Study 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

Inclusion Criteria
- 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
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, 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

Trial Dates

November 2009 - May 2010

Phase

Phase 2

Could I Receive a placebo

Products

Dexpanthenol (BAY81-2996)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Münster, 48155, Germany

Primary Outcome

Efficacy rate versus comparator and untreated skin
Time Frame:
After 29 days of twice daily applications
Safety Issue:
no
Local side effects on the skin
Time Frame:
29 days
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
Time Frame:
after 29 days
Safety Issue:
no
Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6
Time Frame:
after 29 days
Safety Issue:
no
Skin hydration by means of corneometry at visit 2 through visit 6
Time Frame:
after 29 days
Safety Issue:
no
Erythema by means of chromametry at Visit 2 through Visit 6
Time Frame:
after 29 days
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)
Time Frame:
after 29 days
Safety Issue:
yes
Incidence and severity of Adverse Event
Time Frame:
visit 2 (start of dosing period) till 6 weeks after end of treatment
Safety Issue:
yes
Vital signs
Time Frame:
visit1 and 6 weeks after end of treatment
Safety Issue:
yes
Local side effects
Time Frame:
visit 2 (start of dosing period) till 6 weeks after end of treatment
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

Additional Information

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