UVB Model Validation Study

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055249
• Other study ID #: XPM-024
• Status: Completed
• Phase: Phase 1
• First received: January 22, 2010
• Last updated: July 12, 2010
• Start date: January 2010

Study information

• Verified date: July 2010
• Source: X-pert Med GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

Related Conditions & MeSH terms

• Healthy Volunteers
• Inflammation
• Pain

Intervention

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

Locations

Country	Name	City	State
Germany	X-pert Med GmbH	Graefelfing	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
X-pert Med GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyperalgesia to heat		72 h
Secondary	Erythema, Skin temperature		72 h

External Links

•   link to Sponsor and investigational site