UVB Model Validation Study

This study has been completed.
Sponsor:
Information provided by:
X-pert Med GmbH
ClinicalTrials.gov Identifier:
NCT01055249
First received: January 22, 2010
Last updated: July 12, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Pain
Inflammation
Healthy Volunteers
Drug: Ibuprofen, Hydrocortisone
Drug: Hydrocortisone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by X-pert Med GmbH:

Primary Outcome Measures:
  • Hyperalgesia to heat [ Time Frame: 72 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Erythema, Skin temperature [ Time Frame: 72 h ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
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.
Group B
Oral Placebo (placebo comparator), Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator)
Drug: Hydrocortisone
Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055249

Locations
Germany
X-pert Med GmbH
Graefelfing, Bavaria, Germany, 82166
Sponsors and Collaborators
X-pert Med GmbH
  More Information

Additional Information:
No publications provided

Responsible Party: Ilka Rother, MD, X-pert Med GmbH
ClinicalTrials.gov Identifier: NCT01055249     History of Changes
Other Study ID Numbers: XPM-024
Study First Received: January 22, 2010
Last Updated: July 12, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by X-pert Med GmbH:
UVB
pain
inflammation
model
healthy volunteers
Ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Ibuprofen
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 14, 2014