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Completed

NCT Number: NCT03868098

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Crisaborole 2%

Drug

Crisaborole ointment 2% (application rate A, B, C) for 15 days (double blind)

Other names: Eucrisa

Placebo Ointment

Drug

Placebo ointment (vehicle)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Innovaderm Research Inc.

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2019
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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