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Sponsored by: |
Dresden University of Technology |
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Information provided by: | Dresden University of Technology |
ClinicalTrials.gov Identifier: | NCT00655512 |
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 I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety Study |
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 |
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 |
---|---|
1: Active Comparator |
Drug: hydrocortisonacetat 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Drug: betamethasonvalerat 0,1% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
Drug: clobetasol-17-propionat 0,05% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
|
2: Active Comparator |
Drug: pimecrolimus 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Drug: betamethasonvalerat 0,1% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
Drug: clobetasol-17-propionat 0,05% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
|
3: Active Comparator |
Drug: pimecrolimus 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Drug: hydrocortisonacetat 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Drug: clobetasol-17-propionat 0,05% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
|
4: Active Comparator |
Drug: pimecrolimus 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Drug: hydrocortisonacetat 1% cream
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
Drug: betamethasonvalerat 0,1% cream
twice a day one fingertip at the testareas (forearm/back of the hand) for 4 weeks
|
5: Placebo Comparator |
Drug: Placebo
twice a day one fingertip at the testareas (forehead and forearm/back of the hand) for 4 weeks
|
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Roland Aschoff, MD | 0049-351-458 ext 2007 | Roland.Aschoff@uniklinikum-dresden.de |
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 |
Principal Investigator: | Roland Aschoff, MD | Department of Dermatology, Medical Faculty, Technical University Dresden, Germany |
Responsible Party: | Technical University Dresden ( Roland Aschoff, MD ) |
Study ID Numbers: | TUD-OCT011-023 |
Study First Received: | April 4, 2008 |
Last Updated: | April 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00655512 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
pimecrolimus hydrocortison betamethasone |
clobetasol-17-Propionat Optical Coherence Tomography skin healthy probands |
Betamethasone-17,21-dipropionate Anti-Inflammatory Agents Hydrocortisone Immunologic Factors Cortisol succinate Hormone Antagonists Betamethasone sodium phosphate Hormones, Hormone Substitutes, and Hormone Antagonists Pimecrolimus Healthy Tacrolimus |
Immunosuppressive Agents Glucocorticoids Hormones Clobetasol Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Hydrocortisone acetate Antirheumatic Agents Betamethasone |
Anti-Inflammatory Agents Immunologic Factors Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Pimecrolimus Tacrolimus Immunosuppressive Agents Glucocorticoids Hormones Pharmacologic Actions |
Clobetasol Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Dermatologic Agents |