UVB Model Validation Study

This study has been completed.

Sponsor:

Information provided by:

X-pert Med GmbH

ClinicalTrials.gov Identifier:

NCT01055249

First received: January 22, 2010

Last updated: July 12, 2010

Last verified: July 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	January 22, 2010
Last Updated Date	July 12, 2010
Start Date ^ICMJE	January 2010
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 22, 2010)	Hyperalgesia to heat [ Time Frame: 72 h ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01055249 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 22, 2010)	Erythema, Skin temperature [ Time Frame: 72 h ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	UVB Model Validation Study
Official Title ^ICMJE	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
Brief Summary	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.
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 ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Basic Science
Condition ^ICMJE	Pain Inflammation Healthy Volunteers
Intervention ^ICMJE	Drug: Ibuprofen, Hydrocortisone Ibuprofen 600 mg film coated tablets, b.i.d., Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d. Drug: Hydrocortisone Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.
Study Arm (s)	Group A Ibuprofen 600 mg (active comparator); Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator) Intervention: Drug: Ibuprofen, Hydrocortisone Group B Oral Placebo (placebo comparator), Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator) Intervention: Drug: Hydrocortisone
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	24
Completion Date	Not Provided
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: healthy volunteers Exclusion Criteria: -
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01055249
Other Study ID Numbers ^ICMJE	XPM-024
Has Data Monitoring Committee	No
Responsible Party	Ilka Rother, MD, X-pert Med GmbH
Study Sponsor ^ICMJE	X-pert Med GmbH
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	X-pert Med GmbH
Verification Date	July 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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