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

January 22, 2010
July 12, 2010
January 2010
June 2010   (final data collection date for primary outcome measure)
Hyperalgesia to heat [ Time Frame: 72 h ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01055249 on ClinicalTrials.gov Archive Site
Erythema, Skin temperature [ Time Frame: 72 h ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
UVB Model Validation Study
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
  • Pain
  • Inflammation
  • Healthy Volunteers
  • Drug: Ibuprofen, Hydrocortisone
    Ibuprofen 600 mg film coated tablets, b.i.d., Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.
  • Drug: Hydrocortisone
    Hydrocortisone-21-acetate creme (25%) 15 microl/cm2 b.i.d.
  • Group A
    Ibuprofen 600 mg (active comparator); Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator)
    Intervention: Drug: Ibuprofen, Hydrocortisone
  • Group B
    Oral Placebo (placebo comparator), Hydrocortisone 15 microl/cm2 (active comparator); Placebo Gel (placebo comparator)
    Intervention: Drug: Hydrocortisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Not Provided
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

-

Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01055249
XPM-024
No
Ilka Rother, MD, X-pert Med GmbH
X-pert Med GmbH
Not Provided
Not Provided
X-pert Med GmbH
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP