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Phosphodiesterase-4 (PDE-4) Inhibitor

Crisaborole for Eczema

Q: Is the age of eligibility for this trail restricted to adults above 25 years old?

This research is accepting participants aged between 2 and 17 years.

Q: Are there any remaining opportunities for patients to join this clinical trial?

Affirmative. The information published on clinicaltrials.gov confirms that this trial is actively recruiting, having been posted on December 17th 2019 and recently updated on June 28th 2022. 60 subjects are required from a single medical site.

Q: What are the criteria for enrolment in this experiment?

A maximum of 60 minors between the ages 2-17 are able to participate in this study, provided they also meet other eligibility criteria. These include having a mild or moderate form of <a href="https://www.withpower.com/clinical-trials/eczema">eczema</a> as judged on the Investigator's Global Assessment scale (IGA) which ranges 0-4 with higher numbers indicating greater severity.

Q: What potential risks do patients face when using Crisaborole?

There is ample evidence supporting crisaborole's safety, resulting in this medication being allocated a score of 3.

Q: How many participants are currently being recruited for this clinical trial?

Yes, according to the information hosted on clinicaltrials.gov, this trial is actively recruiting patients and was first posted in December 2019 with a most recent update of June 2022. Around 60 participants are needed from one medical centre.

Q: What ailments are regularly treated with Crisaborole?

Crisaborole is the most common treatment for synovitis, but has been clinically proven to also treat ophthalmia, sympathetic disorders, skin inflammations and dermabrasion.

Q: What prior experimentation has been done using Crisaborole?

Presently, a total of 106 trials are underway exploring the potential benefits of Crisaborole. Of these investigations, 29 have advanced to Phase 3. While most studies for crisaborole originate in <a href="https://www.withpower.com/clinical-trials/boston-ma">Boston ma</a>, there are over 3000 locations globally conducting research into this treatment option.

Q: What is the primary goal of this experiment?

This clinical trial's chief objective is to measure the frequency of steroid usage over a 90-day period. Secondary goals comprise assessing severity of itching by Pruritus score (0 - 10, 0 meaning no itch and 10 representing unbearable irritation), Quality of Life for participants with Children's Dermatology Life Quality Index (0 - 30, higher numbers signifying greater impairment) and finally determining the impact on family members through Dermatitis Family Impact Questionnaire (0 -30; again, higher scores indicating more severe consequences).

Phase 4

Waitlist Available

Led By Anna Grossberg, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children aged 2 or older (<18)

Diagnosed with atopic dermatitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 90

Awards & highlights

Study Summary

This trial will test whether crisaborole can help kids with eczema by reducing their need for topical steroids.

Who is the study for?

This trial is for children aged 2 or older diagnosed with mild to moderate atopic dermatitis, as measured by a specific scale. Children must not have allergies to any ingredients in the treatments being tested and should be able to follow study instructions. Those with severe eczema or other medical issues that could interfere, pregnant or lactating females, and participants in another research study cannot join.Check my eligibility

What is being tested?

The trial is testing whether Crisaborole can reduce the need for steroid creams like Triamcinolone and Hydrocortisone in treating children's eczema. It compares the effectiveness of Crisaborole against these common steroid-based ointments and includes Aquaphor as part of skin care routine.See study design

What are the potential side effects?

Crisaborole may cause side effects such as burning or stinging at the application site. Steroid ointments like Triamcinolone and Hydrocortisone might lead to skin thinning, discoloration, increased risk of infections, or hormonal imbalances if used long-term.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 2 and 17 years old.

Select...

I have been diagnosed with eczema.

Select...

My Alzheimer's disease is mild to moderate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Steroid refills

Steroid usage frequency

Steroids

Secondary outcome measures

Eczema severity as assessed by SCORing Atopic Dermatitis (SCORAD) score

Eczema

Dermatitis

+3 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: CrisaboroleActive Control4 Interventions

Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.

Group II: ControlPlacebo Group3 Interventions

Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.

Group III: VehiclePlacebo Group3 Interventions

Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor

4,565 Previous Clinical Trials

10,908,067 Total Patients Enrolled

Johns Hopkins UniversityLead Sponsor

2,247 Previous Clinical Trials

14,816,794 Total Patients Enrolled

Anna Grossberg, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Crisaborole (Phosphodiesterase-4 (PDE-4) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03832010 — Phase 4

Atopic Dermatitis Research Study Groups: Control, Vehicle, Crisaborole

Atopic Dermatitis Clinical Trial 2023: Crisaborole Highlights & Side Effects. Trial Name: NCT03832010 — Phase 4

Crisaborole (Phosphodiesterase-4 (PDE-4) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03832010 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age of eligibility for this trail restricted to adults above 25 years old?

"This research is accepting participants aged between 2 and 17 years."

Answered by AI

Are there any remaining opportunities for patients to join this clinical trial?

"Affirmative. The information published on clinicaltrials.gov confirms that this trial is actively recruiting, having been posted on December 17th 2019 and recently updated on June 28th 2022. 60 subjects are required from a single medical site."

Answered by AI

What are the criteria for enrolment in this experiment?

"A maximum of 60 minors between the ages 2-17 are able to participate in this study, provided they also meet other eligibility criteria. These include having a mild or moderate form of eczema as judged on the Investigator's Global Assessment scale (IGA) which ranges 0-4 with higher numbers indicating greater severity."

Answered by AI

What potential risks do patients face when using Crisaborole?

"There is ample evidence supporting crisaborole's safety, resulting in this medication being allocated a score of 3."

Answered by AI

How many participants are currently being recruited for this clinical trial?

"Yes, according to the information hosted on clinicaltrials.gov, this trial is actively recruiting patients and was first posted in December 2019 with a most recent update of June 2022. Around 60 participants are needed from one medical centre."

Answered by AI

What ailments are regularly treated with Crisaborole?

"Crisaborole is the most common treatment for synovitis, but has been clinically proven to also treat ophthalmia, sympathetic disorders, skin inflammations and dermabrasion."

Answered by AI

What prior experimentation has been done using Crisaborole?

"Presently, a total of 106 trials are underway exploring the potential benefits of Crisaborole. Of these investigations, 29 have advanced to Phase 3. While most studies for crisaborole originate in Boston ma, there are over 3000 locations globally conducting research into this treatment option."

Answered by AI

What is the primary goal of this experiment?

"This clinical trial's chief objective is to measure the frequency of steroid usage over a 90-day period. Secondary goals comprise assessing severity of itching by Pruritus score (0 - 10, 0 meaning no itch and 10 representing unbearable irritation), Quality of Life for participants with Children's Dermatology Life Quality Index (0 - 30, higher numbers signifying greater impairment) and finally determining the impact on family members through Dermatitis Family Impact Questionnaire (0 -30; again, higher scores indicating more severe consequences)."

Answered by AI

Recent research and studies

Journal of the American Academy of DermatologyJournal

Efficacy and Safety of Crisaborole Ointment, a Novel, Nonsteroidal Phosphodiesterase 4 (PDE4) Inhibitor for the Topical Treatment of Atopic Dermatitis (AD) in Children and Adults

Paller, Amy S., Wynnis L. Tom, Mark G. Lebwohl, Robin L. Blumenthal, Mark Boguniewicz, Robert S. Call, Lawrence F. Eichenfield, et al.. 2016. “Efficacy and Safety of Crisaborole Ointment, a Novel, Nonsteroidal Phosphodiesterase 4 (PDE4) Inhibitor for the Topical Treatment of Atopic Dermatitis (AD) in Children and Adults”. Journal of the American Academy of Dermatology. Elsevier BV. doi:10.1016/j.jaad.2016.05.046.

Journal of the American Academy of DermatologyJournal

Guidelines of Care for the Management of Atopic Dermatitis

Eichenfield, Lawrence F., Wynnis L. Tom, Timothy G. Berger, Alfons Krol, Amy S. Paller, Kathryn Schwarzenberger, James N. Bergman, et al.. 2014. “Guidelines of Care for the Management of Atopic Dermatitis”. Journal of the American Academy of Dermatology. Elsevier BV. doi:10.1016/j.jaad.2014.03.023.

clinicaltrials.govStudy

Steroid-reducing Effects of Crisaborole

2019. "Steroid-reducing Effects of Crisaborole". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03832010.

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