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Mechlorethamine Induced Contact Dermatitis Avoidance Study

NCT03380026 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-11-24

Study results available
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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.

Conditions

  • 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

Interventions

DRUG

Triamcinolone

Apply up to three times daily on select lesions.

DRUG

Valchlor 0.016 % Topical Gel

Apply valchlor nightly on select lesions.

Sponsors & Collaborators

  • Rochester General Hospital

    collaborator OTHER

  • Rochester Skin Lymphoma Medical Group, PLLC

    lead OTHER

Principal Investigators

  • Brian Poligone, MD, PhD · Rochester Skin Lymphoma Medical Group, PLLC

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-13
Primary Completion
2020-08-03
Completion
2020-12-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03380026 on ClinicalTrials.gov