- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01055249
UVB Model Validation Study
Single Centre, Subject and Observer Blinded, Placebo Controlled, Cross-over Study of the Effect of Oral Ibuprofen and Topical Hydrocortisone-21-acetate on Ultraviolet Radiation (UVR) Induced Pain and Inflammation in Healthy Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers conducted in two segments and using an intra-individual comparison of application areas.
Subjects that signed the informed consent and are eligible to the study will be irradiated on the back to evaluate their individual minimal erythema doses (MEDs). Read out to determine MED will be done within 24 h after UVR.
A training session (without study medication) using the MED definition areas will be performed in order to introduce subjects to the testing and rating procedures.
Subjects will come in within 14 days of screening to start the first Segment of the study. Eligible subjects will be randomised to receive either:
- IB 600 mg, applied orally b.i.d., or
- OP, applied orally b.i.d.
Allocation of topical treatment to these areas will be randomly assigned to:
- PG, 15 μl/cm2 applied topically b.i.d., or
- HC, 15 μl/cm2 applied topically b.i.d.
Defined areas will be irradiated with defined dosages of UVR. Assessment of hyperalgesia to heat and signs of inflammation (erythema, skin temperature) for all areas will be performed.
Subjects return within 4 to 11 days to the study site for the second segment of the study. Treatment allocation will be crossed-over and new treatment areas will be selected on the back.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Bavaria
-
Graefelfing, Bavaria, Germany, 82166
- X-pert Med GmbH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy volunteers
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Group A
Ibuprofen 600 mg (active comparator); Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator)
|
Ibuprofen 600 mg film coated tablets, b.i.d., Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.
|
Other: Group B
Oral Placebo (placebo comparator), Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator)
|
Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hyperalgesia to heat
Time Frame: 72 h
|
72 h
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Erythema, Skin temperature
Time Frame: 72 h
|
72 h
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Inflammation
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ibuprofen
- Hydrocortisone
- Hydrocortisone 17-butyrate 21-propionate
- Hydrocortisone acetate
- Hydrocortisone hemisuccinate
Other Study ID Numbers
- XPM-024
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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