check_circleStudy Completed

Atopic dermatitis

Bayer Identifier:

13932

ClinicalTrials.gov Identifier:

NCT00980135

EudraCT Number:

2008-008136-82

EU CT Number:

Not Available
Sinecort pilot efficacy study

Trial purpose

The study shall prove whether treatment of atopic dermatitis is equally effective with Sinecort cream as compared to standard therapy (Hydrocortisone cream).

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • - Male or female Caucasians aged between 18 and 65 years
    - Patients with mild AD presenting a scoring AD (SCORAD) rating between 3-25
    - Skin type I - IV according to Fitzpatrick
    - Acute AD symptoms on each assessment areas (local SCORAD >/=3 and <= 12)
    - Acute symptom of pruritus at Baseline
  • - 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, 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
40
Trial Dates
November 2009 - May 2010
Phase
Phase 2
Could I Receive a placebo
No
Products
Dexpanthenol (BAY81-2996)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Münster, 48155, Germany

Primary Outcome

  • Efficacy rate versus comparator and untreated skin
    date_rangeTime Frame:
    After 29 days of twice daily applications
    enhanced_encryption
    Safety Issue:
    no
  • Local side effects on the skin
    date_rangeTime Frame:
    29 days
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Local SCORAD as clinical assessment by means of the intensity items of the SCORAD index) at Visit 2 through Visit 6
    date_rangeTime Frame:
    after 29 days
    enhanced_encryption
    Safety Issue:
    no
  • Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6
    date_rangeTime Frame:
    after 29 days
    enhanced_encryption
    Safety Issue:
    no
  • Skin hydration by means of corneometry at visit 2 through visit 6
    date_rangeTime Frame:
    after 29 days
    enhanced_encryption
    Safety Issue:
    no
  • Erythema by means of chromametry at Visit 2 through Visit 6
    date_rangeTime Frame:
    after 29 days
    enhanced_encryption
    Safety Issue:
    no
  • Intensity of pruritus at each day of the dosing period (day 1- day 29) as reported in the patients diary and at Visit 2 through Vist 6 by means of visual analogue scale (VAS)
    date_rangeTime Frame:
    after 29 days
    enhanced_encryption
    Safety Issue:
    yes
  • Incidence and severity of Adverse Event
    date_rangeTime Frame:
    visit 2 (start of dosing period) till 6 weeks after end of treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Vital signs
    date_rangeTime Frame:
    visit1 and 6 weeks after end of treatment
    enhanced_encryption
    Safety Issue:
    yes
  • Local side effects
    date_rangeTime Frame:
    visit 2 (start of dosing period) till 6 weeks after end of treatment
    enhanced_encryption
    Safety Issue:
    yes

Trial design

An investigator-blind, randomized, monocentre, 3-arm, active controlled pilot trial to explore the efficacy and safety of a new topical medical device in patients with mild atopic dermatitis in an intra-individual comparison with a standard therapy (1% Hydrocortisone cream) and untreated skin.
Trial Type
Interventional
Intervention Type
Device
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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.Click here to find results for studies related to Bayer Healthcare products.