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Atopic DermatitisNCT04008784

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

An observational study of Atopic Dermatitis, run by Clinical Research Center of the Carolinas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 2 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis
What is being tested?
Crisaborole 2% Topical Application Ointment [EUCRISA] and Triamcinolone Acetonide 0.1% Ointment
How many people
16 participants
Where
1 siteUnited States
Study dates
16 Sep 2019to 8 Sep 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical Research Center of the Carolinas

    Charleston, South Carolina, 29407

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Crisaborole 2% Topical Application Ointment [EUCRISA], Triamcinolone Acetonide 0.1% Ointment
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Crisaborole 2% Topical Application Ointment [EUCRISA]Drug

    Ointment

  • Triamcinolone Acetonide 0.1% OintmentDrug

    Topical Corticosteroid

Study groups in NCT04008784
Study groupRoleWhat they receive
Crisaborole 2% Topical Application Ointment [EUCRISA]Crisaborole 2% Topical Application Ointment [EUCRISA] applied twice a day for 8 weeks
Receives: Drug: Crisaborole 2% Topical Application Ointment [EUCRISA]
Crisaborole 2% plus Triamcinolone Acetonide 0.1%OintmentCrisaborole 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
Receives: Drug: Crisaborole 2% Topical Application Ointment [EUCRISA]; Drug: Triamcinolone Acetonide 0.1% Ointment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigator Global Assessment

    2 grade or greater improvement from baseline

    Measured: Week 8

Secondary outcomes (1)

  1. Improvement in Patient Itching

    Visual Analog Scale (1-10) for Itching improvement

    Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start16 Sep 2019
  3. Primary completion14 Jul 2020
  4. Study completion8 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04008784
Sponsor's protocol ID
CRCC-2019-001
Status last verified
Apr 2021
First submitted
26 Jun 2019
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 26377142

  • 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.

    PubMed 29033598

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

Questions about this trial

What is this clinical trial studying?

An observational study of Atopic Dermatitis, run by Clinical Research Center of the Carolinas at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator Global Assessment (time frame: Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04008784, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.

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