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
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Dresden University of Technology.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Dresden University of Technology
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00655512
First received: April 4, 2008
Last updated: October 29, 2010
Last verified: October 2010
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Purpose
to compare the atrophogenic potentials of pimecrolimus 1% cream, hydrocortisonacetat 1% cream, betamethasonvalerat 0,1% cream and clobetasol-17-Propionat 0,05% cream
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: pimecrolimus 1% cream Drug: hydrocortisonacetat 1% cream Drug: betamethasonvalerat 0,1% cream Drug: clobetasol-17-propionat 0,05% cream Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Dresden University of Technology:
Primary Outcome Measures:
- thickness of epidermis [ Time Frame: 9 times in 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- atrophogenic effect assessed by dermaphot [ Time Frame: 9 times in 4 weeks ] [ Designated as safety issue: No ]
- moisture of skin assessed by corneometer [ Time Frame: 9 times in 4 weeks ] [ Designated as safety issue: No ]
- transpire of skin assessed by tewameter [ Time Frame: 9 times in 4 weeks ] [ Designated as safety issue: No ]
- thickness of dermis [ Time Frame: 9 times in 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | October 2008 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: hydrocortisonacetat 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Other Name: Hydrogalen cream
Drug: betamethasonvalerat 0,1% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
Other Name: Betagalen cream
Drug: clobetasol-17-propionat 0,05% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
Other Name: Clobegalen cream
|
| Active Comparator: 2 |
Drug: pimecrolimus 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Other Name: Elidel 1% cream
Drug: betamethasonvalerat 0,1% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
Other Name: Betagalen cream
Drug: clobetasol-17-propionat 0,05% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
Other Name: Clobegalen cream
|
| Active Comparator: 3 |
Drug: pimecrolimus 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Other Name: Elidel 1% cream
Drug: hydrocortisonacetat 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Other Name: Hydrogalen cream
Drug: clobetasol-17-propionat 0,05% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
Other Name: Clobegalen cream
|
| Active Comparator: 4 |
Drug: pimecrolimus 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Other Name: Elidel 1% cream
Drug: hydrocortisonacetat 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Other Name: Hydrogalen cream
Drug: betamethasonvalerat 0,1% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
Other Name: Betagalen cream
|
| Placebo Comparator: 5 |
Drug: Placebo
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655512
Contacts
| Contact: Roland Aschoff, MD | 0049-351-458 ext 2007 | Roland.Aschoff@uniklinikum-dresden.de |
Locations
| Germany | |
| Department of Dermatology, Medical Faculty, TU Dresden | Recruiting |
| Dresden, Germany | |
| Contact: Roland Aschoff, MD 0049 351 458 ext 2007 Roland.Aschoff@uniklinikum-dresden.de | |
| Principal Investigator: Roland Aschoff, MD | |
| Sub-Investigator: Jochen Schmitt, MD | |
Sponsors and Collaborators
Dresden University of Technology
Investigators
| Principal Investigator: | Roland Aschoff, MD | Department of Dermatology, Medical Faculty, Technical University Dresden, Germany |
More Information
No publications provided
| Responsible Party: | Roland Aschoff, MD, Technical University Dresden |
| ClinicalTrials.gov Identifier: | NCT00655512 History of Changes |
| Other Study ID Numbers: | TUD-OCT011-023 |
| Study First Received: | April 4, 2008 |
| Last Updated: | October 29, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Dresden University of Technology:
|
pimecrolimus hydrocortison betamethasone |
clobetasol-17-Propionat Optical Coherence Tomography skin healthy probands |
Additional relevant MeSH terms:
|
Pimecrolimus Clobetasol Tacrolimus Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Antirheumatic Agents Dermatologic Agents Immunosuppressive Agents Immunologic Factors Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013