Trials / Completed
CompletedNCT03380026
Mechlorethamine Induced Contact Dermatitis Avoidance Study
Valchlor Therapy in Conjunction With Triamcinolone 0.1% Ointment for the Treatment of Contact Dermatitis in Patients With Early Stage Cutaneous T-cell Lymphoma (Mechlorethamine Induced Dermatitis Avoidance Study)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Rochester Skin Lymphoma Medical Group, PLLC · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
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
| Type | Name | Description |
|---|---|---|
| DRUG | Triamcinolone | Apply up to three times daily on select lesions. |
| DRUG | Valchlor 0.016 % Topical Gel | Apply valchlor nightly on select lesions. |
Timeline
- Start date
- 2017-12-13
- Primary completion
- 2020-08-03
- Completion
- 2020-12-13
- First posted
- 2017-12-20
- Last updated
- 2021-11-24
- Results posted
- 2021-11-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03380026. Inclusion in this directory is not an endorsement.