TriCalm Hydrogel for Itchiness

Overseen By MCC Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Diego

Must be taking: ICIs

Must not be taking: Systemic corticosteroids

Disqualifiers: Primary skin disorders, Open wounds, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new gel, TriCalm Hydrogel, to determine its effectiveness in reducing itchiness caused by immune checkpoint inhibitors (ICIs), medications used in cancer treatment. The study compares the effects of this gel to a common cream, triamcinolone. Suitable participants are those receiving ICIs for cancer treatment and experiencing mild to moderate itchiness, without other skin conditions or open wounds. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in managing cancer treatment side effects.

Will I have to stop taking my current medications?

The trial allows you to continue using oral antihistamines and GABA analogs if you've been taking them for more than 7 days before joining. However, you cannot start any new antipruritic medications or systemic corticosteroids within 7 days before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that TriCalm Hydrogel is generally safe to use. One study found no safety concerns with its application. This gel can be applied frequently for common skin issues like bug bites, without the side effects associated with steroid treatments. It is important to avoid contact with the eyes and not to use it on open cuts. Overall, current research considers the hydrogel safe and effective. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

TriCalm Hydrogel® is unique because it targets itchiness with a gentle, steroid-free formula, unlike many standard treatments that rely on corticosteroids like triamcinolone cream. This makes it an attractive option for those seeking relief without the potential side effects of steroids, such as skin thinning or hormone disruption. Researchers are excited about TriCalm because it can offer a soothing and effective alternative, especially for individuals who need long-term itch management without the risks associated with prolonged steroid use.

What evidence suggests that TriCalm Hydrogel® might be an effective treatment for itchiness related to immune checkpoint inhibitors?

Research has shown that TriCalm Hydrogel® effectively reduces itchiness, decreasing itch intensity by about 30% compared to a regular gel. In some studies, TriCalm proved eight times more effective than a common over-the-counter itch cream with hydrocortisone. Its effectiveness likely stems from strontium, which soothes both allergy-related and non-allergy-related itch. This trial will compare TriCalm Hydrogel® used alone in one arm with Triamcinolone cream followed by TriCalm Hydrogel® in another arm, presenting a promising option for treating itchiness caused by immune therapies. ^{2 4 6 7 8}

Who Is on the Research Team?

Karen M Yun, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for adults 18+ who are receiving immune checkpoint inhibitors (ICIs) for cancer at UC San Diego and have developed mild to moderate itchiness after at least one ICI dose. Those already on antihistamines or GABA analogs can join, but other details about exclusions aren't provided.

Inclusion Criteria

I am getting immune therapy for cancer at Moores Cancer Center.

I developed itching after starting immunotherapy.

I have been taking antihistamines or GABA analogs for over a week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TriCalm Hydrogel® or Triamcinolone cream during cycles 1 and 2 to treat immunotherapy-related pruritus

6-8 weeks

Weekly visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TriCalm Hydrogel®

Trial Overview

The study compares TriCalm Hydrogel®, a strontium-based gel, with Triamcinolone acetonide cream to treat itchiness caused by ICIs in a phase 2 trial. Participants will be randomly assigned to treatments in an open-label setting where both researchers and participants know which treatment is given.

How Is the Trial Designed?

Group I: ARM A Experimental Treatment 1 Intervention

TriCalm Hydrogel® during cycles 1 and 2

Group II: ARM B Active Control 2 Interventions

Triamcinolone cream during cycle 1 followed by Tricalm Hydrogel® during cycle 2

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

A dual-responsive hydrogel drug delivery system was developed using Pluronic F-127 and a polysaccharide-based nano-conjugate, which improved the release properties of gallic acid, a compound used in traditional Chinese medicine for treating atopic dermatitis.

The hydrogel demonstrated good cytotoxicity results, with over 80% cell viability in human keratinocytes at concentrations up to 20 μg/ml, indicating its potential safety for therapeutic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug delivery system of dual-responsive PF127 hydrogel with polysaccharide-based nano-conjugate for textile-based transdermal therapy. Chatterjee, S., Hui, PC., Wat, E., et al.[2021]

In a study involving 18 male Sprague-Dawley rats, wound dressings made from carboxymethylchitosan hydrogel (CM) and chitin-(polyacrylic acid) hydrogel (PAA) showed no signs of dermal irritation, indicating their safety for use.

The materials did not cause any liver or kidney dysfunction, and there were no significant differences in organ weights among the groups, supporting their potential for clinical application in wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of dermal irritancy potential of Carboxymethyl-chitosan hydrogel and poly-(acrylic acid) chitin hydrogel. Rattanatayarom, W., Wattanasirichaigoon, S.[2017]

Nonivamide, a synthetic version of capsaicin, showed enhanced skin delivery and pharmacodynamic effects when formulated in hydrogels compared to traditional cream bases, indicating a more effective method for topical application.

The study found that the release rate of nonivamide from hydrogels could be controlled by incorporating specific polymers, which also correlated with skin absorption and effects like vasodilation and skin hydration, suggesting potential for optimized therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro topical application and in vivo pharmacodynamic evaluation of nonivamide hydrogels using Wistar rat as an animal model. Fang, JY., Leu, YL., Wang, YY., et al.[2019]

A novel topical film made from Rhus verniciflua extract-loaded pullulan hydrogel (RVE@PH) was tested on rats with atopic dermatitis (AD) and showed enhanced therapeutic efficacy compared to a standard pullulan hydrogel, indicating that the extract improves treatment outcomes.

The study demonstrated that both the physical properties of the pullulan hydrogel and the pharmaceutical effects of the Rhus verniciflua extract contribute to reducing symptoms of AD, such as dermatitis score and mast cell infiltration, over a 14-day treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical film prepared with Rhus verniciflua extract-loaded pullulan hydrogel for atopic dermatitis treatment. Jeong, JH., Back, SK., An, JH., et al.[2020]

The study characterized new carbomer hydrogels containing escin β-sitosterol (ES) and found that these hydrogels had improved stability and skin retention compared to those containing only escin, making them potentially more effective for topical applications.

Both types of hydrogels demonstrated significant antihyperalgesic effects in a rat model of inflammatory pain, with the ES-loaded hydrogels showing greater efficacy than those with escin, indicating a promising new treatment option for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical hydrogels with escin β-sitosterol phytosome and escin: Formulation development and in vivo assessment of antihyperalgesic activity. Djekic, L., Čalija, B., Micov, A., et al.[2020]

In a study involving 17 adults with mild to moderate atopic dermatitis, the Atrapro antipruritic hydrogel showed significant efficacy in reducing itch and improving skin condition, with a 43% improvement in the investigator global assessment score by day 14 (P < .001).

The hydrogel was well-tolerated, with 82% of participants experiencing relief from itching by day 3, and the only reported adverse event was mild skin dryness in 59% of participants, which resolved with additional emollient use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antipruritic hydrogel for the treatment of atopic dermatitis: an open-label pilot study. Draelos, ZD.[2013]

In a study involving 20 subjects with mild to moderate atopic dermatitis, a water-based hydrogel vehicle significantly improved skin hydration compared to a moisturizing lotion (Eucerin Lotion®).

The hydrogel did not worsen transepidermal water loss (TEWL), while the comparator lotion actually increased TEWL, indicating that the hydrogel is a suitable option for preserving epidermal barrier function in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transepidermal water loss (TEWL) and corneometry with hydrogel vehicle in the treatment of atopic dermatitis: a randomized, investigator-blind pilot study. Kircik, LH.[2012]

The pH-sensitive hydrogel HECHA13, made from hydroxyethyl cellulose and hyaluronic acid, shows excellent drug release efficiency (over 70%) at pH 7, making it suitable for transdermal delivery of treatments for skin lesions.

HECHA13 demonstrated effective antimicrobial activity against Propionibacterium acnes and good skin permeability, primarily through hair follicles, indicating its potential for treating acne.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physicochemical properties of pH-sensitive hydrogels based on hydroxyethyl cellulose-hyaluronic acid and for applications as transdermal delivery systems for skin lesions. Kwon, SS., Kong, BJ., Park, SN.[2015]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4416640/

TriCalm® hydrogel is significantly superior to 2 ...

TriCalm hydrogel significantly reduced peak itch intensity when compared to its own hydrogel vehicle by 1.67±0.42 VAS units, equivalent to a 30.1% reduction (P< ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06748404

TriCalm Hydrogel® in the Treatment of Immunotherapy ...

Topical strontium salts have been found to reduce the duration and severity of histaminergic and nonhistaminergic pruritus. The investigators hypothesize that ...

3.

tandfonline.com

tandfonline.com/doi/abs/10.2147/CCID.S78809

TriCalm® hydrogel is significantly superior to 2% ...

TriCalm hydrogel significantly reduced the peak intensity and duration of cowhage-induced itch when compared to the control itch curve, and was ...

4.

clinicaltrials.ucsd.edu

clinicaltrials.ucsd.edu/trial/NCT06748404

TriCalm Hydrogel® in the Treatment of Immunotherapy ...

The investigators hypothesize that TriCalm Hydrogel® will be effective in reducing the severity of immunotherapy-related pruritus and improve ...

5.

researchgate.net

researchgate.net/publication/275895275_TriCalm_hydrogel_is_significantly_superior_to_2_diphenhydramine_and_1_hydrocortisone_in_reducing_the_peak_intensity_duration_and_overall_magnitude_of_cowhage-induced_itch/download

TriCalm hydrogel is significantly superior to 2 ...

TriCalm hydrogel was eight times more effective than 1% hydrocortisone and almost six times more effective than 2% diphenhydramine in antipruritic action, as ...

6.

dailymed.nlm.nih.gov

dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5cb42ffb-3655-4c38-bf84-1cf33c82df10

Label: TRICALM HYDROGEL- aluminum acetate gel - DailyMed

For external use only. When using this product - Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not apply to open wounds.

7.

tricalm.com

tricalm.com/products/tricalm-hydrogel

TriCalm Hydrogel

The fast-absorbing, steroid-free hydrogel is safe and effective to use as often as needed to ease your family's common skin irritations, including bug bites, ...

8.

walmart.com

walmart.com/ip/TriCalm-Steroid-Free-Soothing-Itch-Relief-Hydrogel-2-fl-oz/35904296

TriCalm Steroid Free Soothing Itch Relief Hydrogel, 2 fl oz

Safe and effective to use as often as needed to ease your entire family's common skin irritations, without the unwanted side effects of steroids.