NCT00980135

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

April 2, 2014

Status Verified

April 1, 2014

Enrollment Period

6 months

First QC Date

September 16, 2009

Last Update Submit

March 31, 2014

Conditions

Atopic Dermatitis

Keywords

SinecortHydrocortisonMild atopic dermatitisEfficacy, safety

Outcome Measures

Primary Outcomes (2)

  • Efficacy rate versus comparator and untreated skin

    After 29 days of twice daily applications

  • Local side effects on the skin

    29 days

Secondary Outcomes (8)

  • Local SCORAD as clinical assessment by means of the intensity items of the SCORAD index) at Visit 2 through Visit 6

    after 29 days

  • Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6

    after 29 days

  • Skin hydration by means of corneometry at visit 2 through visit 6

    after 29 days

  • Erythema by means of chromametry at Visit 2 through Visit 6

    after 29 days

  • 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)

    after 29 days

  • +3 more secondary outcomes

Study Arms (3)

Arm 1

EXPERIMENTAL
Device: Sinecort cream

Arm 2

EXPERIMENTAL
Drug: Hydrocortison cream

Arm 3

OTHER
Other: Untreated skin

Interventions

Sinecort creamDEVICE

Application over 29 days

Arm 1
Hydrocortison creamDRUG

Application over 29 days

Arm 2
Untreated skinOTHER
Arm 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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, 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Münster, North Rhine-Westphalia, 48155, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2009

First Posted

September 18, 2009

Study Start

November 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

April 2, 2014

Record last verified: 2014-04

Locations

DE(1)