UVB Model Validation Study

NCT ID: NCT01055249

Last Updated: 2010-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31

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.

Conditions

Pain; Inflammation; Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Group A

Ibuprofen 600 mg (active comparator); Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator)

Group Type: OTHER

Ibuprofen, Hydrocortisone

Intervention Type: DRUG

Ibuprofen 600 mg film coated tablets, b.i.d., Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.

Group B

Oral Placebo (placebo comparator), Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator)

Group Type: OTHER

Hydrocortisone

Intervention Type: DRUG

Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.

Interventions

Ibuprofen, Hydrocortisone

Ibuprofen 600 mg film coated tablets, b.i.d., Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.

Intervention Type: DRUG

Hydrocortisone

Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• healthy volunteers

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

X-pert Med GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

X-pert Med GmbH

Locations

X-pert Med GmbH

Gräfelfing, Bavaria, Germany

Countries

Germany

Other Identifiers

XPM-024

Identifier Type: -

Identifier Source: org_study_id