UVB Model Validation Study
|Pain Inflammation Healthy Volunteers||Drug: Ibuprofen, Hydrocortisone Drug: Hydrocortisone||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||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|
- Hyperalgesia to heat [ Time Frame: 72 h ]
- Erythema, Skin temperature [ Time Frame: 72 h ]
|Study Start Date:||January 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Ibuprofen 600 mg (active comparator); Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator)
Drug: Ibuprofen, Hydrocortisone
Ibuprofen 600 mg film coated tablets, b.i.d., Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055249
|X-pert Med GmbH|
|Graefelfing, Bavaria, Germany, 82166|