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

NCT04008784 | Completed FDA Drug

• 1 other identifier: CRCC-2019-001
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Investigator Global Assessment

  2 grade or greater improvement from baseline

  Week 8

Secondary Outcomes (1)

• Improvement in Patient Itching

  Week 8

Study Arms (2)

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]

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]; Drug: Triamcinolone Acetonide 0.1% Ointment

Interventions

Crisaborole 2% Topical Application Ointment [EUCRISA] DRUG

Ointment

Crisaborole 2% Topical Application Ointment [EUCRISA]; Crisaborole 2% plus Triamcinolone Acetonide 0.1%Ointment

Triamcinolone Acetonide 0.1% Ointment DRUG

Topical Corticosteroid

Crisaborole 2% plus Triamcinolone Acetonide 0.1%Ointment

Eligibility Criteria

• Age: 2 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinical Research Center of the Carolinas: lead
• Pfizer: collaborator

Study Sites (1)

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

Related Publications (3)

• 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.

  PMID: 26377142 BACKGROUND

• 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.

  PMID: 29033598 BACKGROUND

• PL McCormack - American journal of clinical dermatology, 2011 - Springer

  BACKGROUND

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

crisaborole; Triamcinolone Acetonide; Ointments

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Todd Schlesinger, MD

  Clinical Research Center of the Carolinas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 5, 2019
• Study Start: September 16, 2019
• Primary Completion: July 14, 2020
• Study Completion: September 8, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)