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

Trial Summary

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.

What data supports the effectiveness of the treatment TriCalm Hydrogel® for itchiness?

Research on similar hydrogels shows they can improve skin hydration and reduce itchiness in conditions like atopic dermatitis, suggesting that TriCalm Hydrogel® might also help with itchiness by keeping the skin moist and soothing irritation. ^{1 2 3 4 5}

How does TriCalm Hydrogel differ from other treatments for itchiness?

TriCalm Hydrogel is unique because it uses a hydrogel formulation, which can enhance the delivery and retention of active ingredients on the skin, potentially providing more effective relief from itchiness compared to traditional creams or ointments. This type of formulation is designed to improve the permeation and distribution of the active components, offering a novel approach to managing itchiness. ^{1 3 6 7 8}

What is the purpose of this trial?

This is a phase 2, randomized, open-label, single-center study that will assess the efficacy of TriCalm Hydrogel®, a topical gel containing strontium, for treating pruritus related to immune checkpoint inhibitors (ICIs).

Research Team

Karen M Yun, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Thailand pubmed.ncbi.nlm.nih.gov

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

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

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

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

Topical film prepared with Rhus verniciflua extract-loaded pullulan hydrogel for atopic dermatitis treatment. [2020]

4. United States 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. [2012]

5. Netherlands 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. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Drug delivery system of dual-responsive PF127 hydrogel with polysaccharide-based nano-conjugate for textile-based transdermal therapy. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

In vitro topical application and in vivo pharmacodynamic evaluation of nonivamide hydrogels using Wistar rat as an animal model. [2019]

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

Topical hydrogels with escin β-sitosterol phytosome and escin: Formulation development and in vivo assessment of antihyperalgesic activity. [2020]