UVB Model Validation Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pain, Inflammation, Healthy Volunteers

Intervention / Treatment
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* Drug: Ibuprofen, Hydrocortisone
* Drug: Hydrocortisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy volunteers Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Ibuprofen 600 mg (active comparator); Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator) | Drug: Ibuprofen, Hydrocortisone<br>* Ibuprofen 600 mg film coated tablets, b.i.d., Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.<br>|
| Other: Group B<br>Oral Placebo (placebo comparator), Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator) | Drug: Hydrocortisone<br>* Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperalgesia to heat |  | 72 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema, Skin temperature |  | 72 h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UVB, pain, inflammation, model, healthy volunteers, Ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers