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Completed

NCT Number: NCT01948869

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

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

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Münster, North Rhine-Westphalia, 48155, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phoenix II (BAY81-2996)

Device

Phoenix I (BAY81-2996)

Device

Primary outcomes

  1. 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 outcomes

  1. Number of subjects with abnormal vital signs

    Time frame: Up to 10 weeks

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

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

    Time frame: Up to 10 weeks

  3. Erythema by means of chromametry

    Time frame: Up to 29 days

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

    Time frame: Up to 29 days

  5. Skin hydration by means of corneometry

    Time frame: Up to 29 days

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

    Time frame: Up to 29 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: Phoenix II

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 24, 2013
Registry last updated
Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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