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

NCT ID: NCT00655512

Last Updated: 2014-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type ACTIVE_COMPARATOR

hydrocortisonacetat 1% cream

Intervention Type DRUG

twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

betamethasonvalerat 0,1% cream

Intervention Type DRUG

twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks

clobetasol-17-propionat 0,05% cream

Intervention Type DRUG

twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks

2

Group Type ACTIVE_COMPARATOR

pimecrolimus 1% cream

Intervention Type DRUG

twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

betamethasonvalerat 0,1% cream

Intervention Type DRUG

twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks

clobetasol-17-propionat 0,05% cream

Intervention Type DRUG

twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks

3

Group Type ACTIVE_COMPARATOR

pimecrolimus 1% cream

Intervention Type DRUG

twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

hydrocortisonacetat 1% cream

Intervention Type DRUG

twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

clobetasol-17-propionat 0,05% cream

Intervention Type DRUG

twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks

4

Group Type ACTIVE_COMPARATOR

pimecrolimus 1% cream

Intervention Type DRUG

twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

hydrocortisonacetat 1% cream

Intervention Type DRUG

twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

betamethasonvalerat 0,1% cream

Intervention Type DRUG

twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks

5

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pimecrolimus 1% cream

twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

Intervention Type DRUG

hydrocortisonacetat 1% cream

twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

Intervention Type DRUG

betamethasonvalerat 0,1% cream

twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks

Intervention Type DRUG

clobetasol-17-propionat 0,05% cream

twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks

Intervention Type DRUG

Placebo

twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Elidel 1% cream Hydrogalen cream Betagalen cream Clobegalen cream

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Roland Aschoff, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Medical Faculty, Technical University Dresden, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Dermatology, Medical Faculty, TU Dresden

Dresden, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TUD-OCT011-023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.