Mechlorethamine Induced Contact Dermatitis Avoidance Study

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.

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.