Mechlorethamine Induced Contact Dermatitis Avoidance Study
Condition: Cutaneous T-cell Lymphoma; Cutaneous T-cell Lymphoma Stage I; Mycosis Fungoides; Folliculotropic Mycosis Fungoides; Granulomatous Slack Skin; Syringotropic Mycosis Fungoides; Mycosis Fungoides Variant; Transformed Mycosis Fungoides
MeSH terms: Mycoses; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Mycosis Fungoides; Lymphoma, T-Cell, Cutaneous; Dermatitis; Dermatitis, Contact
Intervention: Triamcinolone; Valchlor 0.016 % Topical Gel
Intervention description: Apply up to three times daily on select lesions.; Apply valchlor nightly on select lesions.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Mechlorethamine; Triamcinolone diacetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: open-label, split-face study
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CTCL; topical mechlorethamine; Valchlor; contact dermatitis; triamcinolone; MF; Cutaneous T-cell Lymphoma

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.
    

Eligibility criteria:

        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.