Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Anti-Inflammatory Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Anti-Infective Agents

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Clindamycin

Clindamycin palmitate

Clindamycin phosphate

Glucocorticoids

Hormones

Hormone Antagonists

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

Anti-Bacterial Agents

Patients who are scheduled to receive TTFields therapy for newly diagnosed GBM will be treated with: topical clindamycin (or approved equivalent) 1% and triamcinolone 0.1%. Participating sites may use an alternative equivalent form of clindamycin, such as a gel, with MSK PI approval

phosphate 1% solution triamcinolone 0.01% at every array change (or approved equivalent)

Clindamycin Phosphate

triamcinolone acetonide 0.01% lotion triamcinolone 0.01% at every array change

Alina Markova, MD

Rashek Kazi, MD,PhD

Priya Kumthekar, MD

Deric M Park, MD, FACP

Rashek Kazi, MD, PhD

The participants are being treated with Tumor Treating Fields (TTFields) for malignant glioma, and this type of treatment may cause skin-related side effects. This study will test whether using clindamycin and triamcinolone topical lotions can prevent skin-related side effects of TTFields.

This is a phase 2, multicenter, open-label study.

Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields

The PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy With Clindamycin and Triamcinolone in Glioblastoma Patients Treated With Tumor Treating Fields

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.

device-related skin adverse events by investigator assessment.

using the PRO-CTCAE for rash, ulcer, and pruritus.

Memorial Sloan Kettering Cancer Center

Digestive System Diseases

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Pancreatic Neoplasms

Pancreatitis

Pancreatitis, Chronic

Celiac Disease

Gastrointestinal Diseases

Pancreatic Diseases

Chronic Disease

Disease Attributes

Pancreatic Cancer

Chronic Graft Versus Host Disease

Central Nervous System Depressants

Ethanol

Anti-Infective Agents, Local

subjects who are getting a celiac block for chronic pancreatitis

subjects who are getting a celiac block for pancreatic cancer

80mg of triamcinolone injected into the celiac ganglion during the EUS-CB

triamcinolone

10ml of 98% dehydrated alcohol injected into the celiac ganglion during the EUS-CB

98% dehydrated alcohol

Julia LeBlanc, MD, MPH

The purpose of this prospective study is to measure the clinical effectiveness of EUS-guided CB in subjects, 50 who have chronic pancreatitis and 50 who have pancreatic cancer, that are already undergoing celiac block for clinical reasons.

A Prospective Study of EUS Guided Celiac Block

A Prospective Study of Endoscopic Ultrasound-guided Celiac (CB) Effectiveness

Indiana University

Mouth and Tooth Diseases

Fibrosis

Oral Submucous Fibrosis

Mouth Diseases

Stomatognathic Diseases

Anti-Arrhythmia Agents

Channel Blockers

Vasodilator Agents

Platelet Aggregation Inhibitors

Micronutrients

Vitamins

Lidocaine

Pentoxifylline

Tocopherols

Vitamin E

Tocotrienols

alpha-Tocopherol

Trace Elements

Antioxidants

Protective Agents

Phosphodiesterase Inhibitors

Radiation-Protective Agents

Tocopherol

Tocotrienol

Injection steroid Triamcinolone 400mg with lidocaine 1:1 was given twice a week for 4 weeks in bi-lateral buccal mucosa in multiple sites

Pentoxifylline 40mg twice a day along with vitamin E supplement one tablet per day for 4 weeks

Comparison of Triamcinolone with Pentoxifylline and Vitamin- E Efficacy

Pentoxifylline with Vitamin E

To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis.

To compare the efficacy of Triamcinolone with Pentoxifylline and Vitamin E in patients with stage two and three oral submucous fibrosis.

It was a randomized control clinical trial to compare efficacy of injection steroids versus pentoxifylline and vitamin E in the treatment of stage 2 and 3 OSF patient. Total 40 patients who presented with signs and symptoms of OSF were enrolled in our study that was evaluated over the period of (January 2020 to September 2021). Parameters taken in the study were age and mouth opening. Descriptive statistics and paired t-test were used for statistical analysis.

Group 1: Triamcinolone Group 2: Pentoxifylline

Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis

Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis: A Clinical Trial

Measuring mouth opening measuring mouth opening using calibrated Vernier Caliper by recording in millimeters the maximum mouth opening

Altamash Institute of Dental Medicine

Dr. Abhishek Lal

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Immune System Diseases

Infections

Dermatitis

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Mycoses

Mycosis Fungoides

Dermatitis, Contact

Lymphoma, T-Cell, Cutaneous

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Skin Diseases

Lymphoma, Non-Hodgkin

Communicable Diseases

Bacterial Infections

Bacterial Infections and Mycoses

Skin Diseases, Eczematous

Lymphosarcoma

Peripheral T-cell Lymphoma

Cutaneous T-cell Lymphoma

Granulomatous Slack Skin Disease

Antineoplastic Agents

Mechlorethamine

Nitrogen Mustard Compounds

Alkylating Agents

Antineoplastic Agents, Alkylating

0.016% w/w topical mechlorethamine gel applied over a minimum of 8 cm2, nightly, over a period of 4 months.

0.016% w/w topical mechlorethamine gel (once, nightly) and Triamcinolone acetonide 0.1% ointment (up to three times daily) applied in over a minimum of 8 cm2, over a period of 4 months.

Apply up to three times daily on select lesions.

Apply valchlor nightly on select lesions.

Valchlor 0.016 % Topical Gel

Brian Poligone, MD, PhD

This is a two-arm, open-label study that aims to compare the incidence and severity of the most common adverse reactions, particularly contact dermatitis, when Valchlor is used alone or in conjunction with triamcinolone ointment 0.1% in early stage MF subjects (Stage IA and IB) for a period of 4 months.

Mechlorethamine hydrochloride, or most commonly known as nitrogen nitrogen mustard, was approved by the FDA in 2013 for the treatment of IA and IB Mycosis Fungoides. The most common side effect of Valchlor is a skin rash, which is routinely ameliorated with the application of topical corticosteroids, such as topical Triamcinolone. The main purpose of this study is to determine the efficacy of Triamcinolone in reducing side effects cause by Valchlor and further understand the nature of this skin rash.

This is a split-face study, meaning that subjects will receive both therapies, but limit use to designated areas. Treatment lasts 4 months with follow ups at 5 and 12 months.

Mechlorethamine Induced Contact Dermatitis Avoidance Study

Valchlor Therapy in Conjunction With Triamcinolone 0.1% Ointment for the Treatment of Contact Dermatitis in Patients With Early Stage Cutaneous T-cell Lymphoma (Mechlorethamine Induced Dermatitis Avoidance Study)

Data will be embargoed until the study site has fully examined it. Expected embargo would be one year from study completion.

Study data that is de-identified will be maintained at the study site. As this field is rapidly changing, if a database is available for safe, public upload at the end of study embargo, it will be uploaded to a national database. Otherwise requests for use of the study data will be accepted at the study site and shared with investigators whose proposed use of data has been approved by an independent institutional review board. Contact addresses and phone numbers will be presented on all publications to assist in this study sharing.

Scoring Atopic Dermatitis (SCORAD) differences between lesions treated with Valchlor and Triamcinolone versus lesions treated with Valchlor only. SCORAD measures the extent and severity of dermatitis. The percentage of total body surface area (0-100) covered by a lesion is measured by an investigator, and this number corresponds to score "A." The intensity criteria are met by scoring erythema, edema/papulation, oozing/crusting, excoriation, xerosis, and thickness on a scale of 0-3 (0=none, 1=mild, 2=Moderate, 3=Severe). These values are summed to give a total score, "B." Subjective symptoms of pruritus and insomnia are then scored using visual analogue scales ranging from 0-10 (0=none, 10=worst imaginable), and the result of each is summed to give score "C". The final score is then calculated by the formula A/5 + 7B/2 + C. The lowest possible score is 0, and the highest possible score is 103. A higher score indicates a worse outcome.

A lower score would be a better outcome.

Efficacy of Valchlor therapy with Triamcinolone compared to Valchlor using a composite assessment of index lesion severity (CAILS). CAILS is an objective, quantitative, method to assess the extent of skin lesions. Skin lesions and erythema will be evaluated using CAILS. A Composite Assessment will be generated for each time point by a summation of the grades for each index lesion's erythema, scaling, plaque elevation, hypopigmentation or hyperpigmentation, and area of involvement. The index lesion grade at baseline will be divided into the grade at each subsequent study visit to determine the subject's response to treatment. Any ratio of the grade obtained at the visit vs. the one obtained at baseline that is \>1.0 will indicate worsening of disease.

Incidence of moderate to severe contact dermatitis in patients treated concurrently with Triamcinolone 0.1% ointment versus those that are not. Dermatitis will be defined as a finding of cutaneous inflammatory reaction occurring as a result of treatment. This will be assessed by the SCORD (SCORing Dermatitis) tool and may be confirmed by biopsy of the specimen. Moderate to Severe Contact dermatitis is defined as \>25 by SCORD.

The presence of allergic versus irritant dermatitis was characterized through skin biopsies sent for pathological review and patch testing. Subjects presenting to the clinic with dermatitis underwent patch testing to determine the presence of allergic vs. Irritant contact dermatitis, and at each case a biopsy sample was taken of the affected area to confirm the diagnosis. Patch testing was assessed by the investigator according to the International Contact Dermatitis Research Group scale, using the following for possible outcomes : ?+ indicates a doubtful reaction, 1+ indicates a weak reaction, 2+ represents a strong reaction, 3+ indicates an extreme reaction, and IR indicates an Irritant reaction. A higher score would indicate a worse outcome. 1-3+ reaction at the 96hr reading was considered positive for allergic contact dermatitis.

Rochester General Hospital

Rochester Skin Lymphoma Medical Group, PLLC

0.016% w/w topical mechlorethamine gel applied over a minimum of 8 cm2, nightly, over a period of 4 months.

Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions.

Valchlor 0.016% Topical Gel

0.016% w/w topical mechlorethamine gel (once, nightly) and Triamcinolone acetonide 0.1% ointment (up to three times daily) applied in over a minimum of 8 cm2, over a period of 4 months.

Triamcinolone: Apply up to three times daily on select lesions.

Valchlor 0.016 % Topical Gel: Apply valchlor nightly on select lesions.

Valchlor Plus Triamcinolone

Group consisting of all trial participants that completed screening and randomization.

In this split-person study, lesions from one half of each participant's body are assigned to one of two treatment groups: One half of the body is assigned to treatment of affected lesions with Valchlor only, while the other half of the body is assigned to treatment of affected lesions with both Valchlor and Triamcinolone.

For the Valchlor only group, Valchlor is applied once nightly to the target lesions.

For the Valchlor + Triamcinolone group, 0.016% w/w topical mechlorethamine gel is applied once nightly to target lesions, and Triamcinolone acetonide 0.1% ointment is applied up to three time per day to target lesions over a minimum of 8 cm2

For both groups, the treatment period spanned four months.

All Participants

21-30

31-40

41-50

51-60

61-70

71-80

81-90

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

Clinical Research Coordinator

Each patient had both treatments (self-controlled)

Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring

Group of all analyzed study participants. Both irritant and allergic contact dermatitis was observed

All analyzed trial participants Were included in assessment of dermatitis. 12 incidents of dermatitis were observed across the study, and at each incident a biopsy of the affected area was sent for histopathological review. 10 of 12 patients presented with allergic contact dermatitis, while 2 out of 10 12 patients presented with irritant contact dermatitis according to pathology results.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields	NCT04469075	Glioblastoma Recurrent Gliob... Skin Toxicity	Clindamycin Pho... Triamcinolone A...	18 Years -	Memorial Sloan Kettering Cancer Center
A Prospective Study of EUS Guided Celiac Block	NCT00583271	Chronic Pancrea... Pancreatic Canc...	triamcinolone 98% dehydrated ...	18 Years -	Indiana University
Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis	NCT05660694	Triamcinolone Pentoxifylline Vitamin E Oral Submucosa ... Tumor	Triamcinolone Pentoxifylline ...	-	Altamash Institute of Dental Medicine
Mechlorethamine Induced Contact Dermatitis Avoidance Study	NCT03380026	Cutaneous T-cel... Cutaneous T-cel... Mycosis Fungoid... Folliculotropic... Granulomatous S... Syringotropic M... Mycosis Fungoid... Transformed Myc...	Triamcinolone Valchlor 0.016 ...	18 Years -	Rochester Skin Lymphoma Medical Group, PLLC
Comparison of Triamcinolone With Pentoxifylline and Vitamin- E Efficacy in the Treatment of Stage 2 and 3 Oral Submucous Fibrosis	NCT05660694	Triamcinolone Pentoxifylline Vitamin E Oral Submucosa ... Tumor	Triamcinolone Pentoxifylline ...	-	Altamash Institute of Dental Medicine
Sub-Tenon Triamcinolone in the Prevention of Radiation-Induced Macular Edema	NCT00441662	Melanoma	Sub-Tenon triam...	18 Years -	Wills Eye

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