Steroid Cream for Eczema

No longer recruiting at 1 trial location

Overseen By Fareheen Chowdhury

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Innovaderm Research Inc.

Disqualifiers: Pregnancy, Skin disease, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a steroid cream called Triamcinolone Acetonide (Aristocort® C) to evaluate its effectiveness for people with eczema. Researchers compare it to a placebo to assess its short-term effectiveness for atopic dermatitis, a type of eczema. Individuals who have had eczema for at least six months and have not experienced significant flare-ups in the last four weeks might be suitable candidates. Participants must have specific areas of eczema on their skin that can be treated during the study. As a Phase 4 trial, this research examines an FDA-approved treatment to understand its benefits for more patients.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the safety track record for Triamcinolone Acetonide (Aristocort® C)?

Research shows that triamcinolone acetonide, found in creams like Aristocort® C, is generally safe for treating skin problems. Studies indicate it reduces redness, itching, and swelling. Most users might experience mild side effects such as skin irritation, itching, or dryness, which are usually minor and resolve over time. Triamcinolone acetonide has long been used to treat conditions like eczema, psoriasis, and dermatitis, suggesting it is well-tolerated. As this cream is in a Phase 4 trial, it has already received approval for other uses, supporting its safety in humans. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Triamcinolone Acetonide (Aristocort® C) is unique because it offers a potent anti-inflammatory effect for eczema sufferers. Unlike many standard treatments like hydrocortisone, which are often milder, triamcinolone is a stronger corticosteroid, making it effective for more severe cases of eczema. Researchers are excited about this treatment because it can provide quicker relief from symptoms, potentially reducing the frequency of flare-ups and improving quality of life for those with persistent eczema. Additionally, its targeted action helps to minimize systemic exposure, which could reduce the risk of side effects often associated with oral steroids.

What is the effectiveness track record for Triamcinolone Acetonide (Aristocort® C) in treating eczema?

Research shows that triamcinolone acetonide, the main ingredient in Aristocort® C, effectively treats atopic dermatitis, also known as eczema. Studies have found that this steroid cream greatly reduces itching, dryness, and swelling, common symptoms of eczema. Clinical evidence confirms that triamcinolone is a popular choice for managing eczema because it quickly improves skin condition and comfort. For those with eczema, this treatment has proven to provide relief and enhance quality of life. Participants in this trial will receive either triamcinolone acetonide or a placebo vehicle to further evaluate its effectiveness. ^{4 6 7 8 9}

Who Is on the Research Team?

Robert Bissonnette, MD

Principal Investigator

Innovaderm Research Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a confirmed diagnosis of active atopic dermatitis (AD), based on specific criteria. They must have stable AD without significant flares for the last 4 weeks and two areas of skin affected. Excluded are those with immune deficiencies, chronic infections, allergies to the study drug, pregnant or breastfeeding women, certain skin types, other interfering skin conditions or cancer within the past 5 years.

Inclusion Criteria

I have been diagnosed with active atopic dermatitis.

I have had atopic dermatitis for over 6 months with no severe flare-ups in the last 4 weeks.

I have two skin areas, each at least 6cm by 6cm, suitable for treatment.

Exclusion Criteria

You have a weakened immune system.

I have a long-term infectious disease.

I am allergic to triamcinolone acetonide or components of the study drug.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive twice-daily topical application of triamcinolone acetonide (Aristocort® C) or vehicle for 3 days

3 days

Daily visits for application and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Triamcinolone Acetonide (Aristocort® C)

Trial Overview The trial tests Triamcinolone Acetonide (Aristocort® C) against a placebo ('Vehicle') in subjects with atopic dermatitis. It's designed as an intraindividual study where each subject receives both treatments on different parts of their body to compare effectiveness directly.

How Is the Trial Designed?

Group I: Triamcinolone Acetonide (Aristocort® C) Active Control 1 Intervention

Group II: Vehicle Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Innovaderm Research Inc.

Lead Sponsor

Trials

49

Recruited

3,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05844618?term=AREA%5BBasicSearch%5D(TRIAMCINOLONE%20ACETONIDE)&rank=4

Short-Term Efficacy of Triamcinolone Acetonide (Aristocort ... This study is being conducted to evaluate the short-term efficacy and effect of triamcinolone acetonide (Aristocort® C) on pruritus, skin biomarkers and skin ...

2. clinicaltrial.be clinicaltrial.be/en/details/268012?only_eligible=0&only_recruiting=0&per_page=100

Short-Term Efficacy of Triamcinolone Acetonide (Aristocor... This study is being conducted to evaluate the short-term efficacy and effect of triamcinolone acetonide (Aristocort® C) on pruritus, skin biomarkers and skin ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK544309/

Triamcinolone - StatPearls - NCBI Bookshelf Triamcinolone is a glucocorticoid used for the management of diverse medical conditions, including atopic dermatitis, contact dermatitis (eg, poison ivy), ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.16208

Comparison of the effect of topical triamcinolone 0.1% ... Findings showed that both triamcinolone (0.1%) and sulfur (2.0%) creams could significantly reduce the scores of HECSI, itching, dryness, ...

5. jacionline.org jacionline.org/article/S0091-6749(23)01113-2/fulltext

Topical treatments for atopic dermatitis (eczema) With high-certainty evidence, pimecrolimus improved 6 of 7 outcomes—among the best for 2; high-dose tacrolimus (0.1%) improved 5—among the best ...

6. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/a/aristocortcrmoint.pdf

Aristocort, Topical cream No genotoxicity studies have been conducted with triamcinolone acetonide. Triamcinolone acetonide had no adverse effect on fertility in male or female rats.

7. mayoclinic.org mayoclinic.org/drugs-supplements/triamcinolone-topical-application-route/description/drg-20073937

Triamcinolone (topical application route) - Side effects & ... Triamcinolone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions.

8. webmd.com webmd.com/drugs/2/drug-5217/triamcinolone-acetonide-top-topical/details

Triamcinolone Acetonide topical (Aristocort, Kenalog, and ... What are the most common side effects of topical triamcinolone? · Local skin irritation, rash, itching, burning, or dryness · Pale skin · Thin skin ...

9. drugs.com drugs.com/triamcinolone-acetonide-cream.html

Triamcinolone Acetonide Cream: Uses, Dosage, Side ... Triamcinolone Acetonide cream is used for psoriasis, eczema, dermatitis, rashes, and other itchy or inflamed skin conditions.