Eucrisa for Eczema

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Wake Forest University Health Sciences

Must not be taking: Systemic therapies, Topical corticosteroids

Disqualifiers: Pregnancy, Allergy to crisaborole, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of Eucrisa (crisaborole 2% ointment) for individuals with mild to moderate eczema. Participants will apply the ointment twice daily. The study will compare two groups: one following standard treatment and another receiving additional online support to encourage regular use. Ideal candidates have eczema covering at least 5% of their body and have not recently used specific eczema treatments. The trial will last 12 months, with visits to monitor progress and adjust treatment plans as needed. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to early-stage medical research.

Will I have to stop taking my current medications?

The trial requires that you stop using any systemic therapy for atopic dermatitis at least 4 weeks before starting and any prescription topical therapy for atopic dermatitis at least 2 weeks before starting. If you're using other medications, the protocol does not specify, so it's best to discuss with the study team.

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

Research has shown that Eucrisa (crisaborole) is generally safe for treating mild to moderate eczema (also known as atopic dermatitis). In studies, the most common side effect was a mild burning or stinging sensation at the application site, which typically resolves on its own shortly after use.

The FDA has approved Eucrisa for use in adults and children over 3 months old, indicating its safety. A long-term study lasting 52 weeks found that patients using Eucrisa did not experience any serious side effects.

It is important to note that Eucrisa should not be used by anyone allergic to its ingredients. Otherwise, current evidence suggests the treatment is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Eucrisa is unique because it uses crisaborole, a non-steroidal anti-inflammatory ointment, which makes it stand out from traditional steroid-based treatments for eczema. Unlike steroid creams that can thin the skin with long-term use, Eucrisa targets the inflammation directly with fewer side effects. Researchers are also exploring an innovative approach by incorporating electronic treatment response emails, aiming to enhance patient engagement and improve treatment outcomes. This combination of a novel active ingredient and a tech-driven response system is what has researchers excited about its potential benefits for eczema patients.

What evidence suggests that Eucrisa might be an effective treatment for eczema?

Research has shown that Eucrisa (crisaborole) effectively treats mild to moderate eczema. One study found that 51.7% of patients using Eucrisa saw improvement, compared to 40.6% who used a non-medicated ointment. Another study revealed that about one-third of patients achieved clear or almost clear skin after using Eucrisa. In this trial, all participants will receive Eucrisa, with one group following standard care and the other receiving electronic treatment response emails. These findings suggest that Eucrisa can significantly alleviate eczema symptoms for many individuals. ^{6 7 8 9 10}

Who Is on the Research Team?

Lindsay C Strowd, MD, FAAD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for males and females aged 2-64 with mild to moderate atopic dermatitis covering 5% or more of their body. Participants must be able to follow the study procedures, provide consent, and not be using certain other treatments or have conditions that would increase risk.

Inclusion Criteria

I can follow the study's procedures and attend all visits.

The ability to understand and sign a written informed consent/assent form, which must be obtained prior to treatment

I am between the ages of 2 and 64.

Exclusion Criteria

I haven't used systemic therapy for eczema in the last 4 weeks.

Any other condition, which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study

I haven't used prescription skin creams for eczema in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topical crisaborole 2% ointment (Eucrisa®) and adherence is monitored using MEMS caps over a 12-month period

12 months

Baseline visit, follow-up visits at 1, 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Eucrisa
• Online Treatment response

Trial Overview The effectiveness of Eucrisa (crisaborole) ointment in treating atopic dermatitis is being tested. Patients will apply it twice daily for a year, with usage monitored by special caps on the tubes. An online survey aims to improve adherence.

How Is the Trial Designed?

Group I: Arm 2 - Online Treatment Response Experimental Treatment 2 Interventions

Subjects receive study medication, EUCRISA (crisaborole) ointment 2%, and electronic treatment response emails

Group II: Arm 1 - Standard of Care Active Control 1 Intervention

Subjects receive study medication, EUCRISA (crisaborole) ointment 2%, and follow standard of care

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

A review of 24 studies on emollients for atopic dermatitis found that while adverse events were reported, none were serious, suggesting that these treatments are generally safe for use.

The most common adverse events were mild skin reactions, with the proportion of participants experiencing treatment-related issues ranging from 2% to 59%, highlighting the need for better reporting and more comprehensive studies on emollient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events from Emollient Use in Eczema: A Restricted Review of Published Data. Bhanot, A., Huntley, A., Ridd, MJ.[2021]

Topical corticosteroids (TCS) used for atopic eczema showed no significant increased risk of skin thinning in short-term studies, indicating they are generally safe for use in both adults and children.

While TCS may have a higher relative risk of skin thinning compared to topical calcineurin inhibitors, the overall long-term safety data is limited, suggesting that intermittent use of TCS is safe but requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of topical corticosteroids in atopic eczema: an umbrella review. Axon, E., Chalmers, JR., Santer, M., et al.[2023]

Eucerin Eczema Relief Body Crème and Instant Therapy cream were tested in children aged 3 months to 12 years, showing significant improvements in skin hydration and reduction of atopic dermatitis symptoms, including itching and redness.

Both products were found to be safe and well tolerated, providing effective steroid-free options for managing atopic dermatitis in infants and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Tolerability of Steroid-Free, Over-the-Counter Treatment Formulations in Infants and Children With Atopic Dermatitis. Weber, TM., Herndon, JH., Ewer, M., et al.[2020]

Topical calcineurin inhibitors, like Protopic and Elidel, are effective treatments for atopic eczema, but their use has been accompanied by a 'black box warning' from the FDA due to safety concerns.

The report reviews the evidence behind this warning and discusses the ongoing debate among dermatological societies regarding the safety and efficacy of these medications, highlighting the need for informed decision-making among patients and parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current aspects of the therapy with topical calcineurin inhibitors]. Enderlein, E., Meller, S., Rieker, J., et al.[2018]

Topical tacrolimus ointment has been shown to be effective for treating atopic dermatitis, with its safety and efficacy established through various clinical trials lasting up to 12 weeks and comparative studies with topical steroids.

Long-term safety studies extending up to 4 years provide additional reassurance about the use of tacrolimus ointment, addressing clinicians' concerns regarding its prolonged use in patients with atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of tacrolimus ointment: a clinical review. Beck, LA.[2013]

In a study involving 2034 patients with mild to moderate atopic eczema, pimecrolimus cream 1% applied twice daily led to treatment success in 59% of patients after 3 months, with 81% achieving clear or almost clear skin on the face.

Pimecrolimus cream demonstrated a favorable safety profile, with 79% of patients experiencing absent or mild itching, making it a suitable long-term treatment option for delicate areas like the face.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Control of atopic eczema with pimecrolimus cream 1% under daily practice conditions: results of a > 2000 patient study. Ring, J., Abraham, A., de Cuyper, C., et al.[2022]

Pimecrolimus cream 1% is effective in treating atopic eczema, providing rapid relief from itching and reducing redness and swelling in up to 70% of patients within the first three weeks of treatment.

It is well tolerated, even on sensitive skin areas like the face and neck, with low blood concentrations and no significant systemic side effects observed in both short- and long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pimecrolimus: a review of pre-clinical and clinical data. Graham-Brown, RA., Grassberger, M.[2014]

The Eucerin Eczema Relief Body Cream significantly improved skin hydration and barrier function in subjects with atopic dermatitis over 14 days, with effects lasting through a 5-day withdrawal period, and 93.8% of participants experienced reduced itching.

The Eucerin Eczema Relief Instant Therapy provided rapid relief for active atopic dermatitis lesions, improving skin hydration and symptoms like redness and itching within minutes, while also enhancing the quality of life for users. Both products were found to be safe and well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Steroid-free emollient formulations reduce symptoms of eczema and improve quality of life. Weber, TM., Babcock, MJ., Herndon, JH., et al.[2014]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK542352/

Results - Clinical Review Report: Crisaborole Ointment ... - NCBI The proportion of patients with success was higher with crisaborole than vehicle in studies AD-301 (51.7% versus 40.6%, P = 0.005) and AD-302 (48.5% versus 29.7 ...

2. eucrisa.com eucrisa.com/results-you-can-see

EUCRISA® (crisaborole) Clinical Trial Photos and Results In trials of people ages 2 and up, more people using EUCRISA twice daily (32%) achieved clear or almost clear skin versus those using non-medicated ointment (22 ...

3. aafp.org aafp.org/pubs/afp/issues/2018/0915/p379.html

Crisaborole (Eucrisa) for Mild to Moderate Atopic Dermatitis Crisaborole has been shown to be effective in about one-third of patients who use it, but it is much more expensive than other available ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38340127/

Efficacy and safety of crisaborole ointment, 2%, in ... Results: Crisaborole-treated participants had significantly reduced total sign score from baseline versus vehicle based on in-person (nondermatologist) ...

5. fda.gov fda.gov/media/168495/download

NDA 207695/S-12 Eucrisa (crisaborole) ointment, 2% The statistical team identified one clinical site with a large treatment effect which impacted the efficacy results on the recommended primary ...

6. eucrisa.pfizerpro.com eucrisa.pfizerpro.com/safety-data/52-week-trial

Safety - 52 Week Trial Review the safety data from a study design for a 52-week trial in which patients who had responded to twice-daily application were switched to a once-daily ...

7. eucrisa.com eucrisa.com/safety-and-side-effects

Safety and Side Effects of EUCRISA® (crisaborole) Read about the safety and side effects of EUCRISA®, an Rx topical ointment for mild-to-moderate eczema in adults and children ages 3 months and older.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/207695s007s009s010lbl.pdf

EUCRISA™ (crisaborole) - accessdata.fda.gov The safety and effectiveness of EUCRISA have been established in pediatric patients ages 3 months and older for topical treatment of mild to moderate atopic ...

9. eucrisa.pfizerpro.com eucrisa.pfizerpro.com/api/vc/en/content/material/c8e3ab4e-452c-42c5-bae6-e80f9f96c525/EUCRISAcrisaborole_SafetyInfo_PrescribingInfo_PP-CRI-USA-2885.pdf

Cas e R eport Efficacy & Safety Data EUCRISA is contraindicated in patients with known hypersensitivity to crisaborole or any component of the formulation. Please see Full Prescribing Information.

10. eucrisa.com eucrisa.com/treating-eczema

Treating Eczema with EUCRISA® (crisaborole) | Safety Info Read about treating eczema with EUCRISA®, a Rx topical ointment for mild-to-moderate eczema (atopic dermatitis), for patients ages 3 months and older.