CTCLNCT04087629
StrataCTX® as a Steroid Sparing Device
A study testing StrataCTX® gel in people with CTCL, run by Columbia University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CTCL
- What is being tested?
- StrataCTX® gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2021to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patients with a diagnosis of CTCL who rely heavily on topical steroids for symptomatic relief
- Patients on chemo/immunotherapy with drug induced rash
Who cannot join
- Patients currently undergoing radiotherapy
- Patients currently receiving oral steroids
- Patients who are unable to apply topical medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Larisa Geskin, MD, ljg2145@cumc.columbia.edu
Larisa J Geskin, MD
About this study
Official title: Post-marketing Surveillance of StrataCTX® Flexible Wound Dressing for Use as a Steroid Sparing Agent
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.
Read the detailed description
Topical steroids are the mainstays of treatment for many cutaneous reactions and disorders. Steroids are known to cause many side effects and few effective pharmacologic alternatives exist. Contact dermatitis is observed in 56% of patients with cutaneous T-cell lymphoma (CTCL) being treated with topical mechlorethamine gel. This usually requires chronic treatment with mid-to high-potency steroids. Numerous chemo/immunotherapies are associated with cutaneous reactions including paronychia, hand and foot syndrome, and acneiform rash. Skin toxicity often requires dose reduction of cancer therapies and a variety of skin directed therapies including topical antibiotics and topical steroids. Cutaneous reactions are often the earliest manifestation of acute graft versus host disease. Skin manifestations can be debilitating and treatment usually requires high potency topical steroids. Additional therapies are needed for the treatment of disorders that rely on topical steroids.
- Conditions
- CTCL
- Being tested
- StrataCTX® gel
- Keywords
- CTCL, topical steroids, StrataCTX®, cutaneous, steroid sparing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrataCTX® gelDevice
Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis
| Study group | Role | What they receive |
|---|---|---|
| CTCL group | Experimental | Patients with CTCL being treated with mechlorethamine gel will receive StrataCTX® gel. Receives: Device: StrataCTX® gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Screening through 3 months
Secondary outcomes (3)
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).
Measured: Screening through 3 months
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.
Measured: Screening through 3 months
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.
Measured: Day 30 through 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start7 Jul 2021
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTCLStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larisa Geskin, MD, Columbia University
- Investigators
- Larisa J. Geskin, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087629
- Sponsor's protocol ID
- AAAR6582
- Status last verified
- Sep 2026
- First submitted
- 1 Feb 2019
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Clinical Endpoints/ individual patient data (IPD) will be assessed based on analysis of photos and evaluation of survey data, including scores from Pruritis VAS and Skindex-16 QOL scales. The scores during topical steroid treatment period will be compared to the scores during the StrataCTX® gel treatment period. Safety endpoints will be evaluated based on report of product related adverse events and subsequent study product interruption.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance of StrataCTX® Flexible Wound Dressing for Use as a Steroid Sparing Agent
- ClinicalTrials.gov ID
- NCT04087629
- Acronym / sponsor ID
- AAAR6582
- Conditions
- CTCL
- Keywords
- CTCL, topical steroids, StrataCTX®, cutaneous, steroid sparing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Topical steroids are the mainstays of treatment for many cutaneous reactions and disorders. Steroids are known to cause many side effects and few effective pharmacologic alternatives exist. Contact dermatitis is observed in 56% of patients with cutaneous T-cell lymphoma (CTCL) being treated with topical mechlorethamine gel. This usually requires chronic treatment with mid-to high-potency steroids. Numerous chemo/immunotherapies are associated with cutaneous reactions including paronychia, hand and foot syndrome, and acneiform rash. Skin toxicity often requires dose reduction of cancer therapies and a variety of skin directed therapies including topical antibiotics and topical steroids. Cutaneous reactions are often the earliest manifestation of acute graft versus host disease. Skin manifestations can be debilitating and treatment usually requires high potency topical steroids. Additional therapies are needed for the treatment of disorders that rely on topical steroids.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTCL group | Experimental | Device: StrataCTX® gelPatients with CTCL being treated with mechlorethamine gel will receive StrataCTX® gel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Patients with a diagnosis of CTCL who rely heavily on topical steroids for symptomatic relief
Key exclusion criteria (3 listed)
- Patients currently undergoing radiotherapy
- Patients currently receiving oral steroids
- Patients who are unable to apply topical medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StrataCTX® gelGel forming flexible wound dressing for the prevention and treatment of radiation dermatitis | Device | CTCL group |
Primary outcome
Change in Pruritus Visual Analogue Scale (VAS) Score
Time frame: Screening through 3 months
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).
3 secondary outcomes
Change in SKINDEX-16 Quality of Life (QOL) Score
Time frame: Screening through 3 months
Change in the Rate of Primary Skin Reactions
Time frame: Screening through 3 months
Change in Topical Steroid Use
Time frame: Day 30 through 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- StrataCTX Informational PamphletLink provided by the sponsor.
- StrataCTX FAQSLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Clinical Endpoints/ individual patient data (IPD) will be assessed based on analysis of photos and evaluation of survey data, including scores from Pruritis VAS and Skindex-16 QOL scales. The scores during topical steroid treatment period will be compared to the scores during the StrataCTX® gel treatment period. Safety endpoints will be evaluated based on report of product related adverse events and subsequent study product interruption.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Larisa J. Geskin, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StrataCTX® gel in people with CTCL, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Larisa Geskin, MD (212-305-5293, ljg2145@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pruritus Visual Analogue Scale (VAS) Score (time frame: Screening through 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.