Trial Outcomes & Findings for Reversal of Epidermal Phenotype in Severe Atopic Dermatitis With Cyclosporine Therapy (NCT NCT01149759)

NCT ID: NCT01149759

Last Updated: 2017-03-27

Results Overview

SCORAD ("SCORing Atopic Dermatitis") is a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis (AD) as objectively as possible with scores ranging from 0-100. The higher the score indicates more severe AD. For this outcome the SCORAD change score is computed as an absolute number which is comparing improvement in the SCORAD score of participants at week 12 compared to their SCORAD score at baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2017-03-27

Participant Flow

Participant milestones

Measure	Cyclosporine A 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks. Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reversal of Epidermal Phenotype in Severe Atopic Dermatitis With Cyclosporine Therapy

Baseline characteristics by cohort

Measure	Cyclosporine A n=9 Participants 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks. Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	38 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 9 were included in this analysis from Rockefeller University

SCORAD ("SCORing Atopic Dermatitis") is a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis (AD) as objectively as possible with scores ranging from 0-100. The higher the score indicates more severe AD. For this outcome the SCORAD change score is computed as an absolute number which is comparing improvement in the SCORAD score of participants at week 12 compared to their SCORAD score at baseline.

Outcome measures

Measure	Cyclosporine A n=9 Participants 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks. Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks
SCORAD Change Score	33.34 Change Score Standard Deviation 19.87

SECONDARY outcome

Timeframe: 12 weeks

Population: 9 participants were included in this analysis from Rockefeller University, this is a change in the skin thickness at week 12 compared to baseline

Change in lesional skin epidermal thickness at week 12 compared to baseline

Outcome measures

Measure	Cyclosporine A n=9 Participants 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks. Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks
Change in Epidermal Thickness	79.70 micrometer Standard Deviation 21.18

Adverse Events

Cyclosporine A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Emma Guttman Yassky, MD

Rockefeller University

Phone: 212-327-8333

Email: skhattri@rockefeller.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place