Skin Barrier Cream + Fluticasone Propionate for Eczema

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

312 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether using a special moisturizing cream and a mild steroid cream can help infants with early signs of eczema. The goal is to see if this treatment can reduce eczema severity and prevent food allergies. The study focuses on very young babies who have dry skin or early eczema symptoms. EpiCeram™ has been previously tested for preventing eczema in infants with a family history of allergic disease.

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.

What data supports the effectiveness of the treatment Skin Barrier Cream + Fluticasone Propionate for Eczema?

Research shows that EpiCeram, a skin barrier cream, is effective in managing symptoms of eczema and has a favorable safety profile. Fluticasone propionate cream is also effective in treating eczema with a high safety profile, making the combination of these treatments potentially beneficial for eczema management. ^{1 2 3 4 5}

Is the combination of Skin Barrier Cream and Fluticasone Propionate safe for humans?

EpiCeram, a skin barrier cream, has a favorable safety profile and does not have significant usage restrictions. Fluticasone Propionate cream is a topical steroid with low systemic absorption and no significant side effects like skin thinning or hormonal suppression when used as directed. ^{1 3 4 5 6}

How is the drug Skin Barrier Cream + Fluticasone Propionate unique for treating eczema?

This treatment combines a lipid-based barrier repair cream (EpiCeram) with fluticasone propionate, a topical steroid, to address both the skin barrier dysfunction and inflammation in eczema. The combination aims to enhance skin repair while reducing inflammation, offering a comprehensive approach compared to using a steroid alone. ^{1 3 4 7 8}

Research Team

Kari Nadeau, MD, PhD

Principal Investigator

Harvard

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States 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. [2010]

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

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

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

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

4. England pubmed.ncbi.nlm.nih.gov

Fluticasone propionate in the treatment of inflammatory dermatoses. [2015]

5. Spain pubmed.ncbi.nlm.nih.gov

Epiceram for the treatment of atopic dermatitis. [2017]

6. United States 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. [2015]

7. England 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. [2018]

8. Italy pubmed.ncbi.nlm.nih.gov

Clinical efficacy of two topical corticosteroids in the management of chronic hand eczema. [2015]