Cutaneous T-cell LymphomaPhase 2MIDASNCT03380026

Mechlorethamine Induced Contact Dermatitis Avoidance Study

A Phase 2 study testing Triamcinolone and Valchlor 0.016 % Topical Gel in people with Cutaneous T-cell Lymphoma and Cutaneous T-cell Lymphoma Stage I, run by Rochester Skin Lymphoma Medical Group, PLLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cutaneous T-cell Lymphoma, Cutaneous T-cell Lymphoma Stage I, Mycosis Fungoides
What is being tested?: Triamcinolone and Valchlor 0.016 % Topical Gel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 13 Dec 2017to 13 Dec 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be eligible to receive Valchlor therapy.
Be at least of 18 years of age and ability to give informed consent
Have stage IA or IB CTCL
Subjects with histologic variants of Mycosis Fungoides such as folliculotropic, granulomatous slack skin, syringotropic MF, or large cell transformation ARE eligible.
A skin biopsy within the last 60 days before start of treatment. In cases with equivocal histological features, the diagnosis may be confirmed with clinicopathologic and/or genetic testing consistent with the National Comprehensive Cancer Network guidelines for Mycosis Fungoides. If sufficient tissue is not available to perform genetic testing, a new biopsy will be performed even if the subject has had a biopsy within 60 days of start of treatment.
Females of child bearing potential must agree to use two highly effective methods of contraception (strongly recommended that one of the two forms of contraception be non-hormonal such as condom plus spermicide, condom plus diaphragm with spermicide, or have a vasectomized partner) or use an intrauterine device until 30 days after the last day of drug administration. Perimenopausal women must be amenorrhoeic for at least 12 months to be considered of nonchildbearing potential.

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Males with female partners of child bearing potential must agree to sexual abstinence or use two reliable forms of effective contraception simultaneously (strongly recommended that one of the two forms should be non-hormonal as described above) during the entire treatment period and 30 days after the last dose.
Must be able to comply with the study instructions, apply the study medication as directed, and attend all visits.
Willingness to avoid sun exposure and ultraviolet B light in areas to be treated.

Who cannot join

Have been treated with topical mechlorethamine within 6 months in lesions followed during this study.
Have received any topical therapy directed against MF within 2 weeks of start of treatment in areas intended to be treated in this study.
Have received any systemic therapy (oral or injectables) within 3 weeks of start of treatment.
Not have any intercurrent illness or infection that would interfere with study participation
Known hypersensitivity to mechlorethamine or triamcinolone.
Breastfeeding, pregnancy, or intention to become pregnant.

Trial locations and contacts

1 site in 1 country.

United States1 site

Rochester Skin Lymphoma Medical Group, PLLC
Fairport, New York, 14450

Other trials in United States

About this study

Official title: 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)

Read the detailed description

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.

Conditions: Cutaneous T-cell Lymphoma, Cutaneous T-cell Lymphoma Stage I, Mycosis Fungoides, Folliculotropic Mycosis Fungoides, Granulomatous Slack Skin, Syringotropic Mycosis Fungoides
Being tested: Triamcinolone, Valchlor 0.016 % Topical Gel
Keywords: CTCL, topical mechlorethamine, Valchlor, contact dermatitis, triamcinolone, MF, Cutaneous T-cell Lymphoma
Medical subject headings: Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Dermatitis, Contact

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TriamcinoloneDrug
Also called triamcinolone acetonide, Triamcinolone 0.1% ointment
Apply up to three times daily on select lesions.
Valchlor 0.016 % Topical GelDrug
Also called topical nitrogen mustard, mechlorethamine hydrochloride, mechlorethamine gel
Apply valchlor nightly on select lesions.

Study groups in NCT03380026
Study group	Role	What they receive
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. Receives: Drug: Valchlor 0.016 % Topical Gel
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. Receives: Drug: Triamcinolone; Drug: Valchlor 0.016 % Topical Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 months

Secondary outcomes (1)

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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Dec 201713 Dec 2020

First posted20 Dec 2017
Study start13 Dec 2017
Primary completion3 Aug 2020
Study completion13 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Cutaneous T-cell LymphomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Single group
Model description: open-label, split-face study
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03380026
Sponsor's protocol ID: RSLMG-17.10
Acronym: MIDAS
Status last verified: Oct 2021
First submitted: 12 Dec 2017
Last updated: 4 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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.

Publications

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.
PubMed 23069814
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.
PubMed 35122614

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT03380026
Acronym / sponsor ID: MIDAS / RSLMG-17.10
Conditions: Cutaneous T-cell Lymphoma, Cutaneous T-cell Lymphoma Stage I, Mycosis Fungoides, Folliculotropic Mycosis Fungoides, Granulomatous Slack Skin, Syringotropic Mycosis Fungoides
Keywords: CTCL, topical mechlorethamine, Valchlor, contact dermatitis, triamcinolone, MF, Cutaneous T-cell Lymphoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Rochester Skin Lymphoma Medical Group, PLLCUniversity, hospital or other
Collaborators: Rochester General Hospital
Study start: 13 Dec 2017 (actual)
Primary completion: 3 Aug 2020 (actual)
Study completion: 13 Dec 2020 (actual)
First posted: 20 Dec 2017 (actual)
Results: Posted 24 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: open-label, split-face study

Arm	Type	Receives
Valchlor 0.016% Topical Gel	Experimental	Drug: Valchlor 0.016 % Topical Gel0.016% w/w topical mechlorethamine gel applied over a minimum of 8 cm2, nightly, over a period of 4 months.
Valchlor plus Triamcinolone	Active comparator	Drug: Triamcinolone, Drug: Valchlor 0.016 % Topical Gel0.016% 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Be eligible to receive Valchlor therapy.
Be at least of 18 years of age and ability to give informed consent
Have stage IA or IB CTCL
Subjects with histologic variants of Mycosis Fungoides such as folliculotropic, granulomatous slack skin, syringotropic MF, or large cell transformation ARE eligible.
A skin biopsy within the last 60 days before start of treatment. In cases with equivocal histological features, the diagnosis may be confirmed with clinicopathologic and/or genetic testing consistent with the National Comprehensive Cancer Network guidelines for Mycosis Fungoides. If sufficient tissue is not available to perform genetic testing, a new biopsy will be performed even if the subject has had a biopsy within 60 days of start of treatment.

Key exclusion criteria (6 listed)

Have been treated with topical mechlorethamine within 6 months in lesions followed during this study.
Have received any topical therapy directed against MF within 2 weeks of start of treatment in areas intended to be treated in this study.
Have received any systemic therapy (oral or injectables) within 3 weeks of start of treatment.
Not have any intercurrent illness or infection that would interfere with study participation
Known hypersensitivity to mechlorethamine or triamcinolone.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TriamcinoloneAlso: triamcinolone acetonide, Triamcinolone 0.1% ointmentApply up to three times daily on select lesions.	Drug	Valchlor plus Triamcinolone
Valchlor 0.016 % Topical GelAlso: topical nitrogen mustard, mechlorethamine hydrochloride, mechlorethamine gelApply valchlor nightly on select lesions.	Drug	Valchlor 0.016% Topical Gel, Valchlor plus Triamcinolone

Primary outcome

Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring
Time frame: 4 months
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.

1 secondary outcome

Nature of Contact Dermatitis (Allergic Versus Irritant)
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.

Results and safety

Results posted to the registry on 24 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	28	25

Primary outcome: Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring

Time frame: 4 months. Number. Unit: patients

Measure	Valchlor 0.016% Topical Gel n = 26	Valchlor Plus Triamcinolone n = 26
Value	16	11

Population analysed: 26 participants were available for analysis due to protocol noncompliance by two subjects. Each patient had both treatments (self-controlled). 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Valchlor 0.016% Topical Gel	0 of 28 (0%)	16 of 28 (57.1%)	0 of 28
Valchlor Plus Triamcinolone	0 of 28 (0%)	11 of 28 (39.3%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23069814Lessin 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.
Derived from this study: PubMed 35122614Alexander-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.
Valchlor package insertLink provided by the sponsor.
Triamcinolone acetonide informationLink provided by the sponsor.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian Poligone, MD, PhD principal investigator

Rochester Skin Lymphoma Medical Group, PLLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03380026, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.