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Trial record 65 of 154 for:    Dermatitis, Atopic, 8

Different Application Rates of Crisaborole Ointment 2% in Adults With Mild to Moderate Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03868098
Recruitment Status : Recruiting
First Posted : March 8, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Innovaderm Research Inc.

Brief Summary:
This study is being conducted to evaluate the efficacy and safety of 3 different application rates of topically applied Crisaborole ointment 2% over vehicle in adults with mild to moderate atopic dermatitis (AD). In each subject four application areas will be identified. Each subject will receive 4 treatments: the 3 different application rates of the active treatment and the vehicle. The areas will be randomly assigned to treatment with topical Crisaborole ointment 2% and vehicle, once daily, for 2 weeks, without occlusion.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: Crisaborole 2% Drug: Placebo ointment Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intra-individual
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Intra-Individual, Vehicle‑Controlled Study to Evaluate the Efficacy and Safety of Different Application Rates of Topically Applied Crisaborole Ointment 2% in Adult Subjects With Mild to Moderate Atopic Dermatitis
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Crisaborole

Arm Intervention/treatment
Active Comparator: Crisaborole 2% (application rate A, B, C)
Crisaborole (Marketed drug)
Drug: Crisaborole 2%
Crisaborole ointment 2% (application rate A, B, C) for 15 days (double blind)
Other Name: Eucrisa

Placebo Comparator: Placebo ointment (vehicle)
Placebo
Drug: Placebo ointment
Placebo ointment (vehicle)




Primary Outcome Measures :
  1. Total Signs Score (TSS) [ Time Frame: Baseline, Day 15 ]

    Change from baseline in TSS in target lesions treated with crisaborole ointment 2% or vehicle at Day 15.

    Total Signs Score (TSS) of the lesion is the assessment of the severity of erythema, edema/papulation, excoriation, and lichenification. Each of these subscales is scored independently using the 4-point severity scale with a value range from 0 to 3; 0 is the minimum (best) and 3 is the maximum (worst). The total score is computed by the sum of each subscale where the total ranges from the minimum 0 (best) to the maximum 12 (worst).



Secondary Outcome Measures :
  1. Total Signs Score (TSS) [ Time Frame: Baseline, Day 8, Day 15 ]

    Change from baseline in lesion severity as measured by TSS at Day 8 and Day 15

    Total Signs Score (TSS) of the lesion is the assessment of the severity of erythema, edema/papulation, excoriation, and lichenification. Each of these subscales is scored independently using the 4-point severity scale with a value range from 0 to 3; 0 is the minimum (best) and 3 is the maximum (worst). The total score is computed by the sum of each subscale where the total ranges from the minimum 0 (best) to the maximum 12 (worst).


  2. Target Area Assessment (TAA) [ Time Frame: Change from baseline in TAA at Day 8 and Day 15. ]
    Change from baseline in TAA at Day 8 and Day 15



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of active atopic dermatitis (AD) with at least 6 month history prior to screening and that has been clinically stable for 1 month.
  • Has four application areas of 3 cm in diameter with a TSS of ≥5 and TAA of moderate at Day 1. The application areas must not be located on the face, scalp, axillae, groin, genitals, hands, and feet. The application areas should be ≥1 cm apart.

Exclusion Criteria:

  • Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
  • Subject has clinically infected AD.
  • Subject has a Fitzpatrick's Skin Phototype ≥5.
  • Subject is known to have immune deficiency or is immunocompromised.
  • Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or successfully treated localized carcinoma in situ of the cervix are not to be excluded.
  • Subject had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
  • Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
  • Subject has a known history of chronic infectious disease (eg, hepatitis B, hepatitis C, or infection with human immunodeficiency virus).
  • Subject with a known lack of efficacy to crisaborole.
  • Subject has a known or suspected allergy to crisaborole, including any non-medicinal ingredient, or component of the container.
  • Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868098


Contacts
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Contact: Ana Palijan 514-521-4285 ext 259 apalijan@innovaderm.ca

Locations
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Canada, Quebec
Innovaderm Research Inc. Recruiting
Montréal, Quebec, Canada, H2K 4L5
Contact: Ana Palijan, Ph.D.    514-521-4285 ext 259    apalijan@innovaderm.ca   
Contact: Audrey Fortier, M.Sc.    514-521-4285 ext 384    afortier@innovaderm.ca   
Principal Investigator: Robert Bissonnette, MD         
Sponsors and Collaborators
Innovaderm Research Inc.
Investigators
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Principal Investigator: Robert Bissonnette, MD Medical Director

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Responsible Party: Innovaderm Research Inc.
ClinicalTrials.gov Identifier: NCT03868098     History of Changes
Other Study ID Numbers: Inno-6049
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases