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.
447 studies on the registry are indexed under Mycosis Fungoides; 42 are open to participants now.
This study's enrollment of 28 is below the median of 34 across 321 interventional studies indexed under Mycosis Fungoides.
Browse Mycosis Fungoides studies →This is the only study on the registry with Rochester Skin Lymphoma Medical Group, PLLC as lead sponsor.
Compared within Mycosis Fungoides, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lymphoma, T-Cell, Cutaneous. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug page: Mechlorethamine
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
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: Clinical study report
Time frame: 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.
Access criteria: Data will be shared with investigators whose proposed use of data has been approved by an independent institutional review board.
Ran from Dec 2017 to primary completion in Aug 2020, 31 months.
Results were first posted in Nov 2021, 1 year 3 months after primary completion.
Of 33 non-industry phase 2 interventional studies under Mycosis Fungoides, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 119. This study's 31 months is below that.
Counting every sponsor, half of 42 studies reached it within 64 months; a quarter within 39 and three quarters within 111.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Mechlorethamine