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

NCT01948869 | Completed

• 2 other identifiers: 169602013-002569-20
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Atopic

Keywords

Phoenix; Mild atopic dermatitis; efficacy; safety

Outcome Measures

Primary Outcomes (1)

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

  Up to 29 days

Secondary Outcomes (6)

• Number of subjects with abnormal vital signs

  Up to 10 weeks

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

  Up to 10 weeks

• Erythema by means of chromametry

  Up to 29 days

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

  Up to 29 days

• Skin hydration by means of corneometry

  Up to 29 days

Study Arms (3)

Phoenix II

EXPERIMENTAL

Application over 29 days twice daily

Device: Phoenix II (BAY81-2996)

Phoenix I

ACTIVE COMPARATOR

Application over 29 days twice daily

Device: Phoenix I (BAY81-2996)

Untreated skin

NO INTERVENTION

Untreated skin areas of subjects will be observed over 29 days

Interventions

Phoenix II (BAY81-2996) DEVICE

Phoenix II

Phoenix I (BAY81-2996) DEVICE

Phoenix I

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Münster, North Rhine-Westphalia, 48155, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: September 24, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 7, 2014

Record last verified: 2014-08

Locations

DE (1)