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

NCT05190770 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 21-091
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Radiation Dermatitis; PMRT; Breast cancer; Oleogel-S10; Triamcinolone acetonide; Memorial Sloan Kettering Cancer Center; 21-091

Outcome Measures

Primary Outcomes (1)

• Wound Surface Area Reduction of Radiation Dermatitis Grade 2-3 Wound Size From Baseline to Day 14 (+/- 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.

  14 days from baseline (+/- 3 days)

Study Arms (2)

Triamcinolone + Oleogel-S10

EXPERIMENTAL

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.

Drug: Triamcinolone Acetonide; Drug: Oleogel-S10

Triamcinolone + Placebo

PLACEBO COMPARATOR

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.

Drug: Triamcinolone Acetonide

Interventions

Triamcinolone Acetonide DRUG

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

Triamcinolone + Oleogel-S10; Triamcinolone + Placebo

Oleogel-S10 DRUG

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

Triamcinolone + Oleogel-S10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are receiving PMRT to the chest wall or post-lumpectomy RT to the whole breast cancer of any stage
• Age ≥ 18 years
• Patients who develop ARD grade 2/3 after fraction day 20 (when receiving 25 total fractions) or after fraction day 25 when receiving (30 total fraction inclusive of a 5 fraction boost) of radiation therapy with all locations of desquamation
• Able to self-administer topical interventions or provide for another person to apply the topical intervention
• Patients may be started on any topicals prior to study enrollment. Once patient is enrolled on study (on or before Day 1), patient must be able to discontinue other topicals (including topical steroids, Silvadene, calcineurin inhibitors) to the treatment area
• Patients have completed surgery or chemotherapy ≥ 4 weeks prior to start of radiation therapy. Patients may receive antibody-drug conjugates at any time before/during/after study
• Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 0) and documented monthly.
• WCBP must agree to abstrain from sex or use a highly effective method of birth control\* from the time of consent through visit 5.
• Adequate contraceptive methods include those with a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as abstinence from sexual intercourse, and some double barrier methods (condom with spermicide) in conjunction with use by the partner of an intrauterine device, diaphragm with spermicide, oral contraceptives, birth control patch or vaginal ring, or injectable or implanted contraceptives. Abstinence is acceptable only as true abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• A woman that is postmenopausal (≥2 years since last menstrual period) or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) is not considered a WCBP.

You may not qualify if:

• Patients who are receiving radiation therapy for inflammatory breast cancer or malignant fungating wound
• Known history of allergy to any ingredient of the study medication
• Patients with collagen-vascular disease/vasculitis
• Patients receiving hypofractionated radiation therapy
• Special populations:
• patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (4)

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Alina Markova, MD
• Organization: Memorial Sloan Kettering Cancer Center

markovaa@mskcc.org

646-608-2342

Study Officials

• Alina Markova, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 13, 2022
• Study Start: December 15, 2021
• Primary Completion: August 27, 2024
• Study Completion: August 27, 2024
• Last Updated: December 3, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (4)