Skin Barrier Cream + Fluticasone Propionate for Eczema

Not currently recruiting at 8 trial locations

Overseen By Christina Ciaccio, MD MSc

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Kari Nadeau, MD, PhD

Disqualifiers: Chronic disease, Severe skin disorder, Food allergies, 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: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on finding better ways to manage eczema in infants, aiming to reduce its severity and potentially prevent food allergies. Researchers compare two approaches: a proactive treatment using a special skin barrier cream (Epiceram) and a steroid cream (fluticasone propionate) versus the usual care for flare-ups. It targets infants who have shown signs of eczema by 12 weeks old and are generally healthy. Participants should not have any known allergies to the treatment ingredients or other serious skin conditions.

As a Phase 2 trial, the research measures how well the treatment works in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, infants with chronic diseases requiring therapy are excluded, which might imply some restrictions.

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

Research has shown that EpiCeram is a well-tolerated treatment for atopic dermatitis, a type of eczema. The FDA has approved this cream to help repair the skin's protective barrier. It contains no steroids, which can sometimes cause side effects. EpiCeram is designed to relieve symptoms like burning and itching, making it gentle for most users.

Fluticasone propionate cream 0.05% is also considered safe for treating eczema, especially in children aged three months and older. This cream helps reduce redness, itching, and swelling. Although some users might experience skin irritation, this is rare, and stopping the cream usually resolves the issue.

Both treatments are considered safe. EpiCeram focuses on repairing the skin barrier without using steroids, while fluticasone helps control inflammation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Epiceram and Fluticasone Propionate for treating eczema because it offers a proactive approach to managing the condition. Most treatments for eczema involve reactive care, where topical steroids are applied only after a flare-up occurs. However, this new method uses Epiceram, a tri-lipid skin barrier cream, twice daily to strengthen the skin's barrier and potentially prevent flare-ups from happening in the first place. When flare-ups do occur, they're managed with a short course of Fluticasone Propionate, a well-known topical steroid. This dual approach not only aims to reduce the frequency and severity of flare-ups but also leverages a skin barrier cream to maintain healthier skin over the long term.

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

Research has shown that EpiCeram, a special skin cream, can reduce eczema symptoms. Studies found it eased itching and improved sleep in children within 14 to 28 days. EpiCeram performs as well as some moderate-strength steroid creams, making it a strong non-steroid choice for managing eczema. In this trial, participants in the active intervention arm will receive EpiCeram as part of their treatment.

Fluticasone propionate cream 0.05% is another promising treatment option in this trial. Research indicates it is safe for young children and effectively reduces redness, itching, and swelling from eczema. When used twice a week with moisturizers, it can greatly reduce the chances of eczema flare-ups. Together, these treatments could offer a proactive way to manage eczema in infants. ^{6 7 8 9 10}

Who Is on the Research Team?

Kari Nadeau, MD, PhD

Principal Investigator

Harvard

Are You a Good Fit for This Trial?

This trial is for children with early onset eczema (atopic dermatitis) by 12 weeks old, in good health, and without severe skin disorders or chronic diseases. Participants must not have known allergies to study creams or their ingredients and be willing to follow the study procedures.

Inclusion Criteria

In good general health as evidenced by medical history

No known adverse reaction to any of the study medications, their components or excipients

My skin condition or eczema started before I was 12 weeks old.

Exclusion Criteria

Investigator or designee considers that the participant or parent/guardian would be unsuitable for inclusion in the study (for ex/ long stay in NICU)

My infant received antibiotics within the last week.

My infant has a chronic condition needing treatment, like heart disease or diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive proactive sequential skin care with twice-daily use of a tri-lipid skin barrier cream and proactive use of fluticasone propionate cream, or reactive AD therapy

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Epiceram
• Fluticasone Propionate Cream 0.05%
• Moisturizer

Trial Overview The trial tests if proactive skin care using a tri-lipid cream (Epiceram), moisturizer, and fluticasone propionate cream can reduce eczema severity and prevent food allergies compared to standard reactive therapy in infants.

How Is the Trial Designed?

Group I: Active Intervention arm (proactive treatment)- Epiceram Experimental Treatment 2 Interventions

Participants will receive proactive sequential skin care with the twice-daily use of a tri-lipid skin barrier cream (SBC). Clinically apparent eczema in this group will be managed with a short course of topical steroids (fluticasone propionate cream and/or hydrocortisone).

Group II: Control arm (Standard of care) Active Control 1 Intervention

The study doctors will provide standard of care with routine reactive topical products for atopic dermatitis flares

Epiceram is already approved in United States, Canada for the following indications:

Approved in United States as Epiceram for:

• Atopic dermatitis (eczema)
• Dry skin

Approved in Canada as Epiceram for:

• Atopic dermatitis (eczema)
• Dry skin

Who Is Running the Clinical Trial?

Kari Nadeau, MD, PhD

Lead Sponsor

Trials

1

Recruited

310+

Kari Nadeau

Lead Sponsor

Trials

1

Recruited

310+

Kari Christine Nadeau, MD, PhD

Lead Sponsor

Trials

2

Recruited

370+

Sayantani B. Sindher

Lead Sponsor

Trials

2

Recruited

370+

King's College London and Guy's & St. Thomas Hospital

Collaborator

Trials

1

Recruited

310+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Harvard School of Public Health (HSPH)

Collaborator

Trials

283

Recruited

17,030,000+

Guy's and St Thomas' NHS Foundation Trust

Collaborator

Trials

399

Recruited

1,004,000+

King's College London

Collaborator

Trials

772

Recruited

26,130,000+

National Jewish Health

Collaborator

Trials

145

Recruited

318,000+

Published Research Related to This Trial

In a study involving 376 patients with moderate to severe atopic dermatitis, the addition of fluticasone propionate applied twice weekly significantly extended the time to relapse compared to using emollient alone, with median relapse times of over 16 weeks versus 6 weeks.

Patients using fluticasone propionate cream were 5.8 times less likely to experience a relapse, and those using the ointment were 1.9 times less likely, indicating its efficacy in maintaining control of the condition without increasing adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twice weekly fluticasone propionate added to emollient maintenance treatment to reduce risk of relapse in atopic dermatitis: randomised, double blind, parallel group study. Berth-Jones, J., Damstra, RJ., Golsch, S., et al.[2018]

In a 4-week study involving 125 patients with moderate-to-severe psoriasis, fluticasone propionate cream (0.05%) was found to be more effective than hydrocortisone-17-butyrate cream (0.1%), with a higher rate of patients achieving cleared, excellent, or good responses (79% vs. 68%).

Both treatments were generally well-tolerated, with only mild-to-moderate side effects reported, indicating that fluticasone propionate is a safe and effective option for psoriasis management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, multicenter trial comparing fluticasone propionate cream, 0.05%, and hydrocortisone-17-butyrate cream, 0.1%, applied twice daily for 4 weeks in the treatment of psoriasis. James, M.[2015]

Fluticasone propionate, a new topical steroid, was found to be marginally more effective than betamethasone valerate cream in treating psoriasis and eczema, although this difference was not statistically significant.

The study suggests that while fluticasone propionate shows promise, its efficacy is comparable to that of an established treatment, indicating it may be a viable option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluticasone propionate (0.05%) cream compared to betamethasone valerate (0.12%) cream in the treatment of steroid-responsive dermatoses: a multicentric study. Jamkhedkar, P., Shenai, C., Shroff, HJ., et al.[2010]

Fluticasone propionate is a moderate potency topical corticosteroid that shows low potential for systemic side effects, such as HPA axis suppression, due to its high lipophilicity and rapid metabolism in the liver, making it safer for long-term use.

In clinical trials, fluticasone propionate demonstrated similar efficacy to other corticosteroids like hydrocortisone butyrate and betamethasone valerate for treating moderate to severe atopic dermatitis and psoriasis, with a sustained response typically observed after one week of application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical fluticasone propionate: a review of its pharmacological properties and therapeutic use in the treatment of dermatological disorders. Spencer, CM., Wiseman, LR.[2018]

In a study involving 121 patients with moderate-to-severe atopic dermatitis, the ceramide-dominant formulation EpiCeram effectively reduced disease severity, pruritus, and improved sleep habits over 28 days, showing comparable results to fluticasone propionate cream by the end of the trial.

While fluticasone showed faster improvement at 14 days, EpiCeram's results by 28 days suggest it could be a valuable standalone or additional treatment option for pediatric patients with atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a lipid-based barrier repair formulation in moderate-to-severe pediatric atopic dermatitis. Sugarman, JL., Parish, LC.[2022]

Fluticasone propionate is a highly specific topical glucocorticoid with low systemic absorption, showing no evidence of HPA axis suppression even with large doses, indicating a strong safety profile.

The 0.05% cream formulation is effective for treating eczema with once-daily application, demonstrating similar efficacy to twice-daily treatments, and shows comparable effectiveness to stronger corticosteroids in psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluticasone propionate in the treatment of inflammatory dermatoses. Chu, AC., Munn, S.[2015]

EpiCeram, a nonsteroidal lipid barrier emulsion approved by the FDA, effectively manages symptoms of dry skin conditions like atopic dermatitis, showing comparable efficacy to mid-strength topical corticosteroids in a study of 113 children.

EpiCeram has a favorable safety profile with no significant usage restrictions, making it a safer alternative to topical steroids and immunomodulators, which have known side effects and limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epiceram for the treatment of atopic dermatitis. Madaan, A.[2017]

A combination treatment of fluticasone propionate 0.05% cream and clobetasol ointment 0.05% was found to be effective in treating chronic hand eczema in a study of 30 patients.

Topical corticosteroids demonstrated efficacy particularly in mild and moderate cases of hand eczema, suggesting tailored treatment strategies based on disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of two topical corticosteroids in the management of chronic hand eczema. Gola, M., D'Erme, AM., Milanesi, N.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3368745/

A phase i study of daily treatment with a ceramide-dominant ... One such cream, EpiCeram™, has been demonstrated to have a similar impact on eczema severity over a 28 day treatment period as a moderate strength topical ...

2. jddonline.com jddonline.com/articles/efficacy-of-a-lipid-based-barrier-repair-formulation-in-moderate-to-severe-pediatric-atopic-dermatit-S154596169P1106X?fbclid=IwY2xjawJp4elleHRuA2FlbQIxMQABHvkcdDKRoWccI-dd9_KtI4bN1zKTuR_wevE7A1nludp-RxnLuxpxvlZfjFzV_aem_Mdg3RdWgodCjZmboO5dFLw

Efficacy of a Lipid-Based Barrier Repair Formulation in ... Results: EpiCeram reduced clinical disease severity, decreased pruritus and improved sleep habits both 14 and 28 days after initiation of therapy. Although the ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03742414

NCT03742414 | Seal, Stopping Eczema and Allergy Study The aim is to compare the effect of proactive sequential skin care, including the twice-daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3244356/

Nonsteroidal Treatment of Atopic Dermatitis in Pediatric ... Treatment success based on an Investigator Global Assessment rating of clear or almost clear was achieved by 58 percent of subjects after use of the ceramide- ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1081120622000151

Optimizing emollient therapy for skin barrier repair in atopic ... By 28 days, patients treated with EpiCeram alone exhibited reductions in SCORAD scores that were comparable to fluticasone. Moreover, EpiCeram treatment not ...

6. epiceramrx.com epiceramrx.com/patients.html

Patients EpiCeram Controlled Release Skin Barrier Emulsion is an atopic dermatitis treatment that aims to help repair the skin barrier abnormalities in atopic dermatitis ...

7. accessdata.fda.gov accessdata.fda.gov/CDRH510K/K052643.pdf

APR ! 1 2006 - accessdata.fda.gov EPICERAMCR is a skin barrier emulsion to be used to treat xerotic skin conditions by reducing excessive transepidermnal water loss through the.

8. epiceramrx.com epiceramrx.com/hcp.html

Healthcare Practitioners EpiCeram is steroid-free, fragrance-free, noncomedogenic, paraben-free, and propylene glycol-free. Help to repair the Skin Barrier with EpiCeram. Only topical ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19137128/

Epiceram for the treatment of atopic dermatitis EpiCeram was approved by the FDA in April 2006 for use as a nonsteroidal lipid barrier emulsion to manage symptoms of burning and itching associated with dry ...

10. empr.com empr.com/drug/epiceram/

EPICERAM Prescription & Dosage Information - MPR To treat dry skin conditions and to manage and relieve burning and itching associated with various types of dermatoses, including atopic dermatitis, irritant ...