At a glance
ClinicalIndex Comparison Record- ✓Receiving postmastectomy radiation therapy (PMRT) to chest wall or post-lumpectomy radiation therapy to whole breast for breast cancer of any stage
- ✓Age ≥18 years
- ✓Development of acute radiation dermatitis (ARD) grade 2/3 after fraction day 20 (for 25 total fractions) or day 25 (for 30 total fractions including 5-fraction boost)
- ✓Able to self-administer or have another person apply topical intervention
- ✕Receiving radiation therapy for inflammatory breast cancer or malignant fungating wound
- ✕Known allergy to any ingredient of study medication
- ✕History of collagen-vascular disease or vasculitis
- ✕Receiving hypofractionated radiation therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase II Double-Blinded Study of The Efficacy of Oleogel-S10 (AP101) Gel for the Treatment of Grade 2/3 Radiation Dermatitis in Breast Cancer Patients
In Brief
A Phase 2 clinical trial evaluating Triamcinolone Acetonide and Oleogel-S10 for Breast Cancer and 5 related conditions. Completed, enrolled 18 participants across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
Triamcinolone acetonide is a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. It is applied topically.
Oleogel-S10 consists of birch bark extract (TE): 10 mg/100 mg; Sunflower oil, refined: 90 mg/100 mg. It is applied topically.