Skin and Connective Tissue Diseases

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Infections

Symptoms and General Pathology

Rare Diseases

Dermatitis

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Mycoses

Mycosis Fungoides

Dermatitis, Contact

Lymphoma, T-Cell, Cutaneous

Neoplasms by Histologic Type

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

Anti-Inflammatory Agents

All Drugs and Chemicals

Antineoplastic Agents

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Mechlorethamine

Nitrogen Mustard Compounds

Glucocorticoids

Hormones

Hormone Antagonists

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

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.

Spots Global Cancer Trial Database for Mechlorethamine Induced Contact Dermatitis Avoidance Study

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Interventions

Study Description

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