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Oleogel-S10 + Standard Cream for Radiation Dermatitis

Phase 2
Recruiting
Led By Alina Markova, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who are receiving PMRT to the chest wall or post-lumpectomy RT to the whole breast cancer of any stage
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days from baseline (+/- 3 days)
Awards & highlights

Study Summary

This trial will test whether Oleogel-S10 can speed up the healing of radiation dermatitis when used with the standard treatment cream triamcinolone.

Who is the study for?
This trial is for adults over 18 with any stage of breast cancer who are undergoing radiation therapy and have developed moderate to severe skin irritation (grade 2/3) during treatment. They must not be using other topical treatments, have finished surgery or chemotherapy at least four weeks prior, and if they can become pregnant, agree to effective birth control.Check my eligibility
What is being tested?
The study tests Oleogel-S10 gel combined with triamcinolone cream against radiation dermatitis in breast cancer patients. Oleogel-S10 may speed up healing of skin wounds like burns, while triamcinolone treats various severe skin conditions.See study design
What are the potential side effects?
Possible side effects include allergic reactions to ingredients in the medications, increased risk of infection due to open skin wounds from dermatitis, and typical steroid-related effects such as thinning of the skin or changes in pigmentation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am receiving radiation therapy for breast cancer after surgery.
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I am using a highly effective form of birth control or am not of childbearing potential.
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I can stop using other skin treatments once I join the study.
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I can apply medicine to my skin myself or have someone who can do it for me.
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I developed moderate to severe skin reactions during days 20-25 of my radiation therapy.
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I finished surgery or chemotherapy more than 4 weeks ago.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days from baseline (+/- 3 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days from baseline (+/- 3 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction of radiation dermatitis grade 2-3 wound size from baseline to day 14 (+/- 3 days)

Side effects data

From 2022 Phase 3 trial • 223 Patients • NCT03068780
61%
Wound complication
8%
Pyrexia
7%
Pruritus
7%
Wound infection
7%
Anaemia
4%
Wound infection staphylococcal
3%
Cough
3%
Wound infection bacterial
3%
Nasopharyngitis
2%
Dysphagia
2%
Influenza
2%
Diarrhoea
1%
Squamous cell carcinoma skin
1%
Wound haemorrhage
1%
Haematuria
1%
Pneumonia
1%
Device related infection
1%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oleogel-S10 (DBP)
Control Gel (DBP)
Former Oleogel-S10 (OLP)
Former Control Gel (OLP)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Triamcinolone + Oleogel-S10Experimental Treatment2 Interventions
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.
Group II: Triamcinolone + PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oleogel-S10
2010
Completed Phase 3
~260
Triamcinolone Acetonide
2018
Completed Phase 4
~3730

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,930 Previous Clinical Trials
597,328 Total Patients Enrolled
202 Trials studying Breast Cancer
95,119 Patients Enrolled for Breast Cancer
Alina Markova, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
7 Previous Clinical Trials
797 Total Patients Enrolled

Media Library

Oleogel-S10 Gel (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05190770 — Phase 2
Breast Cancer Research Study Groups: Triamcinolone + Placebo, Triamcinolone + Oleogel-S10
Breast Cancer Clinical Trial 2023: Oleogel-S10 Gel Highlights & Side Effects. Trial Name: NCT05190770 — Phase 2
Oleogel-S10 Gel (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05190770 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the primary indications for Oleogel-S10?

"ulcerative colitis, hand, and brain patients can all benefit from Oleogel-S10 treatment."

Answered by AI

In how many different areas is this study being conducted?

"This study is enrolling patients from a total of 6 sites, 3 of which are in Middletown, Basking Ridge and New york. The other locations include: ____, ____, ____. It might be helpful for you to pick the location nearest you to limit travel time if you do decide to participate."

Answered by AI

Has Oleogel-S10 passed government testing for safety?

"While there is some safety data available for Oleogel-S10, it did not yet receive a score of 3 because efficacy has not been proven in clinical trials."

Answered by AI

How many willing participants are being taken in for this experiment?

"That is correct. If you consult clinicaltrials.gov, you will see that this trial was initially posted on December 15th 2021 and is still recruiting patients. They are looking for a total of 50 individuals spread out across 6 different locations."

Answered by AI

Are we still able to sign up for this clinical trial?

"That is correct. The clinicaltrials.gov website indicates that this trial, which was first posted on December 15th 2021, is still looking for patients. 50 individuals are needed across 6 different locations for the study."

Answered by AI

Could you please give us a rundown of other medical research involving Oleogel-S10?

"195 clinical trials have been completed testing Oleogel-S10 since it was first studied in 2005 by Hamid Ahmadieh, MD. As of now, there are 48 ongoing studies with several based out of Middletown, New jersey."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
~27 spots leftby Dec 2026