Pairing a steroid with lymphoma gel may prevent painful skin reactions

NCT ID NCT03380026

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 ยท Last updated Sep 04, 2026

Summary

This phase 2 trial tests whether adding triamcinolone 0.1% ointment to Valchlor gel reduces contact dermatitis, a common skin reaction, in people with early-stage cutaneous T-cell lymphoma. Participants apply Valchlor nightly, with or without the steroid up to three times daily, for four months. Researchers compare the incidence and severity of dermatitis between the two groups using a scoring tool. The goal is to see if the combination makes treatment more tolerable without compromising its effect.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Valchlor (mechlorethamine) gel used alone or with triamcinolone 0.1% ointment
What this could lead to
If adding triamcinolone reduces skin irritation, more people might stick with Valchlor therapy, potentially improving lymphoma control.
What could go wrong
This is a small phase 2 trial with 28 participants, so results may not apply broadly. Adding a steroid could also mask or alter skin reactions, complicating treatment monitoring.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

28 people

The number who actually took part.

Started

Dec 2017

Finished

Dec 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Rochester Skin Lymphoma Medical Group, PLLC

    Fairport, New York, 14450, United States

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