Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Wounds and Injuries

Breast Neoplasms

Dermatitis

Radiodermatitis

Breast Diseases

Skin Diseases

Radiation Injuries

Anti-Inflammatory Agents

All Drugs and Chemicals

Antineoplastic Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Herbal and Botanical

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Prednisolone

Glucocorticoids

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Mineralocorticoids

Hormones

Hormone Antagonists

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

Sunflower

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.

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 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.

Oleogel-S10

Alina Markova, MD

Mario Lacouture, MD

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.

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

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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.

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer	NCT05190770	Breast Cancer Breast Cancer S... Breast Cancer S... Breast Cancer S... Breast Cancer S... Breast Cancer S...	Triamcinolone A... Oleogel-S10	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer	NCT05190770	Breast Cancer Breast Cancer S... Breast Cancer S... Breast Cancer S... Breast Cancer S... Breast Cancer S...	Triamcinolone A... Oleogel-S10	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for pmrt

Every month we try and update this database with for pmrt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pmrt

Every month we try and update this database with for pmrt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pmrt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.