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A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer

NCT05190770 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-12-03

Study results available
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Summary

The purpose of this study is find out whether Oleogel-S10 is an effective treatment for radiation dermatitis when it is used in combination with a standard wound treatment cream called triamcinolone. Oleogel-S10 has shortened the healing time for other types of skin wounds such as burns. Triamcinolone is a cream that is frequently used to treat moderate to severe skin conditions such as skin irritation caused by poison ivy, eczema, sunburn, and rashes.

Conditions

  • Breast Cancer
  • Breast Cancer Stage
  • Breast Cancer Stage I
  • Breast Cancer Stage II
  • Breast Cancer Stage III
  • Breast Cancer Stage IV

Interventions

DRUG

Triamcinolone Acetonide

Triamcinolone acetonide is a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. It is applied topically.

DRUG

Oleogel-S10

Oleogel-S10 consists of birch bark extract (TE): 10 mg/100 mg; Sunflower oil, refined: 90 mg/100 mg. It is applied topically.

Sponsors & Collaborators

Principal Investigators

  • Alina Markova, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2024-08-27
Completion
2024-08-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05190770 on ClinicalTrials.gov