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

NCT03868098 | Completed Phase 4

• 1 other identifier: Inno-6049
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• Total Signs Score (TSS)

  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).

  Baseline, Day 15

Secondary Outcomes (2)

• Total Signs Score (TSS)

  Baseline, Day 8, Day 15

• Target Area Assessment (TAA)

  Change from baseline in TAA at Day 8 and Day 15.

Study Arms (2)

Crisaborole 2% (application rate A, B, C)

ACTIVE COMPARATOR

Crisaborole (Marketed drug)

Drug: Crisaborole 2%

Placebo ointment (vehicle)

PLACEBO COMPARATOR

Placebo

Drug: Placebo ointment

Interventions

Crisaborole 2% DRUG

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

Also known as: Eucrisa

Crisaborole 2% (application rate A, B, C)

Placebo ointment DRUG

Placebo ointment (vehicle)

Placebo ointment (vehicle)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovaderm Research Inc.: lead

Study Sites (1)

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

crisaborole

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Robert Bissonnette, MD

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intra-individual

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 8, 2019
• Study Start: May 21, 2019
• Primary Completion: November 25, 2020
• Study Completion: November 25, 2020
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)