Topical Treatment for Eczema

Overseen By Irma Richardson, MHA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: No dermatitis, BSA <2%, 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: 2

Duration: 1 week

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different methods of instruction can improve the use of triamcinolone cream for eczema, a skin condition causing itchy, inflamed patches. The study compares three ways to guide patients: a mobile app, live demonstrations, and standard written or verbal instructions. Researchers seek to determine which method enhances treatment adherence, as non-adherence often results in worse health outcomes and higher costs. Individuals with active eczema who are receiving dermatologic care and can attend a follow-up appointment after a week may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance treatment adherence and outcomes for eczema patients.

Will I have to stop taking my current medications?

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

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

Research has shown that triamcinolone cream is usually safe and effective when applied to the skin. It often helps reduce redness, itching, and swelling from conditions like eczema. Many people use it without major issues, though some may experience mild side effects such as skin irritation or dryness. Doctors frequently prescribe this cream for skin problems, indicating its safety. While monitoring for any reactions is important, most users find it both safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative methods to improve how patients apply triamcinolone cream for eczema. Unlike the standard approach of written or verbal instructions, one arm of the trial uses a mobile application to guide patients in applying the cream, potentially improving adherence and effectiveness. Another approach includes a live demonstration to teach patients the precise amount of cream to use, which could enhance treatment accuracy. These methods aim to optimize the cream's effectiveness by ensuring it's applied correctly, offering hope for better management of eczema symptoms.

What evidence suggests that this trial's treatments could be effective for eczema?

Research has shown that triamcinolone cream effectively treats eczema. In one study, patients experienced a 45.6% reduction in itching after six days of use, which improved to 60% by the study's end. Another study found that the cream significantly reduced both itching and dryness. Triamcinolone cream, a topical corticosteroid, is commonly used for skin conditions like eczema. In this trial, participants will be divided into groups: one group will use a mobile app designed to help users apply the cream correctly, potentially enhancing its effectiveness; another group will observe a live demonstration; and a third group will receive standard written and verbal instructions. ^{3 6 7 8 9}

Who Is on the Research Team?

Steven Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for individuals with atopic dermatitis, commonly known as eczema. It's designed to help those who struggle with following their medication regimen consistently.

Inclusion Criteria

I have been diagnosed with skin dermatitis.

I am older than 9 years.

Ability to return for a one-week clinical studies follow-up

Exclusion Criteria

I do not have skin dermatitis.

Less than 2% of my body is affected by my condition.

I cannot come back for a follow-up in one week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive topical treatment with triamcinolone cream, with different groups receiving varying levels of instruction on application

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in body surface area affected and other measures after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Triamcinolone cream

Trial Overview The study is testing the effectiveness of a mobile app in improving treatment adherence compared to standard care. Participants will also be shown how to apply triamcinolone cream properly.

How Is the Trial Designed?

Group I: Written/verbal instructions only Experimental Treatment 1 Intervention

Standard of care written/verbal instructions only

Group II: Mobile Application Experimental Treatment 1 Intervention

Additional mobile application that provides instructions to apply the medication (triamcinolone cream)

Group III: Demonstration Active Control 1 Intervention

Observe a live demonstration instructing how to dispense 1 fingertip unit (FTU) of medication (triamcinolone cream) per 1% body surface area

Triamcinolone cream is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Triamcinolone cream for:

• Atopic dermatitis
• Eczema
• Psoriasis
• Contact dermatitis
• Seborrheic dermatitis

Approved in European Union as Triamcinolone cream for:

• Atopic dermatitis
• Eczema
• Psoriasis
• Contact dermatitis
• Seborrheic dermatitis

Approved in Canada as Triamcinolone cream for:

• Atopic dermatitis
• Eczema
• Psoriasis
• Contact dermatitis
• Seborrheic dermatitis

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

In a double-blind multicentre trial involving 193 patients with various skin disorders, bufexamac showed no significant clinical improvement compared to placebo, indicating limited efficacy as an anti-inflammatory treatment.

Both 0.1% triamcinolone acetonide and 1% hydrocortisone cream were significantly more effective than bufexamac after 2 and 4 weeks of treatment, highlighting their superiority in managing skin conditions like atopic dermatitis and allergic contact dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of bufexamac (NFN) cream in skin diseases. A double-blind multicentre trial. Christiansen, JV., Gadborg, E., Kleiter, I., et al.[2019]

In a study of 145 patients with severe bronchial asthma, repeated intramuscular injections of triamcinolone acetonide (Kenalog) resulted in excellent or good outcomes in 88.3% of cases, indicating its high efficacy for patients who did not respond to other treatments.

While Kenalog was effective, 13.8% of patients experienced side effects such as weight gain and increased blood pressure, highlighting the need for careful monitoring during prolonged steroid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. Romański, B., Pawlik, K., Wilewska-Klubo, T.[2013]

In a study involving 30 patients with mild to moderate bilateral atopic eczema, both a new purified coal tar cream (Clinitar) and 1% hydrocortisone cream were equally effective in reducing symptoms over a 4-week treatment period.

Patients showed no preference for either treatment in terms of cosmetic acceptability, indicating that both options are viable for managing eczema symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative trial of Clinitar versus hydrocortisone cream in the treatment of atopic eczema. Munkvad, M.[2019]

The triple combination cream (Tri-Luma) containing 0.05% tretinoin, 4.0% hydroquinone, and 0.01% fluocinolone acetonide has been shown to be effective in treating melasma, with 29% of patients achieving complete clearing and 77% showing significant improvement after 8 weeks in a study involving over 2000 patients.

The safety profile of Tri-Luma is favorable, with adverse events being mostly mild and localized, and only two cases of skin atrophy reported in extensive studies, indicating low risk for serious side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive review of the long-term and short-term treatment of melasma with a triple combination cream. Torok, HM.[2018]

In a study involving 62 patients with psoriasis or eczema, 0.05% betamethasone dipropionate cream was found to be more effective than 0.025% fluocinolone acetonide cream, with 57% of patients on betamethasone reporting significant improvement.

Both treatments were well tolerated and cosmetically acceptable, indicating their safety for use in managing skin conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind controlled trial of betamethasone dipropionate 0.05% (Diproderm) in comparison with fluocinolone acetonide 0.025% (Synalar) in psoriasis and other steroid-responsive dermatoses. Afzelius, HW., Jacobsen, KU.[2017]

Intralesional Kenalog (triamcinolone) is an effective treatment for skin conditions like nodulocystic acne, demonstrating its therapeutic potential.

However, this case highlights a rare but significant side effect: a granulomatous reaction, indicating that while the treatment is beneficial, it can also lead to adverse histopathological responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Granulomatous Reaction to Intralesional Kenalog (Triamcinolone) Injection in Acne: A Case Report. Song, Y., Guo, Y.[2020]

In a double-blind study involving 21 patients with acute eczema, triamcinolone acetonide benzoyl-beta-amino-isobutyrate (TBI) showed similar efficacy to betamethasone dipropionate in treating the condition.

Both corticosteroids were well-tolerated by patients, indicating that TBI can be considered an effective alternative to betamethasone for eczema treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical treatment of eczema with triamcinolone acetonide benzoyl-beta-amino-isobutyrate: a double-blind comparison with betamethasone dipropionate. Roessel, FE.[2017]

In a study involving 14 patients with atopic dermatitis, a low-dose triamcinolone acetonide (TACA) cream (25 microg/g) combined with Lichtena significantly improved skin lesions compared to plain Lichtena, with noticeable effects observed as early as one week into treatment.

The results suggest that TACA can be effective at much lower concentrations (up to 40 times lower than typical commercial products), indicating a potential for safer and more effective treatment options for atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose triamcinolone acetonide in the phytocosmetic lichtena reduces inflammation in mild to moderate atopic dermatitis. Pellanda, C., Weber, M., Bircher, A., et al.[2013]

Pimecrolimus cream is effective in treating both acute and chronic stages of atopic eczema in children, helping to reduce the occurrence of flares that require stronger topical corticosteroids.

The cream has a favorable safety profile, with mild side effects and no increase in infections or systemic immune suppression, making it a safe option for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pimecrolimus cream in the management of patients with atopic eczema. Spergel, JM.[2021]

Citations

1. 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, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4524501/

The effects of treatment on itch in atopic dermatitis - PMC After six days of using the study cream, patient-reported pruritus was 45.6% lower compared with baseline and at study end, pruritus had diminished by 60%. They ...

3. 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, ...

4. 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 ...

5. aafp.org aafp.org/pubs/afp/issues/2021/0315/p337.html

Topical Corticosteroids: Choice and Application Topical corticosteroids are an essential tool for treating inflammatory skin conditions such as psoriasis and atopic dermatitis.

6. 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.

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

Triamcinolone Acetonide topical (Aristocort, Kenalog, and ... Topical triamcinolone is commonly used to reduce inflammation and itching of the skin. Topical triamcinolone may also be used for other conditions as ...

8. healio.com healio.com/clinical-guidance/drugs/triderm

Triderm: Uses, Side Effects & Dosage This medication is used to treat a variety of skin conditions (such as eczema, dermatitis, allergies, rash). Triamcinolone reduces the swelling, ...

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

Aristocort, Topical cream No genotoxicity studies have been conducted with triamcinolone acetonide. Aristocort cream contains the following excipients: emulsifying wax, isopropyl ...