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Pairing a steroid with lymphoma gel may prevent painful skin reactions
NCT ID NCT03380026
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
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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 Hide 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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