A Phase 1 interventional study of Ibuprofen, Hydrocortisone and Hydrocortisone in Pain, Inflammation and Healthy Volunteers, sponsored by X-pert Med GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-07-13.
Sponsored by X-pert Med GmbH · Phase 1, Interventional, and Basic science
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.
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:
Allocation of topical treatment to these areas will be randomly assigned to:
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's planned enrollment of 24 is below the median of 50 across 2,437 interventional studies indexed under Inflammation.
Browse Inflammation studies →X-pert Med GmbH is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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Ibuprofen 600 mg (active comparator); Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator)
Drug: Ibuprofen, Hydrocortisone
Oral Placebo (placebo comparator), Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator)
Drug: Hydrocortisone
Ibuprofen 600 mg film coated tablets, b.i.d., Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.
Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.
Hyperalgesia to heat
Time frame: 72 h
Erythema, Skin temperature
Time frame: 72 h
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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X-pert Med GmbH