Back to results

Efficacy/Safety Study to Explore a New Topical Formulation in Atopic Dermatitis (Phoenix)

Primary Purpose

Dermatitis, Atopic

Status

Withdrawn

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Phoenix (BAY81-2996)

1% Hydrocortison cream

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Phoenix, Hydrocortison, mild atopic dermatitis, efficacy, safety

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female Caucasians aged between 18 and 60 years
Patients with mild atopic dermatitis (AD) presenting a scoring AD (SCORAD) rating below 50
Skin type I - IV according to Fitzpatrick
Acute AD symptoms on each assessment areas (local SCORAD ≥ 3 and <= 12) at Baseline
Acute symptom of pruritus at Baseline

Exclusion Criteria:

Any other skin disease at the test area that would interfere with the clinical assessment in the opinion of the investigator
Moles, tattoos, strong pigmentation, or scars at the test area that would interfere with the clinical assessment
Regular intake of antiphlogistic drugs (for example nonsteroidal anti-inflammatory drugs [NSAIDs])
Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas)
UV-therapy or the use of solarium within 30 days before screening as well as during the trial
Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Phoenix

Hydrocortison

Untreated skin

Arm Description

Application over 29 days twice daily

Participants will be observed over 29 days without study treatment

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Number of participants with abnormal vital signs

Vital signs consist of blood pressure, heart rate and body temperature.

Number of participants with adverse events as a measure of safety and tolerability

Full Information

NCT ID

NCT01691209

First Posted

September 20, 2012

Last Updated

August 9, 2013

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01691209

Brief Title

Efficacy/Safety Study to Explore a New Topical Formulation in Atopic Dermatitis

Acronym

Phoenix

Official Title

An Investigator-blinded, Randomized, Monocentre, 3-arm, Active Controlled Pilot Trial to Explore the Efficacy and Safety of a Topical Medical Device in Patients With Mild to Moderate Atopic Dermatitis in an Intra-individual Comparison With a Standard Therapy (1% Hydrocortisone Cream) and Untreated Skin

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Withdrawn

Study Start Date

October 2013 (undefined)

Primary Completion Date

April 2014 (Anticipated)

Study Completion Date

June 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study shall explore whether treatment of atopic dermatitis is equally effective with Phoenix medical device as compared to standard therapy (Hydrocortisone cream).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dermatitis, Atopic

Keywords

Phoenix, Hydrocortison, mild atopic dermatitis, efficacy, safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phoenix

Arm Type

Experimental

Arm Description

Application over 29 days twice daily

Arm Title

Hydrocortison

Arm Type

Active Comparator

Arm Description

Application over 29 days twice daily

Arm Title

Untreated skin

Arm Type

No Intervention

Arm Description

Participants will be observed over 29 days without study treatment

Intervention Type

Device

Intervention Name(s)

Phoenix (BAY81-2996)

Intervention Description

Topical formulation applied to the skin

Intervention Type

Drug

Intervention Name(s)

1% Hydrocortison cream

Intervention Description

1% Hydrocortison cream applied to the skin

Secondary Outcome Measure Information:

Title

Number of participants with abnormal vital signs

Description

Vital signs consist of blood pressure, heart rate and body temperature.

Time Frame

Up to 10 weeks

Title

Number of participants with adverse events as a measure of safety and tolerability

Time Frame

Up to 10 weeks

Other Pre-specified Outcome Measures:

Title

Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index

Time Frame

Up to 29 days

Title

Transepidermal water loss (TEWL) as a measure for skin barrier function

Time Frame

Up to 29 days

Title

Skin hydration by means of corneometry

Time Frame

Up to 29 days

Title

Erythema by means of chromametry

Time Frame

Up to 29 days

Title

Intensity of pruritus by means of visual analogue scale (VAS)

Time Frame

Up to 29 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female Caucasians aged between 18 and 60 years Patients with mild atopic dermatitis (AD) presenting a scoring AD (SCORAD) rating below 50 Skin type I - IV according to Fitzpatrick Acute AD symptoms on each assessment areas (local SCORAD ≥ 3 and <= 12) at Baseline Acute symptom of pruritus at Baseline Exclusion Criteria: Any other skin disease at the test area that would interfere with the clinical assessment in the opinion of the investigator Moles, tattoos, strong pigmentation, or scars at the test area that would interfere with the clinical assessment Regular intake of antiphlogistic drugs (for example nonsteroidal anti-inflammatory drugs [NSAIDs]) Any condition or treatment which might influence the trial (e.g. any treatment with topical antibiotics, antifungals, or corticoids) within 14 days prior to screening as well as during the trial (exception: topical treatment of AD lesions other than the test areas (for example, face) with low potency steroids restricted to small areas) UV-therapy or the use of solarium within 30 days before screening as well as during the trial Any alternative treatment of AD (e.g. acupuncture, kinesiology, and homoeopathy) within 30 days before screening as well as during the trial

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Münster

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

48155

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Efficacy/Safety Study to Explore a New Topical Formulation in Atopic Dermatitis

We'll reach out to this number within 24 hrs