Improvement of Short Term Outcome of Mild to Moderate Atopic Dermatitis Using a Combination of Crisaborole and a Concomitant Topical Corticosteroid Over a 8 Week Period

Improvement of Short Term Outcome of Mild to Moderate Atopic Dermatitis Using a Combination Treatment of Crisaborole Ointment, 2% and a Concomitant Topical Corticosteroid Over a 8 Week Period

This trial is a single-center two arm, open label observational prospective study, that will evaluate the safety and efficacy of crisaborole ointment, 2% alone compared to a combination therapy of crisaborole and a topical corticosteroid (Triamcinolone Acetonide Ointment, 0.1%) over a 8 week period for the treatment of mild to moderate atopic dermatitis.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Crisaborole 2% Topical Application Ointment [EUCRISA]; Drug: Triamcinolone Acetonide 0.1% Ointment

Detailed Description

Male and female subjects, ages 2 to 79 with mild to moderate atopic dermatitis and having an Investigator's Global Assessment Score on a five point scale of 2 or 3 will be enrolled.

Sixteen subjects will be enrolled and randomized 1:1. Eight subjects will be randomized to receive crisaborole alone which will be applied twice daily, once in the morning and once in the evening for 8 weeks. Eight subjects will be randomized to receive a combination therapy of a topical corticosteroid (Triamcinolone Acetonide Ointment, 0.1% and crisaborole ointment, 2% which will be applied twice a day, once in the morning and once in the evening for the first two weeks, followed by crisaborole alone for the following six weeks.

Subjects who meet the inclusion criteria and none of the exclusion criteria at the Screening visit will return to the clinic on Week 0 for Baseline measures and to start treatment which will continue for a period of 8 weeks. Subjects who do not need to undergo a wash-out period may combine the Screening visit and Baseline visit.

Screened subjects requiring a wash-out period (up to 4 weeks) prior to baseline measurements and beginning treatment will attend a total of 4 visits.

Following the Baseline (Week 0) visit, all subjects will report to the clinic for efficacy and safety evaluations at weeks 2, 4 and at the end of study at week 8.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Clinical Research Center of the Carolinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 79 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients age 2 to 79 years of age with confirmed diagnosis of atopic dermatitis

Description

Inclusion Criteria:

• Male and female patients age 2 to 79 years of age with confirmed diagnosis of atopic dermatitis
• Clinical diagnosis of atopic dermatitis that has been clinically stable for ≥1 month
• Total body surface area (BSA) of atopic dermatitis involvement ≤35%, excluding involvement of the scalp.
• Patient or patient's parent(s)/legal representative guardian must be willing and able to apply study medications as directed, comply with study instructions, and commit to attending all visits.
• Females of childbearing potential must use at least one highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use highly effective methods of birth control during the study.
• Patient or patient's parent(s)/legal representative must be capable of giving written informed consent or verbal assent, as applicable, which includes compliance with the requirements and restrictions listed in the consent/assent form; written informed consent must be obtained prior to any study related procedures.

Exclusion Criteria:

• Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period.
• Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation.
• Significant confounding conditions as assessed by study doctor.
• History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
• Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
• Pregnancy or lactation.
• History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or medical monitor, contraindicates their participation.
• Patients with active infection in atopic dermatitis areas requiring antibiotics, antifungals, or antiviral agents within 7 days of Baseline (Day 0).
• Patients with pruritus due to conditions other than atopic dermatitis that, in the opinion of the Investigator, would either interfere with study evaluations or affect the safety of the patient.
• History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to PDE4 inhibitors.
• Use of any prohibited medication. Prohibited concomitant medications, therapy, etc.

during the defined period are as listed below. If a patient requires any of these medications throughout the study period, he/she may be excluded from or discontinued from the study, at the discretion of the Investigator and medical monitor. • From 6 Months prior to the first application of the study drug: Biological products that might have significantly affected the evaluation of atopic dermatitis condition (e.g., tumor necrosis factor [TNF] inhibitors, antiimmunoglobulin [Ig]E antibodies, anti-CD20 antibodies, anti-interleukin [IL]-4 receptor

• From 21 days prior to the first application of study drug: Corticosteroid preparations (oral, injection, and suppository preparations) and topical corticosteroids that were classified as super-high potency (clobetasol propionate).

Oral preparations and injections of immunosuppressants (cyclosporine, methotrexate, azathioprine, tacrolimus, etc.); Excessive sun exposure, tanning booth, other ultraviolet (UV) light source and phototherapy including psoralen and ultraviolet A (PUVA) therapy. • From 14 days prior to the first application of the study drug: any other topical phosphodiesterase 4 (PDE4) inhibitor; Tacrolimus and pimecrolimus cream and/or ointment; Topical corticosteroids that were classified as low, medium, or high potency (e.g., fluocinonide, triamcinolone acetonide, desonide, hydrocortisone).

Eye drops and nasal preparations are allowed.

• From 7 days prior to the first application of the study drug: Oral or intravenous antibiotics, antifungal or antivirus medications Antihistamines/anti-allergics (oral, topical and injections): diphenhydramine, chlorpheniramine maleate, hydroxyzine).

• Visible skin disease or damaged skin at the application site
• Psoriasis and/or active atopic dermatitis/eczema
• Not willing to refrain from using any topical/systemic analgesics such as aspirin
• Pregnant, plan to become pregnant during the study, or are breast-feeding a child
• Using medication which, in the opinion of the investigative personnel, will interfere with the study results, including anti-inflammatory medications
• Any known sensitivity to adhesives;
• Received treatment for any type of internal cancer within 5 years prior to study entry; or have a history of, or are currently being treated for skin cancer;
• Has unstable AD or any consistent requirement for high-potency topical corticosteroids to manage AD signs and symptoms
• Has any clinically significant medical disorder, condition, or disease or clinically significant physical examination finding at Screening that may interfere with study objectives/safety of participants

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Crisaborole 2% Topical Application Ointment [EUCRISA]; Crisaborole 2% Topical Application Ointment [EUCRISA] applied twice a day for 8 weeks	Drug: Crisaborole 2% Topical Application Ointment [EUCRISA]; Ointment
Crisaborole 2% plus Triamcinolone Acetonide 0.1%Ointment; Crisaborole 2% plus Triamcinolone Acetonide 0.1% Ointment applied twice a day for the first 2 weeks, followed by Crisaborole 2% alone applied twice a day for the following 6 weeks	Drug: Crisaborole 2% Topical Application Ointment [EUCRISA]; Ointment; Drug: Triamcinolone Acetonide 0.1% Ointment; Topical Corticosteroid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Global Assessment	2 grade or greater improvement from baseline	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Patient Itching	Visual Analog Scale (1-10) for Itching improvement	Week 8

Collaborators and Investigators

• Sponsor: Clinical Research Center of the Carolinas
• Collaborators: Pfizer
• Investigators: Principal Investigator: Todd Schlesinger, MD, Clinical Research Center of the Carolinas

Publications and helpful links

General Publications

• Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016 Mar 12;387(10023):1109-1122. doi: 10.1016/S0140-6736(15)00149-X. Epub 2015 Sep 13.
• Patel NU, Felix K, Reimer D, Feldman SR. Calcipotriene/betamethasone dipropionate for the treatment of psoriasis vulgaris: an evidence-based review. Clin Cosmet Investig Dermatol. 2017 Sep 29;10:385-391. doi: 10.2147/CCID.S131727. eCollection 2017.
• McCormack PL. Spinosad: in pediculosis capitis. Am J Clin Dermatol. 2011 Oct 1;12(5):349-53. doi: 10.2165/11208070-000000000-00000.

Helpful Links

• NDA 207695 Risk Assessment Review
• NDA 207695 Clinical Review
• Crisaborole FULL PRESCRIPTION INFORMATION

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Actual): July 14, 2020
• Study Completion (Actual): September 8, 2020

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: CRCC-2019-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes