Randomized Mechlorethamine/Chlormethine Induced Dermatitis Assessment Study (MIDAS) Establishes Benefit of Topical Triamcinolone 0.1% Ointment Cotreatment in Mycosis Fungoides

Carolina V Alexander-Savino, Catherine G Chung, Elaine S Gilmore, Sean M Carroll, Brian Poligone, Carolina V Alexander-Savino, Catherine G Chung, Elaine S Gilmore, Sean M Carroll, Brian Poligone

Abstract

Introduction: Treatment of early-stage mycosis fungoides (MF) requires safe, skin-directed therapies. Medication side effects can lead to underutilization of effective therapies. The objective of this study was to assess the use of topical triamcinolone 0.1% ointment as a means of reducing contact dermatitis associated with topical mechlorethamine/chlormethine gel for the treatment of MF.

Methods: This prospective, randomized, open-label study evaluated 28 adults with mycosis fungoides who were eligible for treatment with topical mechlorethamine/chlormethine gel from December 17, 2017 to December 23, 2020. Patients were treated for 4 months with clinical follow-up through 12 months. Patients had half of their lesions also treated with topical triamcinolone 0.1% ointment (while the other half were treated with mechlorethamine/chlormethine alone). The study was self-controlled with separate lesions in the same patient receiving each treatment arm. Treatment arms were determined by the flip of a coin.

Results: Twenty-eight patients enrolled (17 men (61%) and 11 women (39%)). Demographics included 25 White, 2 African Americans, and 1 Asian patient. Twenty-five completed the 12-month follow-up. Triamcinolone 0.1% ointment led to increased tolerability of mechlorethamine/chlormethine gel but did not change the efficacy of mechlorethamine/chlormethine. There was a statistically significant 50% decrease in dermatitis (SCORD score) at month 2 in the triamcinolone-treated arm.

Conclusions: Topical triamcinolone ointment is a helpful adjuvant therapy when treating patients with topical mechlorethamine/chlormethine gel. It diminishes inflammation and does not reduce efficacy. The peak incidence of dermatitis in the study occurred in the second and third months.

Trial registration: ClinicalTrials.gov identifier, NCT03380026.

Keywords: Contact dermatitis; Drug reactions; Lymphoma; MF; Patch testing; Prescription drug management; Therapeutics.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
A Description of SCORD scoring. B Timing of contact dermatitis reactions measured with SCORD in patients treated with mechlorethamine/chlormethine gel only and clinically presenting with “none to mild dermatitis” versus “moderate to severe dermatitis”
Fig. 2
Fig. 2
A Mechlorethamine (MCN) gel monotherapy shows increased dermatitis as measured by the SCORD score. The ratio of tSCORD (triamcinolone (TAC) plus MCN gel therapy) compared to vSCORD (MCN gel monotherapy) shows that dermatitis is decreased in all months of study treatment. B At the peak level of dermatitis, in month 3, addition of TAC significantly decreases dermatitis
Fig. 3
Fig. 3
Mechlorethamine induced contact dermatitis (patient 21 and 23): acute spongiosis with papillary dermal edema. Brisk superficial and deep perivascular infiltrates with eosinophils
Fig. 4
Fig. 4
Addition of triamcinolone (TAC) 0.01% ointment to mechlorethamine (MCN) gel therapy does not affect efficacy. A Treatment with MCN gel alone (CAILS VAL) versus MCN gel and TAC ointment (CAILS TAC) result in similar composite assessment (CAILS) scores. B Three T cell clones in the skin identified at baseline are treated with MCN gel alone (Valchlor) or combined treatment with MCN and TAC (Valchlor.TAC) are significantly diminished at month 5

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Source: PubMed

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