Study Completed

Dermatitis, Atopic

Bayer Identifier:

16960

ClinicalTrials.gov Identifier:

NCT01948869

EudraCT Number:

2013-002569-20

EU CT Number:

Not Available

Efficacy/Safety study to explore a new revised topical formulation in Atopic Dermatitis

Trial purpose

The study shall explore whether treatment of atopic dermatitis is equally effective with respect to a marketed medical device and a new medical device.

Key Participants Requirements

Sex

Both

Age

18 - 60 Years

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 - 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

Trial summary

Enrollment Goal

Trial Dates

October 2013 - June 2014

Phase

n/a

Could I Receive a placebo

Products

Phoenix (Dexpanthenol, BAY81-2996)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	proinnovera GmbH	Münster, 48155, Germany

Primary Outcome

Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index
Time Frame:
Up to 29 days
Safety Issue:
No

Secondary Outcome

Number of subjects with abnormal vital signs
Vital signs consist of blood pressure, heart rate, and body temperature
Time Frame:
Up to 10 weeks
Safety Issue:
Yes
Number of patients with adverse events as a measure of safety and tolerability
Time Frame:
Up to 10 weeks
Safety Issue:
Yes
Erythema by means of chromametry
Time Frame:
Up to 29 days
Safety Issue:
No
Transepidermal water loss (TEWL) as a measure for skin barrier function
Time Frame:
Up to 29 days
Safety Issue:
No
Skin hydration by means of corneometry
Time Frame:
Up to 29 days
Safety Issue:
No
Intensity of pruritus by means of visual analogue scale (VAS)
Time Frame:
Up to 29 days
Safety Issue:
No

Trial design

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

Trial Type

Interventional

Intervention Type

Device

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Single Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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