Dermaprazole 1% for Radiation Skin Damage

Baylor St. Luke's Medical Center, Houston, TX
Radiation Skin Damage+2 More ConditionsDermaprazole 1% - Drug
Eligibility
18 - 100
All Sexes

Study Summary

This trial is studying a prophylactic cream to see if it can help prevent skin damage caused by radiation therapy in patients with breast or head and neck cancer.

Eligible Conditions
  • Radiation Skin Damage
  • Breast Cancer
  • Head and Neck Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: at before and after Dermaprazole cream application at the CT simulation visit, weekly during radiation treatment up to 7 weeks, 1 and 6 month follow-up after completion of all radiation therapy

Month 6
Median of the peak score of each QOL component
Week 7
Number of missed treatments due to skin toxicity
Rate of clinically bothersome radiation dermatitis at maximum feasible dose in phase II
Month 1
Number of participants with Dose-Limiting Toxicity(DLT) in phase I
Month 6
Median- occurrence time of grade 2 or higher acute radiation dermatitis
Median-healing time of grade 2 or higher acute radiation dermatitis develops
Rate of grade 2 or higher acute radiation dermatitis

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

4 Treatment Groups

Dermaprazole 1% (Arm A:Head and neck)
1 of 4
Dermaprazole 2% (Arm B: Breast)
1 of 4
Dermaprazole 2% (Arm A: Head and neck)
1 of 4
Dermaprazole 1% (ArmB: Breast)
1 of 4

Experimental Treatment

57 Total Participants · 4 Treatment Groups

Primary Treatment: Dermaprazole 1% · No Placebo Group · Phase 1 & 2

Dermaprazole 1% (Arm A:Head and neck)
Drug
Experimental Group · 1 Intervention: Dermaprazole 1% · Intervention Types: Drug
Dermaprazole 2% (Arm B: Breast)
Drug
Experimental Group · 1 Intervention: Dermaprazole 2% · Intervention Types: Drug
Dermaprazole 2% (Arm A: Head and neck)
Drug
Experimental Group · 1 Intervention: Dermaprazole 2% · Intervention Types: Drug
Dermaprazole 1% (ArmB: Breast)
Drug
Experimental Group · 1 Intervention: Dermaprazole 1% · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at before and after dermaprazole cream application at the ct simulation visit, weekly during radiation treatment up to 7 weeks, 1 and 6 month follow-up after completion of all radiation therapy

Who is running the clinical trial?

Michelle S LudwigLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Michelle S Ludwig, MD, MPH, PhDPrincipal InvestigatorBaylor College of Medicine
1 Previous Clinical Trials
24 Total Patients Enrolled

Eligibility Criteria

Age 18 - 100 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
This study is specifically for people with head and neck cancer.
This study has a specific group for participants with breast cancer called Arm B.

Frequently Asked Questions

Are there still spots available for volunteers in this research project?

"Unfortunately, this study is not currently accepting patients. Although the trial was last updated on September 14th, 2022, it was originally posted on December 1st, 20212. There are 3387 other clinical trials that are still recruiting patients." - Anonymous Online Contributor

Unverified Answer

What are the aims of this experiment?

"The purpose of this clinical trial, which will be conducted over the course of 7 weeks with weekly evaluations, is to study the effect of the medication on patients. The primary outcome measure is the number of participants who experience dose-limiting toxicity. Secondary outcomes include median healing time for grade 2 or higher acute radiation dermatitis, rate of occurrence for grade 2 or higher acute radiation dermatitis, and rate of grade 2 or higher acute radiation dermatitis." - Anonymous Online Contributor

Unverified Answer

Am I eligible to participate in this research?

"This study is recruiting 57 patients with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) who are aged 18-100. Participants must also meet the following criteria: Arm B: Breast cancer arm, Histological diagnosis of invasive ductal or lobular carcinoma (diagnosed within 2 years of enrollment), Planned to receive adjuvant chest wall radiation of at least 40Gy or higher biologically equivalent dose (BED), Age 18 years or older, Written Informed Consent, History and Physical within 12 weeks of enrollment, Arm A: Head & Neck cancer arm, Patients with squamous cell carcinoma of the head and neck confirmed with institutional pathology (diagnosed within 2 years" - Anonymous Online Contributor

Unverified Answer

Does this research project include people who are under the age of 75 years old?

"This study is looking for adult participants between the ages of 18-100." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.