Cancer of the H...	Dermaprazole Aquaphor	18 Years -	The University of Texas Health Science Center at San Antonio
Topical Use of Difinsa53™ to Prevent Radiation Dermatitis	NCT02534129	Radiodermatitis	Difinsa53 Aquaphor	-	ProTechSure Scientific, Inc.
Topical Use of Difinsa53™ to Prevent Radiation Dermatitis	NCT02534129	Radiodermatitis	Difinsa53 Aquaphor	-	ProTechSure Scientific, Inc.
StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis	NCT05553392	Radiation Derma...	StrataXRT Aquaphor	18 Years -	Stratpharma AG
StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis	NCT05553392	Radiation Derma...	StrataXRT Aquaphor	18 Years -	Stratpharma AG
Topical Use of Difinsa53™ to Prevent Radiation Dermatitis	NCT02534129	Radiodermatitis	Difinsa53 Aquaphor	-	ProTechSure Scientific, Inc.

Spots Global Cancer Trial Database for aquaphor

Every month we try and update this database with for aquaphor cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for aquaphor

Every month we try and update this database with for aquaphor cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for aquaphor cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.