StrataCTX® as a Steroid Sparing Device
ConditionCTCL
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
The purpose is to determine if StrataCTX® can be used as a steroid sparing agent for the treatment of cutaneous reactions related to, cutaneous T Cell lymphoma (CTCL) and chemotherapy/immunotherapy treatments than the current standard treatment - topical steroids - in people who are receiving treatment for CTCL, or chemotherapy/immunotherapy for solid/hematologic malignancies. Subjects will have CTCL and are being treated with topical steroids, or being treated with chemotherapy/immunotherapy for another condition and have had cutaneous reactions that have warranted initiation of topical steroids.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Ability to sign informed consent document
Patient with a diagnosis of CTCL who have contact dermatitis to topical mechlorethamine gel
Patients with a diagnosis of CTCL who have intractable pruritis
Disqualifiers
Patients currently undergoing radiotherapy
Patients currently receiving oral steroids
Patients who are unable to apply topical medications
Trial design
Design model
Single group
Treatments tested in this trial
StrataCTX® gel
DeviceGel forming flexible wound dressing for the prevention and treatment of radiation dermatitis
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: CTCL groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Pruritus Visual Analogue Scale (VAS) Score
The primary objective of this study is to determine whether StrataCTX® gel is effective as a supportive therapy for cutaneous reactions treated with topical steroids as the standard of care. This objective will be measured by the Pruritus Visual Analogue Scale, which measures self-reported itching on a scale of 0 (no itching) (better outcome) to 10 (worst imaginable itch).
Time frame
Screening through 3 monthsSecondary outcomes
1
Change in SKINDEX-16 Quality of Life (QOL) Score
Another objective is to determine if StrataCTX® will improve patient quality of life secondary to symptomatic improvement through the use of the Skindex 16 QOL (a dermatologic quality-of-life instrument) , which is a validated measure where participants self-report from 1 (never) - 5 (all the time) how each of 30 statements describes participants feelings related to their skin condition. All responses are transformed to a linear scale of 100, varying from 0 (no effect) (better outcome) to 100 (effect experienced all the time).
Time frame
Screening through 3 months2
Change in the Rate of Primary Skin Reactions
Change in the rate of primary skin reactions in participants between the topical steroid treatment period, compared to the StrataCTX® gel period as evaluated in screening visits.
Time frame
Screening through 3 months3
Change in Topical Steroid Use
Change in topical steroid use during the StrataCTX® gel period as reported daily in patient diaries with time, date, and location of topical steroid application.
Time frame
Day 30 through 3 monthsSponsors and contacts
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Source ClinicalTrials.gov