Back to results

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

Primary Purpose

Dermatitis, Atopic

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Phoenix II (BAY81-2996)

Phoenix I (BAY81-2996)

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Phoenix, 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 to moderate AD (Atopic Dermatitis) 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 the clinical assessment in the opinion of the investigator
Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment
Regular intake of antiphlogistic drugs (for example, nonsteroidal anti-inflammatory drug [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 II

Phoenix I

Untreated skin

Arm Description

Application over 29 days twice daily

Untreated skin areas of subjects will be observed over 29 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of subjects with abnormal vital signs

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

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

Erythema by means of chromametry

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

Skin hydration by means of corneometry

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

Full Information

NCT ID

NCT01948869

First Posted

September 19, 2013

Last Updated

August 6, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01948869

Brief Title

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

Acronym

Phoenix II

Official Title

An Investigator-blinded, Randomized, Monocentre, 3-arm, Pilot Trial to Compare the Efficacy and Safety of Two Topical Medical Devices in Patients With Mild to Moderate Atopic Dermatitis in an Intra-individual Comparison With Untreated Skin

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

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 respect to a marketed medical device and a new medical device.

6. Conditions and Keywords

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

Dermatitis, Atopic

Keywords

Phoenix, 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

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phoenix II

Arm Type

Experimental

Arm Description

Application over 29 days twice daily

Arm Title

Phoenix I

Arm Type

Active Comparator

Arm Description

Application over 29 days twice daily

Arm Title

Untreated skin

Arm Type

No Intervention

Arm Description

Untreated skin areas of subjects will be observed over 29 days

Intervention Type

Device

Intervention Name(s)

Phoenix II (BAY81-2996)

Intervention Type

Device

Intervention Name(s)

Phoenix I (BAY81-2996)

Primary Outcome Measure Information:

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

Secondary Outcome Measure Information:

Title

Number of subjects 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 patients with adverse events as a measure of safety and tolerability

Time Frame

Up to 10 weeks

Title

Erythema by means of chromametry

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

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 to moderate AD (Atopic Dermatitis) 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 the clinical assessment in the opinion of the investigator Moles, tattoos, strong pigmentation, or scars at the test area that would interfere the clinical assessment Regular intake of antiphlogistic drugs (for example, nonsteroidal anti-inflammatory drug [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 Revised Topical Formulation in Atopic Dermatitis

We'll reach out to this number within 24 hrs