StrataCTX® Gel for Skin Reactions from Cancer Treatment

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Larisa J Geskin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Columbia University

Must be taking: Topical steroids

Must not be taking: Oral steroids

Disqualifiers: Radiotherapy, Unable to apply topicals, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing StrataCTX® to see if it can reduce the need for steroids in treating skin reactions in people with certain cancers. The goal is to find a safer alternative to steroids, which have many side effects. StrataCTX® might help manage these skin issues more effectively. StrataXRT® is a silicone-based gel used for preventing and managing skin problems caused by radiation.

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 data supports the effectiveness of the treatment StrataCTX® Gel for skin reactions from cancer treatment?

Research on a similar gel, StrataXRT, shows it can help prevent skin problems in breast cancer patients receiving radiation. Another study on a related gel, Stratamed, found it helps wounds heal faster and reduces scarring, suggesting StrataCTX might also be effective for skin reactions. ^{1 2 3 4 5}

How is StrataCTX® gel different from other treatments for skin reactions from cancer treatment?

StrataCTX® gel is unique because it acts as a flexible wound dressing, which may provide a protective barrier and promote healing for skin reactions caused by cancer treatments. Unlike some other treatments, it is applied topically (directly on the skin) and is designed to be gentle and non-invasive. ^{6 7 8 9 10}

Research Team

Larisa J Geskin, MD

Principal Investigator

Columbia University

Eligibility Criteria

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 am 18 years old or older.

Exclusion Criteria

I am currently taking oral steroids.

I cannot apply creams or ointments by myself.

I am currently receiving radiotherapy.

Trial Timeline

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

Treatment Details

Interventions

• StrataCTX® gel (Steroid Sparing Device)

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.

Participant Groups

Group I: Skin Toxicity group Experimental Treatment 1 Intervention

Patients with skin toxicity secondary to chemo/immunotherapy will receive StrataCTX® gel.

Group II: 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 for the following indications:

Approved in Switzerland 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+

Dr. Katrina Armstrong

Columbia University

Chief Executive Officer

MD from Johns Hopkins University, MS in Epidemiology from Harvard School of Public Health

Dr. Katrina Armstrong

Columbia University

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

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]

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]

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 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 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]

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]

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 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]

References

1. Germany 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of an Innovative Film-Forming Wound Dressing on Open Wounds. [2020]

3. England pubmed.ncbi.nlm.nih.gov

A hydrocellular foam dressing versus gauze: effects on the healing of rat excisional wounds. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Phase 2 study of a new Hydrofiber dressing for superficial chronic or acute wounds. [2008]

5. England pubmed.ncbi.nlm.nih.gov

Letters. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical features and prognostic factors in severe cutaneous drug reactions. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Use of Suprathel dressing in a young infant with TEN. [2013]

8. Netherlands 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. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The nationwide epidemiological survey of Stevens-Johnson syndrome and toxic epidermal necrolysis in Japan, 2016-2018. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

A Nationwide Study of Severe Cutaneous Adverse Reactions Based on the Multicenter Registry in Korea. [2021]