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| Name | Class |
|---|---|
| Rochester General Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valchlor 0.016% Topical Gel | Experimental | 0.016% w/w topical mechlorethamine gel applied over a minimum of 8 cm2, nightly, over a period of 4 months. |
|
| Valchlor plus Triamcinolone | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone | Drug | Apply up to three times daily on select lesions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring | 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. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Nature of Contact Dermatitis (Allergic Versus Irritant) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Dermatitis | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Poligone, MD, PhD | Rochester Skin Lymphoma Medical Group, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rochester Skin Lymphoma Medical Group, PLLC | Fairport | New York | 14450 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23069814 | Background | Lessin SR, Duvic M, Guitart J, Pandya AG, Strober BE, Olsen EA, Hull CM, Knobler EH, Rook AH, Kim EJ, Naylor MF, Adelson DM, Kimball AB, Wood GS, Sundram U, Wu H, Kim YH. Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides. JAMA Dermatol. 2013 Jan;149(1):25-32. doi: 10.1001/2013.jamadermatol.541. | |
| 35122614 |
| Label | URL |
|---|---|
| Valchlor package insert | View source |
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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.
Expected embargo would be one year from study completion. De-identified data will be maintained at the study site for 2 years after the study ends. Contact addresses and phone numbers will be presented on all publications to assist in this study sharing.
Data will be shared with investigators whose proposed use of data has been approved by an independent institutional review board.
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Two week wash out. Prior to treatment, one half of each patient's body (divided sagittally at the midline) is assigned to treatment with Valchlor only, while the other side of the patient's body is assigned to treatment with both Valchlor and Triamcinolone Acetonide. Group assignment is determined randomly by the flip of a coin.
Patients presenting to medical clinic eligible for mechlorethamine topical therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2017 |
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open-label, split-face study
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| Valchlor 0.016 % Topical Gel | Drug | Apply valchlor nightly on select lesions. |
|
|
| 4 months |
| 4 months |
| Efficacy of Valchlor vs Valchlor Plus Triamcinolone | 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. | 4 months |
| Derived |
| Alexander-Savino CV, Chung CG, Gilmore ES, Carroll SM, Poligone B. Randomized Mechlorethamine/Chlormethine Induced Dermatitis Assessment Study (MIDAS) Establishes Benefit of Topical Triamcinolone 0.1% Ointment Cotreatment in Mycosis Fungoides. Dermatol Ther (Heidelb). 2022 Mar;12(3):643-654. doi: 10.1007/s13555-022-00681-6. Epub 2022 Feb 5. |
| Triamcinolone acetonide information | View source |
| Half of Body Assigned to Treatment With Valchlor Only | Side of body from each patient assigned to treatment with Valchlor only, assigned randomly at enrollment. |
|
| Half of Body Assigned to Treatment With Valchlor and Triamcinolone Acetonide | Side of body from each patient assigned to treatment with both Valchlor and Triamcinolone, assigned randomly at enrollment. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring | 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. | Each patient had both treatments (self-controlled) | Posted | Number | patients | 4 months |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Nature of Contact Dermatitis (Allergic Versus Irritant) | 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. | 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. | Posted | Count of Units | Incidents of dermatitis | 4 months | Incidents of dermatitis | Incidents of dermatitis |
| |||||||||||||||||||||||||||||
| Other Pre-specified | Severity of Dermatitis | 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. | Posted | Mean | Standard Deviation | score on a scale | 4 months |
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Efficacy of Valchlor vs Valchlor Plus Triamcinolone | 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. | CAILS | Posted | Mean | Standard Deviation | CAILS score | 4 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Valchlor 0.016% Topical Gel | 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. | 0 | 28 | 0 | 28 | 16 | 28 |
| EG001 | Valchlor Plus Triamcinolone | 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. | 0 | 28 | 0 | 28 | 11 | 28 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contact Dermatitis | Skin and subcutaneous tissue disorders | NCI CTCAE Version v4 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | Rochester Skin Lymphoma Medical Group | (585)364-1188 | scarroll@roclymphoma.com |
| Jul 30, 2021 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D003877 | Dermatitis, Contact |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D014222 | Triamcinolone Acetonide |
| D009824 | Ointments |
| D000588 | Amines |
| D005782 | Gels |
| D008466 | Mechlorethamine |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D009930 | Organic Chemicals |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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| Title | Measurements |
|---|
|
| 51-60 |
|
| 61-70 |
|
| 71-80 |
|
| 81-90 |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
| Incidents of dermatitis |
|
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|
|
|
|