Mechlorethamine Induced Contact Dermatitis Avoidance Study
United States28 participantsStarted 2017-12-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 d…
What they're measuring
1
Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring
Timeframe: 4 months
Trial details
NCT IDNCT03380026
SponsorRochester Skin Lymphoma Medical Group, PLLC