UVB Model Validation Study

Phase 1

Completed

• Conditions: Pain; Inflammation; Healthy Volunteers
• Interventions: Drug: Hydrocortisone; Drug: Ibuprofen, Hydrocortisone

• Registration Number: NCT01055249
• Lead Sponsor: X-pert Med GmbH

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:

1. IB 600 mg, applied orally b.i.d., or

2. OP, applied orally b.i.d.

Allocation of topical treatment to these areas will be randomly assigned to:

1. PG, 15 μl/cm2 applied topically b.i.d., or

2. 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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-25
• Primary Completion: 2010-06
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-12
• Last Update Posted: 2010-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• healthy volunteers

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	Hydrocortisone	Oral Placebo (placebo comparator), Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator)
Group A	Ibuprofen, Hydrocortisone	Ibuprofen 600 mg (active comparator); Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator)

Primary Outcome Measures

Name	Time	Method
Hyperalgesia to heat	72 h

Secondary Outcome Measures

Name	Time	Method
Erythema, Skin temperature	72 h

Trial Locations

Locations (1)

X-pert Med GmbH; 🇩🇪 Graefelfing, Bavaria, Germany

X-pert Med GmbH

🇩🇪Graefelfing, Bavaria, Germany