Trial Outcomes & Findings for A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer (NCT NCT05190770)
NCT ID: NCT05190770
Last Updated: 2025-12-03
Results Overview
The primary outcome of this study is the efficacy of Oleogel-S10 in reducing radiation dermatitis grade 2-3 wound size in patient with breast cancer undergoing external beam radiation therapy. Clinical assessment at all study visits, including wound surface area and adverse events will be performed by a dermatologist. Wound size will be measured using a HIPAA compliant 3D clinical imaging system.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
14 days from baseline (+/- 3 days)
Results posted on
2025-12-03
Participant Flow
Participant milestones
| Measure |
Triamcinolone + Oleogel-S10
25 participants will be randomized to triamcinolone 0.1% cream once every morning and topical Oleogel-S10 gel once prior to bedtime for a 3 week period.
Triamcinolone Acetonide: Triamcinolone acetonide is a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. It is applied topically.
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.
|
Triamcinolone + Placebo
25 patients with breast cancer will be randomized to triamcinolone 0.1% cream once every morning (QAM) and vehicle gel once prior to bedtime for a 3 week period.
Triamcinolone Acetonide: Triamcinolone acetonide is a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. It is applied topically.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer
Baseline characteristics by cohort
| Measure |
Triamcinolone + Oleogel-S10
n=9 Participants
25 participants will be randomized to triamcinolone 0.1% cream once every morning and topical Oleogel-S10 gel once prior to bedtime for a 3 week period.
Triamcinolone Acetonide: Triamcinolone acetonide is a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. It is applied topically.
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.
|
Triamcinolone + Placebo
n=9 Participants
25 patients with breast cancer will be randomized to triamcinolone 0.1% cream once every morning (QAM) and vehicle gel once prior to bedtime for a 3 week period.
Triamcinolone Acetonide: Triamcinolone acetonide is a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. It is applied topically.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
n=9 Participants
|
56 years
n=6 Participants
|
47 years
n=9 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
18 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
17 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
17 Participants
n=9 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 14 days from baseline (+/- 3 days)The primary outcome of this study is the efficacy of Oleogel-S10 in reducing radiation dermatitis grade 2-3 wound size in patient with breast cancer undergoing external beam radiation therapy. Clinical assessment at all study visits, including wound surface area and adverse events will be performed by a dermatologist. Wound size will be measured using a HIPAA compliant 3D clinical imaging system.
Outcome measures
| Measure |
Triamcinolone + Oleogel-S10
n=9 Participants
25 participants will be randomized to triamcinolone 0.1% cream once every morning and topical Oleogel-S10 gel once prior to bedtime for a 3 week period.
Triamcinolone Acetonide: Triamcinolone acetonide is a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. It is applied topically.
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.
|
Triamcinolone + Placebo
n=9 Participants
25 patients with breast cancer will be randomized to triamcinolone 0.1% cream once every morning (QAM) and vehicle gel once prior to bedtime for a 3 week period.
Triamcinolone Acetonide: Triamcinolone acetonide is a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. It is applied topically.
|
|---|---|---|
|
Wound Surface Area Reduction of Radiation Dermatitis Grade 2-3 Wound Size From Baseline to Day 14 (+/- 3 Days)
Baseline
|
10.3 cm^2
Standard Deviation 16.8
|
25.3 cm^2
Standard Deviation 65.2
|
|
Wound Surface Area Reduction of Radiation Dermatitis Grade 2-3 Wound Size From Baseline to Day 14 (+/- 3 Days)
Day 14
|
0.5 cm^2
Standard Deviation 0.8
|
4.1 cm^2
Standard Deviation 10.0
|
Adverse Events
Triamcinolone + Oleogel-S10
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Triamcinolone + Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Triamcinolone + Oleogel-S10
n=9 participants at risk
25 participants will be randomized to triamcinolone 0.1% cream once every morning and topical Oleogel-S10 gel once prior to bedtime for a 3 week period.
Triamcinolone Acetonide: Triamcinolone acetonide is a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. It is applied topically.
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.
|
Triamcinolone + Placebo
n=9 participants at risk
25 patients with breast cancer will be randomized to triamcinolone 0.1% cream once every morning (QAM) and vehicle gel once prior to bedtime for a 3 week period.
Triamcinolone Acetonide: Triamcinolone acetonide is a derivative of prednisolone with high glucocorticoid activity and low mineralocorticoid activity. It is applied topically.
|
|---|---|---|
|
Infections and infestations
Skin infection
|
22.2%
2/9 • 14 days from baseline
|
0.00%
0/9 • 14 days from baseline
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
11.1%
1/9 • 14 days from baseline
|
0.00%
0/9 • 14 days from baseline
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alina Markova, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-2342
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place