Trial Outcomes & Findings for A Study to Determine Serum and Skin Biopsy Biomarkers in Patients Receiving Topical Corticosteroid (TCS) and Following TCS Withdrawal (NCT NCT02317276)

Last Updated: 2019-01-24

Results Overview

The blood and skin biomarkers to be evaluated include but are not limited to eosinophils, Immunoglobulin E (IgE), Interleukin 13 (IL-13), Chemokine ligand 13 (CCL-13), and Chemokine ligand 17 (CCL-17). These biomarkers will be evaluated for differential gene expression and protein levels in samples obtained from atopic dermatitis patients on and off topical corticosteroid treatment.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

Baseline to Week 8

Results posted on

2019-01-24

Participant Flow

For this study we recruited participants from UCSF Dermatology Clinic, and by posting advertisements online

There was a washout period prior to screening for those patients who have previously received the following medications: 1. Cyclosporine/Oral Steroids/Imuran/Mycophenolate Mofetil/Other systemic immunosuppressants: 4 weeks 2. Phototherapy: 4 weeks 3. Biologics: 5 half lives of the drug

Participant milestones

Participant milestones
Measure	Treatment Topical Triamcinolone 0.1% ointment will be provided for twice daily application, during treatment periods. Triamcinolone 0.1%: Topical ointment
Overall Study STARTED	11
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Determine Serum and Skin Biopsy Biomarkers in Patients Receiving Topical Corticosteroid (TCS) and Following TCS Withdrawal

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=11 Participants Topical Triamcinolone 0.1% ointment will be provided for twice daily application, during treatment periods. Triamcinolone 0.1%: Topical ointment
Age, Continuous	32 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Eczema Area and Severity Index (EASI)	19.7 scores on a scale STANDARD_DEVIATION 6.7 • n=5 Participants
Investigator's Global Assessment (IGA)	3.1 scores on a scale STANDARD_DEVIATION 0.3 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 8

Population: No samples were analyzed for the primary outcome measure of change in blood and tissue levels. Since the study was terminated, the blood and tissue samples were not analyzed as planned.

Outcome measures

Outcome data not reported

Adverse Events

Treatment

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

Sarah Arron, MD, PhD

UCSF Dermatology

Phone: 415-353-9684

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place