A Phase 2 interventional study of Triamcinolone and Valchlor 0.016 % Topical Gel in Cutaneous T-cell Lymphoma, Cutaneous T-cell Lymphoma Stage I and Mycosis Fungoides, sponsored by Rochester Skin Lymphoma Medical Group, PLLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Rochester Skin Lymphoma Medical Group, PLLC · Phase 2, Interventional, and Supportive care
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.
Exclusion Criteria:
0.016% w/w topical mechlorethamine gel applied over a minimum of 8 cm2, nightly, over a period of 4 months.
Drug: 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.
Drug: Triamcinolone · Drug: Valchlor 0.016 % Topical Gel
Apply up to three times daily on select lesions.
Also known as: triamcinolone acetonide, Triamcinolone 0.1% ointment
Apply valchlor nightly on select lesions.
Also known as: topical nitrogen mustard, mechlorethamine hydrochloride, mechlorethamine gel
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. A total of 26 participants had evaluable SCORD data available at 4 months for both treatment sides and were included in this analysis. While 28 participants enrolled and 27 had at least one post-baseline assessment, 2 participants withdrew prior to completing the 4-month SCORD evaluation, leaving 26 evaluable subjects.
Time frame: 4 months
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 were evaluated at Screening, Month 1, month 2, month 3, and month 4 visits for incidence of dermatitis. 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. For patch testing, a 1-3+ reaction at the 96hr reading post-application was considered positive for allergic contact dermatitis.
Time frame: Subjects were evaluated for dermatitis at each visit over the 4-month duration of the trial. Monthly study visits at Months 1, 2, 3, and 4. 27 participants had at least one post-baseline measurement and were included in the overall study assessment.
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.
Time frame: 4 months
Efficacy of Valchlor vs Valchlor Plus Triamcinolone
CAILS (Composite Assessment of Index Lesion Severity) is calculated per target lesion. Each component (erythema, scaling, plaque elevation, hypo/hyperpigmentation, and surface area) is graded on a scale of 0 to 8. Total CAILS scores range from 0 to 24 per lesion, where a score of 0 represents complete clearing (best outcome) and 24 represents maximum severe disease (worst outcome).
Time frame: Baseline and Month 4
Patients presenting to medical clinic eligible for mechlorethamine topical therapy.
| Milestone | All Participants |
|---|---|
| Started | 28 |
| Half of body assigned to treatment with valchlor only | 28 |
| Half of body assigned to treatment with valchlor and triamcinolone acetonide | 28 |
| Completed | 25 |
| Not completed | 3 |
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. A total of 26 participants had evaluable SCORD data available at 4 months for both treatment sides and were included in this analysis. While 28 participants enrolled and 27 had at least one post-baseline assessment, 2 participants withdrew prior to completing the 4-month SCORD evaluation, leaving 26 evaluable subjects.
| patients | Valchlor 0.016% Topical Gel | Valchlor Plus Triamcinolone |
|---|---|---|
| Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring | 16 | 11 |
The presence of allergic versus irritant dermatitis was characterized through skin biopsies sent for pathological review and patch testing. Subjects were evaluated at Screening, Month 1, month 2, month 3, and month 4 visits for incidence of dermatitis. 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. For patch testing, a 1-3+ reaction at the 96hr reading post-application was considered positive for allergic contact dermatitis.
| Incidents of dermatitis | All Participants |
|---|---|
| Incidents of Contact Dermatitis | 2 |
| Incidents of Allergic Dermatitis | 10 |
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.
| score on a scale | Valchlor 0.016% Topical Gel | Valchlor Plus Triamcinolone |
|---|---|---|
| Severity of Dermatitis | 24.8 ± 21.8 | 12.7 ± 13.5 |
CAILS (Composite Assessment of Index Lesion Severity) is calculated per target lesion. Each component (erythema, scaling, plaque elevation, hypo/hyperpigmentation, and surface area) is graded on a scale of 0 to 8. Total CAILS scores range from 0 to 24 per lesion, where a score of 0 represents complete clearing (best outcome) and 24 represents maximum severe disease (worst outcome).
| CAILS score | Valchlor 0.016% Topical Gel | Valchlor Plus Triamcinolone |
|---|---|---|
| Average CAILS score at Baseline | 8.6 ± 4.2 | 7.0 ± 5.1 |
| Average CAILS score at Month 4 | 11.4 ± 4.9 | 12.0 ± 4.85 |
Collected over 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Valchlor 0.016% Topical Gel | 0/28 (0%) | 0/28 (0%) | 16/28 (57.1%) |
| Valchlor Plus Triamcinolone | 0/28 (0%) | 0/28 (0%) | 11/28 (39.3%) |
| Event | Valchlor 0.016% Topical Gel | Valchlor Plus Triamcinolone |
|---|---|---|
| Contact DermatitisSkin and subcutaneous tissue disorders | 16/28 | 11/28 |
| Age, Customized(Participants) | All Participants |
|---|---|
| 21-30 | 2 |
| 31-40 | 1 |
| 41-50 | 2 |
| 51-60 | 6 |
| 61-70 | 7 |
| 71-80 | 7 |
| 81-90 | 3 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 10 |
| Male | 18 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 25 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Csr
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