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

28 Participants Needed

Trial Summary

What is the purpose of this trial?

Patients with mild to moderate atopic dermatitis will be asked to participate in helping the study team determine how well the medication works for atopic dermatitis. Participants will not be told that adherence will be monitored. Patients will be dispensed topical crisaborole 2% ointment (Eucrisa®) in a medication tube fitted with a Medication Event Monitoring System (MEMS) cap if they agree to participate. This cap records dates and times the bottle is opened and this data can be downloaded and tabulated with the associated software. Investigators and subjects will be blinded to the adherence data until the final treatment (12 month) session. The study subjects will be randomized to two groups. After baseline visit, both groups will come for a follow-up visit at 1 month, 3 months, 6 months, and 12 months. The intervention group will also be asked to complete an online treatment response survey designed to improve adherence at weekly intervals for 6 weeks, then monthly thereafter. The study will consist of a 12-month Treatment Phase. Study subjects will be instructed to apply the medication twice daily (morning and evening) to all of their AD lesions. They will be instructed to apply the smallest amount of study medication possible that is sufficient to cover all lesions. These instructions are standard-of-care for patients with AD. Subjects will be asked to bring their medication tubes with them at each visit. At each visit, the study coordinator will weigh the medication tube and download the MEMS cap data. Disclosure of the adherence monitoring will occur at the 12 month visit (or end of treatment), at which time the results of the subject's adherence behavior will be used to supply individualized treatment options for each subject (feedback session). At each visit, drug tubes will be measured for weight to determine the amount of study medication used. This data will be correlated with the extent of BSA involved and the response of the disease. The MEMS caps will be downloaded at each visit.

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 Eucrisa safe for treating eczema?

The research articles provided do not contain specific safety data for Eucrisa (crisaborole) for eczema or other conditions. Therefore, no relevant safety information is available from these sources. ^{1 2 3 4 5}

How does the drug Eucrisa differ from other eczema treatments?

Eucrisa is unique because it is a non-steroidal topical treatment specifically designed to target eczema without the side effects associated with steroids, such as skin thinning. It works by inhibiting an enzyme called phosphodiesterase 4 (PDE4), which helps reduce inflammation and improve skin condition. ^{6 7 8 9 10}

Research Team

Lindsay C Strowd, MD, FAAD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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.

I am between the ages of 2 and 64.

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

Exclusion Criteria

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

Adverse Events from Emollient Use in Eczema: A Restricted Review of Published Data. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Safety of topical corticosteroids in atopic eczema: an umbrella review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Emollients and moisturizers for eczema: abridged Cochrane systematic review including GRADE assessments. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Current aspects of the therapy with topical calcineurin inhibitors]. [2018]

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

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

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

Efficacy and Tolerability of Steroid-Free, Over-the-Counter Treatment Formulations in Infants and Children With Atopic Dermatitis. [2020]

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

The role of pimecrolimus cream 1% (Elidel)) in managing adult atopic eczema. [2014]

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

Control of atopic eczema with pimecrolimus cream 1% under daily practice conditions: results of a > 2000 patient study. [2022]

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

Steroid-free emollient formulations reduce symptoms of eczema and improve quality of life. [2014]

10. India pubmed.ncbi.nlm.nih.gov

Pimecrolimus: a review of pre-clinical and clinical data. [2014]