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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01691209
Other study ID # 16200
Secondary ID 2012-001504-38
Status Withdrawn
Phase N/A
First received September 20, 2012
Last updated August 9, 2013
Start date October 2013
Est. completion date June 2014

Study information

Verified date August 2013
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Phoenix (BAY81-2996)
Topical formulation applied to the skin
Drug:
1% Hydrocortison cream
1% Hydrocortison cream applied to the skin

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Local scored atopic dermatitis (SCORAD) as clinical assessment by means of the intensity items of the SCORAD index Up to 29 days No
Other Transepidermal water loss (TEWL) as a measure for skin barrier function Up to 29 days No
Other Skin hydration by means of corneometry Up to 29 days No
Other Erythema by means of chromametry Up to 29 days No
Other Intensity of pruritus by means of visual analogue scale (VAS) Up to 29 days No
Secondary Number of participants with abnormal vital signs Vital signs consist of blood pressure, heart rate and body temperature. Up to 10 weeks Yes
Secondary Number of participants with adverse events as a measure of safety and tolerability Up to 10 weeks Yes
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