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

Completed

Conditions studied: Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT04008784

Run by

Clinical Research Center of the Carolinas

People needed

16

Starts

2019-09-16

Expected to finish

2020-09-08

Last updated by the study team

2021-04-28

Who can join

Age: 2 and older, up to 79. Sex: any. Healthy volunteers: accepted.

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.
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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