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

Dermatitis, Atopic Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn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• Status: Withdrawn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• Status: Withdrawn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

• Dermatitis
• Dermatitis, Atopic
• Eczema

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

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.