Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Acute Graft Versus Host Disease

HylaCare cream Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily, but not within 4 hours prior to radiation treatment.

HylaCare

Placebo

Asal Rahimi, MD

This will be a randomized, double blind, vehicle-controlled evaluation of the effectiveness and safety of HylaCareTM. The study will employ the patient as her own control, a commonly used method for the evaluation of topical dermatologic agents. Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily.

Patients will be allocated to the treatment using a randomized permuted block. There will be no stratification. Patients will be randomized to receive the investigational product to be applied to either the medial (inside) or lateral (outside) portion of the breast, a placebo product will be used on the other side. Patients and clinical investigators will be blinded to the treatment assignments.

HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer

Randomized, Double-Blind, Vehicle-Controlled Pilot Study of the Efficacy and Safety of HylaCareTM in the Treatment of Acute Skin Changes in Patients Undergoing External Beam Radiotherapy for Tumors of the Breast.

NCI-CTC (National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity.

NCI-CTC(National Cancer Institute-Common Terminology Criteria) version 4.0 was used to assessed acute skin toxicity grade by physician. Toxicity grade range from Grade 0 to Grade 5, with higher grade indicating worst skin toxicity.

Investigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with 0 = normal skin

1. = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema
2. = erythema with dry desquamation
3. = wet desquamation \</= 2 cm
4. = wet desquamation from 2.1 - 5cm
5. = wet desquamation from 5.1 - 9 cm
6. = wet desquamation \> 9.1 cm

Investigator Grading Scale is used to assessed acute skin toxicity. Score range from grade 0 to 6 with

0 = normal skin

1. = light epidermal irritation, consisting of the onset of erythema, possibly associated with slight edema
2. = erythema with dry desquamation
3. = wet desquamation \</= 2 cm
4. = wet desquamation from 2.1 - 5cm
5. = wet desquamation from 5.1 - 9 cm
6. = wet desquamation \> 9.1 cm

Acute skin toxicity, as measured by number of participants with skin reactions via self assessment

University of Texas Southwestern Medical Center

Associate Professor of Medicine

Expected adverse event due to radiation with and without the skin cream (Hylacare).

* Erythema
* Pain
* Tenderness
* Irritability
* Burning
* Dryness
* Hypersensitivity
* Hair loss

Expected adverse event due to radiation with and without the skin cream (Hylacare).

* Erythema
* Pain
* Tenderness
* Irritability
* Burning

Expected Adverse Events With and Without Skin Cream(Hylacare)

HylaCare cream-Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily, but not within 4 hours prior to radiation treatment. The patient is her own control.

Hylacare-Experimental

Age, Continuous

Sex: Female, Male

Sarmistha Sen

Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within four hours prior to radiation treatment. Each patient will use both HA study cream and placebo.

All 28 patients were assigned to both arms HA formulation (Hylacare study cream) on the medial or lateral half of the irradiated breast and the control cream (placebo) on the other half. Each patient will use both HA study cream and placebo cream on breast receiving radiation treatment.

Acute Skin Toxicity Per NCI-CTC v4.0

HylaCare cream Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily, but not within 4 hours prior to radiation treatment.

HylaCare: cream

The patient is her own control.

Placebo: placebo

Acute Skin Toxicity Per Investigator Grading Scale

We only analyzed data that were available

Acute Skin Toxicity, as Measured by Number of Participants With Skin Reactions

Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the other breast in the same fashion, as a further control. The study drug and placebo will be applied three times daily, but not within 4 hours prior to radiation treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer	NCT02165605	Breast Cancer	HylaCare Placebo	18 Years - 99 Years	University of Texas Southwestern Medical Center
HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer	NCT02165605	Breast Cancer	HylaCare Placebo	18 Years - 99 Years	University of Texas Southwestern Medical Center

Spots Global Cancer Trial Database for hylacare

Every month we try and update this database with for hylacare 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 hylacare

Every month we try and update this database with for hylacare 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 hylacare 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.