ABOUT THIS STUDY
- 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.
- 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
- 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
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