Phase 2
N=28
Mechlorethamine Induced Contact Dermatitis Avoidance Study
Cutaneous T-cell Lymphoma · Cutaneous T-cell Lymphoma Stage I · Mycosis Fungoides · Folliculotropic Mycosis Fungoides · Granulomatous Slack Skin
Bottom Line
View on ClinicalTrials.gov: NCT03380026 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring — 16; 11 patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Triamcinolone (Drug); Valchlor 0.016 % Topical Gel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rochester Skin Lymphoma Medical Group, PLLC
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Moderate to Severe Contact Dermatitis by SCORD Scoring |
16; 11 | — |
| SECONDARY Nature of Contact Dermatitis (Allergic Versus Irritant) |
2; 10 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03380026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.