Skin and Connective Tissue Diseases

All Conditions

Neoplasms

Wounds and Injuries

Dermatitis

Breast Neoplasms

Radiodermatitis

Breast Diseases

Skin Diseases

Radiation Injuries

Anti-Infective Agents

Antineoplastic Agents

Gastrointestinal Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Herbal and Botanical

Acemannan

Biafine

Fat Emulsions, Intravenous

Parenteral Nutrition Solutions

Adjuvants, Immunologic

Immunologic Factors

Antiviral Agents

Aloe

RadiaAce Gel is a clear, non-oily Hydrogel wound dressing for the management of Radiation Dermatitis which provides optimal moist wound environment necessary to the healing process. RadiaAce gel contains Acemannan, a high molecular polysaccharide obtained from the inner gel of Aloe Vera leaves and it is considered the main functional component of Aloe vera (Sahu et al. 2013).

one of the standard skin care in radiation oncology, this treatment was chosen as the comparator.

Patients will apply the RadiaAce to the treatment area starting 5 days before radiation treatment. The Hydrogel/cream will be applied three times a day with a minimum of four hours between applications. Treatments will be used through the course of RT and for 6 days after the last fraction of radiation.

RadiaAce gel

Patients will apply the Biafine to the treatment area starting 5 days before radiation treatment. The Hydrogel/cream will be applied three times a day with a minimum of four hours between applications. Treatments will be used through the course of RT and for 6 days after the last fraction of radiation.

Sivan Luder, VP R&D

Dana Shwartz, CA

Hava Evelyn Klotz

Meirav Ben David, MD

Radiation dermatitis (RD) is one of the most common side effects of Radiation therapy (RT) and 95% of patients receiving RT may experience some form of radiation dermatitis.

A wide variety of topical, oral, and intravenous agents are used to prevent/treat Radiation dermatitis but currently there is no gold standard in the prevention and management of this condition and no treatment can be explicitly recommended.

RadiaAce Gel is a wound dressing Hydrogel (Acemannan Hydrogel) for the management of RD which provides optimal moist wound environment necessary to the healing process.

Based on its composition as well as the supporting data on safety and performance of the functional ingredient Acemannan in wound healing, RadiaAce may well be suited to complement the prevention and therapy of radiation dermatitis.

The primary aim of the study is to evaluate the safety and performance of RadiaAce as compare to Biafine in reducing the proportion of breast cancer patients that experience grade 2 or higher RD as measured by the RTOG scoring system

The Effect of RadiaAce Gel in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients

The Effect of RadiaAce Gel Versus Biafine in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients

Skin condition (grade of RD) in the radiation area will be measured by the Radiation Therapy Oncology Group (RTOG) scoring

Dermatitis-related pain is assessed with a visual analogue scale (VAS) self-assessment

The Patients perspective is captured by the Dermatology Life Quality Index (DLQI)

AceTech

Keratosis, Actinic

Keratosis

Precancerous Conditions

Dermatologic Agents

Mineral Oil

Bacitracin

Anti-Infective Agents, Local

Anti-Bacterial Agents

Subjects were randomized to apply Biafine® to wounds on the left forearm and polysporin (standard of care) to wounds on the right forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.

Subjects were randomized to apply Biafine to wounds on the right forearm and Polysporin to wounds on the left forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.

Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance.

over the counter Polysporin ointment 3 times daily for 4 weeks to wounds

Polysporin

Steve Feldman, MD, PhD

The purpose of this research study is to evaluate the use of Biafine Cream on wounds created by removal of actinic keratosis using cryotherapy in a clinical setting.

Subjects were randomized to apply Biafine® to wounds on one forearm and polysporin (standard of care) to wounds on the other. Medications were applied three times a day for 4 weeks to the areas that have been treated with cryotherapy at the baseline visit.

Clinical Trial to Evaluate Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy

A Randomized Right/Left Clinical Trial to Evaluate the Use of Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy

The change in the Mean Severity Score from Baseline to Week 4 (or end of treatment) as measured by the Mean Combined Severity Scores for Erythema, Scab, and Thickness on a scale of 0-4 with 0=None 1=slight 2=mild 3= moderate 4= severe

Wake Forest University

Experimental: Biafine Treatment Group

This group includes the forearm of the subjects that was randomized to apply Biafine® to wounds (either the left forearm or right forearm). Biafine was applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.

Drug: Biafine Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance.

Other Names:

• Biafine

Biafin Treatment Group

Active Comparator: Polysporin Treatment Group

This group includes the forearm of the subjects that was randomized to apply Polysporin (standard of care) to wounds (either the left forearm or right forearm). Polysporin was applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.

Drug: Polysporin over the counter Polysporin ointment 3 times daily for 4 weeks to wounds

Other Names:

• Bacitracin

Polysporin Treatment Group

Subjects were randomized to apply Biafine® to wounds on the left forearm and polysporin (standard of care) to wounds on the right forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.

Biafine: Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance.

Polysporin: over the counter Polysporin ointment 3 times daily for 4 weeks to wounds

Biafin on Left

Subjects were randomized to apply Biafine® to wounds on the right forearm and polysporin (standard of care) to wounds on the left forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.

Biafine: Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance.

Polysporin: over the counter Polysporin ointment 3 times daily for 4 weeks to wounds

Biafin on Right

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Steve Feldman MD

This group includes the forearm of the subjects that was randomized to apply Biafine® to wounds (either the left forearm or right forearm). Biafine was applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.

Drug: Biafine Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance.

Other Names:

• Biafine

Biafine Treatment Group

This group includes the forearm of the subjects that was randomized to apply Polysporin (standard of care) to wounds (either the left forearm or right forearm). Polysporin was applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.

Drug: Polysporin over the counter Polysporin ointment 3 times daily for 4 weeks to wounds

Other Names:

• Bacitracin

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Effect of RadiaAce Gel in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients	NCT04481802	Breast Cancer Radiation Derma...	RadiaAce gel Biafine	18 Years - 120 Years	AceTech
Clinical Trial to Evaluate Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy	NCT00695578	Actinic Keratos...	Biafine Polysporin	50 Years -	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for biafine

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

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