Sinecort Pilot Efficacy Study | NCT00980135

Studies
Sinecort Pilot Efficacy Study

NCT00980135

Sponsor

Bayer

Status

Completed

Last Update Posted

Apr 2, 2014Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Atopic Dermatitis

Interventions

Sinecort cream
Hydrocortison cream
Untreated skin

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-008136-82	EudraCT Number

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Sep 16, 2009

First Submission Date that Met QC Criteria

Sep 17, 2009

First Posted Date

Sep 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2014

Last Update Posted Date

Apr 2, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Arm 1	Experimental	Device: Sinecort cream
Arm 2	Experimental	Drug: Hydrocortison cream
Arm 3	Other	Other: Untreated skin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sinecort cream	Device	Application over 29 days	Arm 1
Hydrocortison cream

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy rate versus comparator and untreated skin		After 29 days of twice daily applications
Local side effects on the skin		29 days

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Münster	North Rhine-Westphalia	48155	Germany

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided