Trial Outcomes & Findings for A Study Evaluating the Efficacy of Fluocinonide Cream 0.1% (Vanos) in Subjects With Atopic Dermatitis (NCT NCT01049243)

Results Overview

Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Baseline to 3 days

Results posted on

2018-08-01

Participant Flow

Participants were enrolled from IRB approved advertising and the Wake Forest University Health Sciences Dermatology Clininc

Participant milestones

Participant milestones
Measure	Vanos Single group; 0.1% Cream, One Application, Twice Daily, 14 Days
Overall Study STARTED	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Evaluating the Efficacy of Fluocinonide Cream 0.1% (Vanos) in Subjects With Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Group n=20 Participants
Age, Continuous	27 years n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	11 Participants n=93 Participants
Region of Enrollment United States	20 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline to 3 days

Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.

Outcome measures

Outcome measures
Measure	Single Group n=20 Participants
Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 2/3.	-0.72 Scores on a scale Standard Deviation 0.57

SECONDARY outcome

Timeframe: Baseline to 14 days

Use of the Investigator's Global Assessment (IGA) score, a subjective scale measuring disease severity. Based on a 6-point scale from 0 (completely clear) to 5 (very severe). Defined score of 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe.

Outcome measures

Outcome measures
Measure	Single Group n=20 Participants
Change in Investigator Global Assessment of Atopic Dermatitis Severity From Baseline to Day 14.	2.4 units on a scale Interval 1.7 to 3.2

Adverse Events

Single Group

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

Steven Feldman, MD, PhD

Wake Forest University Health Sciences

Phone: 336-716-1877

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place