CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 11 enrolled
Drug / intervention
Topical Dapsone 5% Gel +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01931150
NCT01931150Phase 3Completed

A Phase III Randomized Double-blind Study of Prophylactic Topical Dapsone 5% Gel Versus Moisturizer for Cetuximab-induced Papulopustular (Acneiform) Rash in Patients With mCRC or HNSCC Without Previous or Concurrent RT

Memorial Sloan Kettering Cancer Center·interventional·Posted Aug 29, 2013·Updated Jan 13, 2017

In Brief

A Phase 3 clinical trial evaluating Topical Dapsone 5% Gel, Moisturizer, and 1 other intervention for Cetuximab-induced Papulopustular (Acneiform) Rash Who Have and Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The purpose of this study is to see if the investigators can prevent or reduce the severity of the Cetuximab-related acne rash. Two different topical agents will be applied to the skin. One topical agent is the dapsone gel and the other is a skin moisturizer. Dapsone gel is an FDA approved medication that you apply to the face. It is commonly used to treat acne. Skin moisturizers are recommended to patients who receive Cetuximab treatment. In addition to these topical agents they will be given a pill to take once a day. This pill has already been shown to help fight rashes from Cetuximab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 29, 2013
Enrollment StartAug 1, 2013
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.8 years ago

Interventions

Topical Dapsone 5% Geldrug

Moisturizerother

The moisturizer for the study will be Vanicream™ Lite Lotion.

oral antibioticsdrug