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

Trial Summary

What is the purpose of this trial?

Medication adherence is a poorly studied phenomenon that challenges both patients and physicians. 50% of individuals with chronic disease are not adherent to their medication regimen. Within the United States, non-adherence to medical treatment leads to approximately $100 billion in hospital admission costs. While the issue of adherence is not limited to any particular field of medicine, non-adherence occurs in approximately one-third to one-half of dermatological patients. Non-adherence is of importance as it is a significant cause of treatment failure, resulting in worse quality of life, worse health outcomes, and increased insurance costs.

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.

What data supports the effectiveness of the drug Triamcinolone cream for treating eczema?

Research shows that triamcinolone acetonide, a key ingredient in the cream, is effective in treating various skin conditions, including eczema. In a study comparing it to another steroid cream, triamcinolone was found to be equally effective in improving eczema symptoms. ^{1 2 3 4 5}

Is Triamcinolone cream safe for use in humans?

Triamcinolone cream, used for various conditions, has been shown to be generally safe in humans. Some side effects like weight gain, changes in menstruation, and increased blood pressure have been reported, but they are not common. In studies, adverse effects were usually mild and occurred at the application site. ^{1 2 3 6 7}

How is Triamcinolone cream different from other eczema treatments?

Triamcinolone cream is a topical corticosteroid that can be effective at lower concentrations than other commercial products, which may reduce the risk of side effects while still effectively treating eczema. ^{1 4 7 8 9}

Research Team

Steven Feldman, MD, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of bufexamac (NFN) cream in skin diseases. A double-blind multicentre trial. [2019]

2. Singapore pubmed.ncbi.nlm.nih.gov

The use of triamcinolone acetonide in the treatment of severe intrinsic bronchial asthma. [2013]

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

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

4. England 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. [2017]

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

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

6. New Zealand pubmed.ncbi.nlm.nih.gov

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Low-dose triamcinolone acetonide in the phytocosmetic lichtena reduces inflammation in mild to moderate atopic dermatitis. [2013]

8. England pubmed.ncbi.nlm.nih.gov

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

9. New Zealand pubmed.ncbi.nlm.nih.gov

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