Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis

NCT01469767 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB00018876
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy of short-term treatment with fluocinonide cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD).

Conditions

Atopic Dermatitis

Keywords

eczema; itch; scratching; actigraphy; adherence

Outcome Measures

Primary Outcomes (1)

• IGA

  Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease

  14 days

Secondary Outcomes (4)

• Actigraphy

  14 days

• EASI

  14 days

• BSA

  14 days

• VAS

  14 days

Study Arms (1)

Fluocinonide cream

EXPERIMENTAL

Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.

Drug: Fluocinonide cream

Interventions

Fluocinonide cream DRUG

Fluocinonide cream 0.1% applied twice daily for 5 days.

Also known as: Vanos

Fluocinonide cream

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female with mild to severe atopic dermatitis, 12 years of age or older, that agree to participate and provide written consent (parent permission and assent if applicable).
• Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 through 4 in the Investigator Global Assessment).
• Visual Analog Scale of Itch score at Baseline must be greater than or equal to 50 on a 100-point scale.
• Percentage of overall body surface area of involvement (BSA) must be ≥2%.
• Women of childbearing potential will be allowed to participate in the study, and will be required to use at least one form of birth control.

You may not qualify if:

• Use within four weeks from Baseline any systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids.
• Application or use within two weeks of Baseline topical corticosteroid medications or topical anti-inflammatory medication, which may influence study outcome.
• Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
• Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study.
• Use of anti-histamines while participating in the study will not be permitted unless the subject meets criteria for anti-histamine use on the VAS scale. Additionally, the subject must remain on a stable dose of anti-histamine throughout the study period. If a patient meets such criteria for anti-histamine use, this will be noted in the subject's chart.
• Amount of disease involvement that would require \>60 gm of cream in a 1 week period.
• Subjects with known allergy or sensitivity to topical Vanos® cream or components.
• Pregnant women
• Women who are breastfeeding

Sponsors & Collaborators

• Wake Forest University: lead
• Medicis Pharmaceutical Corporation: collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Pruritus

Interventions

Fluocinonide

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; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluocinolone Acetonide; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Steve Feldman MD
• Organization: Wake Forest University Health Sciences

sfeldman@wakehealth.edu

336-716=3775

Study Officials

• Steven R Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 10, 2011
• Study Start: February 1, 2012
• Primary Completion: August 17, 2013
• Study Completion: August 17, 2013
• Last Updated: September 7, 2018
• Results First Posted: May 1, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)