NCT04008784

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: Clinical Research Center of the Carolinas · Academic / Other
• Sex: All
• Age: 2 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Crisaborole 2% Topical Application Ointment [EUCRISA]	Ointment
DRUG	Triamcinolone Acetonide 0.1% Ointment	Topical Corticosteroid

Timeline

• Start date: 2019-09-16
• Primary completion: 2020-07-14
• Completion: 2020-09-08
• First posted: 2019-07-05
• Last updated: 2021-04-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study