Comparison of Skin Thickness Under Treatment With Pimecro... | NCT00655512

Studies
Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream, Hydrocortisonacetat 1% Cream, Betamethasonvalerat 0,1% Cream and Clobetasol-17-propionat 0,05% Cream Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound

NCT00655512

Sponsor

Technische Universität Dresden

Status

Completed

Last Update Posted

Jun 11, 2014Estimated

Enrollment

40Actual

Phase

Phase 1

Conditions

Healthy

Interventions

pimecrolimus 1% cream
hydrocortisonacetat 1% cream
betamethasonvalerat 0,1% cream
clobetasol-17-propionat 0,05% cream
Placebo

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

Official Title

Comparison of Skin Thickness Under Treatment With Pimecrolimus 1% Cream (Elidel® 1% Cream), Hydrocortisonacetat 1% Cream (Hydrogalen® Cream), Betamethasonvalerat 0,1% Cream (Betagalen® Cream) and Clobetasol-17-propionat 0,05% Cream (Clobegalen® Cream) Assessed by Optical Coherence Tomography (OCT) and 20-MHZ Ultrasound - a Single Blind, Placebo-controlled, Randomized, Monocenter Clinical Trial

Status Module

Record Verification Date

Jun 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

Jan 2008

Primary Completion Date

Jun 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Apr 4, 2008

First Submission Date that Met QC Criteria

Apr 9, 2008

First Posted Date

Apr 10, 2008Estimated

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

Jun 10, 2014

Last Update Posted Date

Jun 11, 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

Description Module

Brief Summary

to compare the atrophogenic potentials of pimecrolimus 1% cream, hydrocortisonacetat 1% cream, betamethasonvalerat 0,1% cream and clobetasol-17-Propionat 0,05% cream

Detailed Description

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 1

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
1	Active Comparator	Drug: hydrocortisonacetat 1% cream Drug: betamethasonvalerat 0,1% cream Drug: clobetasol-17-propionat 0,05% cream
2	Active Comparator	Drug: pimecrolimus 1% cream Drug: betamethasonvalerat 0,1% cream Drug: clobetasol-17-propionat 0,05% cream
3	Active Comparator	Drug: pimecrolimus 1% cream Drug: hydrocortisonacetat 1% cream Drug: clobetasol-17-propionat 0,05% cream
4	Active Comparator	Drug: pimecrolimus 1% cream Drug: hydrocortisonacetat 1% cream Drug: betamethasonvalerat 0,1% cream
5	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pimecrolimus 1% cream	Drug	twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks	2 3 4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
thickness of epidermis		9 times in 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
atrophogenic effect assessed by dermaphot		9 times in 4 weeks
moisture of skin assessed by corneometer		9 times in 4 weeks
transpire of skin assessed by tewameter

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male and female probands age between 18-40 years
skin healthy
skintype I-III according to Fitzpatrick

Exclusion Criteria:

women of childbearing potential without adequate contraception
pregnant or breastfeeding
genetic defect of epidermal barrier
external or systemic treatment with drugs, which probably have an effect to the thickness of skin or to the production of teleangiektasien within the last 6 month before study entry
skin disease, which hinder the evaluation with OCT, ultrasound or dermaphot
UV treatment within the last 4 weeks before study entry
participation to another clinical trial within the last 30 days before study entry
allergy against pimecrolimus or hydrocortison or betamethasonvalerat or Clobetasol-17-propionat
severe systemic diseases; ongoing immunosuppressive treatment
planned vaccination should realize before study entry or 28 days after end of treatment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roland Aschoff, MD	Department of Dermatology, Medical Faculty, Technical University Dresden, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology, Medical Faculty, TU Dresden		Dresden			Germany

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms