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Proton Pump Inhibitor

Dermaprazole Cream for Radiation Dermatitis

Phase 2

Recruiting

Led By Mohamad A Fakhreddine, MD

Research Sponsored by Mohamad Hassan Fakhreddine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with head and neck malignancy (including radiation therapy to primary head cancers of any histology and/or neck lymphatics, excluding brain malignancies)

Planned to receive definitive chemoradiation of at least 66Gy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

Study Summary

This trial will study whether a new PPI cream is safe and effective in treating head and neck cancer patients.

Who is the study for?

This trial is for adults over 18 with head and neck cancer, excluding brain malignancies, who are set to receive at least 66Gy of chemoradiation. They should have a performance status that allows daily activities (ECOG 0-2) and no prior treatments like head and neck radiotherapy or neoadjuvant chemotherapy. Those taking proton pump inhibitors must stop with their doctor's approval.Check my eligibility

What is being tested?

The study tests Dermaprazole cream against Aquaphor in preventing radiation dermatitis during cancer treatment. It aims to see if the reformulated proton pump inhibitor cream is safe and effective for patients undergoing definitive chemoradiation therapy for head and neck cancers.See study design

What are the potential side effects?

While specific side effects of Dermaprazole aren't detailed here, similar creams may cause skin reactions such as redness, itching, or rash. Patients might also experience typical side effects from radiation like dryness or peeling skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a cancer in my head or neck area, but not in my brain.

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I am scheduled for a specific cancer treatment with radiation.

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I have a confirmed diagnosis of head and neck cancer from a biopsy.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rates of clinically significant radiation dermatitis as defined as NCI CTCAE version 5 grade 2 or higher

Side effects data

From 2020 Phase 4 trial • 66 Patients • NCT03094416

Upper respiratory tract infection

Diarrhoea

Nausea

Vomiting

Constipation

Gastroenteritis

Subcutaneous abscess

Hyperlipidaemia

Cough

Bronchitis

Urinary tract infection

Musculoskeletal pain

Dizziness

Asthma

Arthralgia

Back pain

100%

80%

60%

40%

20%

Study treatment Arm

Treatment Period: Tirosint Capsules

Run-in Period: LT4 Tablets

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DermaprazoleExperimental Treatment1 Intervention

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

Group II: AquaphorActive Control1 Intervention

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mohamad Hassan FakhreddineLead Sponsor

The University of Texas Health Science Center at San AntonioLead Sponsor

452 Previous Clinical Trials

91,365 Total Patients Enrolled

Mohamad A Fakhreddine, MDPrincipal InvestigatorThe University of Texas Health Science Center - Mays Cancer Center

Media Library

Dermaprazole Cream (Proton Pump Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04865731 — Phase 2

Dermaprazole Cream (Proton Pump Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04865731 — Phase 2

Head and Neck Cancers Clinical Trial 2023: Dermaprazole Cream Highlights & Side Effects. Trial Name: NCT04865731 — Phase 2

Head and Neck Cancers Research Study Groups: Dermaprazole, Aquaphor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What precedent has been established for the use of Dermaprazole in medical research?

"Currently, there are 23 ongoing clinical trials investigating the potential of Dermaprazole with 4 studies in their final Phase 3. While a majority of these investigations are located in Baltimore, Maryland, 40 distinct medical centres have been recruited to help advance this research."

Answered by AI

Has the FDA approved Dermaprazole for general use?

"The safety profile of dermaprazole was rated a 2 out of 3, as there is data present regarding its protective effects but no instances demonstrating efficacy."

Answered by AI

To what ailments is Dermaprazole commonly recommended?

"Dermaprazole is commonly prescribed to treat stress ulcers; yet, it can also be utilized as a therapeutic agent for hemorrhage, pruritus, and Helicobacter pylori infection."

Answered by AI

To what extent is this research study assessing the effects on participants?

"Indeed, according to the clinicaltrials.gov website, this trial is currently recruiting patients with 45 participants required from a single medical facility. The study was first uploaded on June 15th 2022 and most recently amended on June 17th 2022."

Answered by AI

Are there any open spots for participation in this research endeavor?

"According to clinicaltrials.gov, this ongoing research program is actively seeking qualified candidates; it was posted on June 15th 2022 and last revised two days later."

Answered by AI

Is this experimental research unprecedented in its approach?

"Since 2010, the Livzon Pharmaceutical Group Inc. have been researching Dermaprazole and its applications in healthcare, beginning with a Phase 1 trial of 330 participants. Following this successful completion of these initial studies, it was later given approval to proceed into Phase 2 trials. Currently there are 23 ongoing experiments being conducted across numerous cities and 11 countries globally."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer

Mohamad Hassan Fakhreddine 2022. "Dermaprazole Cream for Radiation Dermatitis in Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04865731.

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