Trials / Completed
CompletedNCT05190770
A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-12-15
- Primary completion
- 2024-08-27
- Completion
- 2024-08-27
- First posted
- 2022-01-13
- Last updated
- 2025-12-03
- Results posted
- 2025-09-11
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05190770. Inclusion in this directory is not an endorsement.