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

Last updated date
Study Location
Clinical Research Center of the Carolinas
Charleston, South Carolina, 29407, United States
Contact
8435568886

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-79 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title 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
Official Title 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
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Male and female patients age 2 to 79 years of age with confirmed diagnosis of atopic dermatitis
Condition Atopic Dermatitis
Intervention
  • Drug: Crisaborole 2% Topical Application Ointment [EUCRISA]
    Ointment
  • Drug: Triamcinolone Acetonide 0.1% Ointment
    Topical Corticosteroid
Study Groups/Cohorts
  • Crisaborole 2% Topical Application Ointment [EUCRISA]
    Crisaborole 2% Topical Application Ointment [EUCRISA] applied twice a day for 8 weeks
    Intervention: 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
    Interventions:
    • Drug: Crisaborole 2% Topical Application Ointment [EUCRISA]
    • Drug: Triamcinolone Acetonide 0.1% Ointment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 3, 2019)
16
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages 2 Years to 79 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Todd Schlesinger, MD8435568886[email protected]
Contact: Diane Pitman[email protected]
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04008784
Other Study ID Numbers CRCC-2019-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD:No
Responsible Party Clinical Research Center of the Carolinas
Study Sponsor Clinical Research Center of the Carolinas
Collaborators Pfizer
Investigators
Principal Investigator:Todd Schlesinger, MDClinical Research Center of the Carolinas
PRS Account Clinical Research Center of the Carolinas
Verification Date July 2019