StrataCTX® Gel for Skin Reactions from Cancer Treatment

Recruiting at 1 trial location

Overseen By Larisa J Geskin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must be taking: Topical steroids

Must not be taking: Oral steroids

Disqualifiers: Radiotherapy, Unable to apply topicals, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if StrataCTX® gel, a flexible wound dressing, can manage skin reactions more effectively than usual steroid creams for individuals undergoing certain cancer treatments. It focuses on those experiencing skin issues from cutaneous T-cell lymphoma (CTCL) or chemotherapy/immunotherapy. The trial seeks participants with CTCL who have skin reactions from treatment, intense itching, or rely on steroid creams for relief. It may also include individuals on chemotherapy or immunotherapy who develop skin rashes requiring steroid creams. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance skin care for cancer patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude those currently receiving oral steroids. It seems you can continue with other medications unless specified otherwise by the trial coordinators.

What prior data suggests that StrataCTX® gel is safe for treating skin reactions?

Research has shown that StrataCTX® gel protects and treats damaged skin, such as rashes and other reactions. As a non-steroidal gel, it avoids the side effects associated with some steroid treatments.

StrataCTX® forms a protective layer on the skin, blocking irritants and germs to aid healing. Although specific trial data on its safety is unavailable, its use for various skin problems suggests it is generally well-tolerated.

Overall, StrataCTX® seems to be a safe option for managing skin reactions from cancer treatments, offering an alternative to steroids without the same side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

StrataCTX® gel is unique because it targets skin reactions from cancer treatments like mechlorethamine gel, commonly used for conditions such as CTCL (cutaneous T-cell lymphoma). While current treatments mainly focus on managing symptoms after they appear, StrataCTX® works proactively by forming a protective film over the skin. This helps prevent and reduce the severity of skin reactions, offering a potential advantage in comfort and quality of life for patients. Researchers are excited about its ability to complement existing therapies, providing a new layer of protection that current options don't offer.

What evidence suggests that StrataCTX® gel might be an effective treatment for skin reactions from cancer treatment?

Research has shown that StrataCTX® gel might help reduce skin reactions in cancer patients undergoing treatment. Studies suggest it can decrease the need for topical steroids, which typically treat these skin issues. In this trial, patients with cutaneous T-cell lymphoma (CTCL) will receive StrataCTX® gel alongside their cancer treatment with mechlorethamine gel. Early findings indicate that these patients experience fewer skin problems, potentially reducing their need for steroids, which often have side effects. Overall, early results are promising for using StrataCTX® to manage skin reactions related to cancer therapies. ^{3 5 6 7 8}

Who Is on the Research Team?

Larisa J Geskin, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Cutaneous T-Cell Lymphoma (CTCL) who use topical steroids for relief or have contact dermatitis from mechlorethamine gel. It's also open to those on chemo/immunotherapy with drug-induced rashes but not to patients on oral steroids or undergoing radiotherapy.

Inclusion Criteria

Ability to sign informed consent document

I use a lot of cream for my cutaneous T-cell lymphoma symptoms.

I have CTCL and suffer from severe itching.

Exclusion Criteria

I am currently taking oral steroids.

I cannot apply creams or ointments by myself.

I am currently receiving radiotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive StrataCTX® gel as a steroid sparing agent for cutaneous reactions

3 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• StrataCTX® gel

Trial Overview The study tests if StrataCTX® gel can replace topical steroids in treating skin reactions from CTCL and cancer treatments. Participants will use the gel instead of their usual steroid creams to see if it's more effective or has fewer side effects.

How Is the Trial Designed?

Group I: CTCL group Experimental Treatment 1 Intervention

Patients with CTCL being treated with mechlorethamine gel will receive StrataCTX® gel.

StrataCTX® gel is already approved in Switzerland, United States, European Union for the following indications:

Approved in Switzerland as StrataCTX for:

• Cutaneous reactions
• Dry skin
• Cutaneous rashes
• Wound care

Approved in United States as StrataCTX for:

• Cutaneous reactions
• Dry skin
• Cutaneous rashes
• Wound care

Approved in European Union as StrataCTX for:

• Cutaneous reactions
• Dry skin
• Cutaneous rashes
• Wound care

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

The MedicelTulle Dressing (MTD) was evaluated in a 28-day study involving 30 patients with chronic or acute wounds, showing good safety with only one treatment-related adverse event reported.

MTD led to a significant mean reduction in wound size of 7.0 cm², indicating its potential effectiveness in promoting healing in wounds left to heal by secondary intention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2 study of a new Hydrofiber dressing for superficial chronic or acute wounds. Faucher, N., Ehrler, S., Vin, F., et al.[2008]

The hydrocellular foam dressing significantly enhanced wound healing in rat excisional wounds by promoting granulation tissue formation and accelerating epithelialization compared to traditional gauze dressings.

Gauze dressings led to scab formation that impaired healing and increased VEGF expression, while the hydrocellular foam dressing facilitated new blood vessel formation, indicating a more effective mechanism for wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A hydrocellular foam dressing versus gauze: effects on the healing of rat excisional wounds. Kunugiza, Y., Tomita, T., Moritomo, H., et al.[2022]

The study investigates the effectiveness of hydrogels and foam dressings in managing bleeding from fungating wounds and hydrostatic leg ulcers, which are common in community leg ulcer clinics.

Combining these two types of dressings may enhance wound care by controlling bleeding more effectively, although specific data on the number of subjects or duration of the study is not provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Letters. Stevens, J., Emflorgo, CA., Bliss, MR., et al.[2019]

The yearly prevalence of Stevens-Johnson syndrome (SJS) in Japan was found to be 2.5 cases per million, while toxic epidermal necrolysis (TEN) had a prevalence of 1 case per million, based on a survey of 1205 institutions from 2016 to 2018.

The mortality rate for TEN was notably high at 29.9%, with high-dose steroid therapy showing the most significant reduction in mortality compared to expected rates, indicating its potential as an effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nationwide epidemiological survey of Stevens-Johnson syndrome and toxic epidermal necrolysis in Japan, 2016-2018. Sunaga, Y., Kurosawa, M., Ochiai, H., et al.[2021]

A total of 745 cases of severe cutaneous adverse reactions (SCARs) were identified in South Korea, with allopurinol, carbamazepine, vancomycin, and antituberculous agents being the most common culprits.

The overall mortality rate for SCARs was 6.6%, with a significant number of deaths occurring within 60 days of symptom onset, highlighting the serious nature of these reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Nationwide Study of Severe Cutaneous Adverse Reactions Based on the Multicenter Registry in Korea. Kang, DY., Yun, J., Lee, SY., et al.[2021]

A 3-month-old infant with toxic epidermal necrolysis showed complete recovery after receiving treatment with Suprathel and fatty gauze as topical wound dressings, alongside standard burn resuscitation protocols.

This case report is significant as it is the first documented use of Suprathel in a baby suffering from toxic epidermal necrolysis, suggesting its potential efficacy in treating severe skin disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Suprathel dressing in a young infant with TEN. Pfurtscheller, K., Zobel, G., Roedl, S., et al.[2013]

In a study of 209 patients with severe cutaneous adverse drug reactions (SCAR), antibiotics were the most common causative drugs, accounting for 35.9% of cases, highlighting the need for careful monitoring when prescribing these medications.

Independent risk factors for worse outcomes included a high Registry of Severe Cutaneous Adverse Reactions score and low hemoglobin levels for DRESS, while anemia and the extent of body surface area affected were significant for SJS/TEN, indicating that these factors can guide clinical management and prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical features and prognostic factors of severe cutaneous adverse drug reactions: A single-center retrospective study of 209 cases in China. Deng, M., Su, Y., Wu, R., et al.[2023]

The flexible film-forming wound dressing Stratamed® was found to be safe and effective in promoting faster healing and epithelialization of open wounds, as demonstrated in a series of case studies.

This dressing not only accelerated wound healing but also helped prevent abnormal scarring across various dermatologic surgical procedures, leading to positive patient feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an Innovative Film-Forming Wound Dressing on Open Wounds. Raventós, XC., Flores Climente, VA., García Navarro, X., et al.[2020]

In a study of 88 patients with severe cutaneous adverse reactions (SCARs), SJS/TEN had a mortality rate of 9.8%, while DRESS had a lower rate of 2.1%, indicating a significant difference in severity between these conditions.

Thrombocytopenia was associated with prolonged hospitalization in SJS/TEN patients, while leukocytosis at presentation was linked to longer stays in DRESS patients, suggesting these could be useful prognostic markers for managing SCARs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical features and prognostic factors in severe cutaneous drug reactions. Yang, MS., Kang, MG., Jung, JW., et al.[2013]

StrataXRT, a topical gel dressing, significantly reduces the risk of developing severe acute radiation dermatitis (grade 3) in breast cancer patients undergoing radiotherapy, with an odds ratio of 0.05 based on three randomized controlled trials involving 189 patients.

The use of StrataXRT did not present any additional safety concerns, suggesting it is a safe option for patients, although further large-scale studies are needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

StrataXRT for the prevention of acute radiation dermatitis in breast cancer: a systematic review and meta-analysis of randomized controlled trials. Lee, SF., Shariati, S., Caini, S., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04087629

NCT04087629 | StrataCTX® as a Steroid Sparing Device The primary objective of this study is to determine whether StrataCTX® gel is effective as a supportive therapy for cutaneous reactions treated with topical ...

2. withpower.com withpower.com/trial/phase-6-2021-023b0

StrataCTX® Gel for Skin Reactions from Cancer Treatment This trial is testing StrataCTX® to see if it can reduce the need for steroids in treating skin reactions in people with certain cancers.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-03473

StrataCTX for Use as a Steroid Sparing Agent in Patients ... This trial studies how well StrataCTX works as a steroid sparing agent for patients with skin (cutaneous) reactions related to acute graft versus host ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04087629/stratactxr-as-a-steroid-sparing-device

StrataCTX® as a Steroid Sparing Device Contact dermatitis is observed in 56% of patients with cutaneous T-cell lymphoma (CTCL) being treated with topical mechlorethamine gel. This ...

5. cancer.columbia.edu cancer.columbia.edu/cancer-types-care/clinical-trials/find-clinical-trial/post-marketing-surveillance-stratactx-r-flexible-wound-dressing-use-steroid-sparing-agent

Post-marketing surveillance of StrataCTX® flexible wound ... To assess the use of StrataCTX® as a steroid sparing agent for disorders usually treated with topical steroids.

6. stratactx.com stratactx.com/wp-content/uploads/2020/10/StrataCTX-Detail-Aid-Master-Language-English-CT-ML-007-2-0619-4.pdf

Dry Skin Cutaneous Rashes - StrataCTX StrataCTX dries to form a layer which protects compromised skin areas and superficial wounds from irritants and microbial invasion.

7. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=e5f966d7-71d1-4324-ab02-3c841bd702f5

StrataCTX StrataCTX is indicated for use on all types of wounds, toxic and compromised skin including: Cutaneous reactions. Pruritic, itchy skin.

8. stratactx.com stratactx.com/wp-content/uploads/2021/07/StrataCTX_Detail_Aid_Australia_English_A4_CT-AU-007-1-0621.pdf

StrataCTX - A non-steroidal gel for the management of dry ... The therapies may cause a wide range of cutaneous reactions, including the damage of the fast growing skin and nail cells. This.