NCT01301677

Ultra Violet B Radiation (UVR) Study of Strontium Chloride Hexahydrate Hydrocortisone

Double-blind, Randomised, Active (Hydrocortisone) Controlled Study of the Effect of 10% w/v Strontium Chloride Hexahydrate on Ultraviolet B Radiation (UVR) Induced Signs of Inflammation (Erythema and Pain) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: X-pert Med GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Double blinded (subject and observer), randomised, active (hydrocortisone (HC)) controlled study of the effect of strontium chloride hexahydrate on ultraviolet B radiation (UVR) induced signs of inflammation (erythema and pain) in healthy volunteers.

Detailed description

Subjects that signed the informed consent and are eligible to the study will be irradiated on the back to evaluate their individual minimal erythema dose (MED). A training session (without study medication) will be performed in order to introduce subjects to the testing and rating procedures. Subjects will come in within 28 days of screening to start the treatment period of the study. For eligible subjects, three test areas oriented along the long axis of the back and different from the areas of MED determination will be defined for the evaluation of effects on pain and inflammation induced by UVR. The three areas will be irradiated with 2 MED. In addition, non-irradiated, not treated areas will serve as reference and training areas for the individual visits. Topical treatments will be randomly assigned to the three test areas.

Conditions

• Erythema
• Pain

Interventions

Type	Name	Description
DRUG	Hydrocortisone	Hydrocortisone liquid formulation
DRUG	2PX+	strontium chloride hexahydrate in a penetration enhancing vehicle
DRUG	2PX-	strontium chloride hexahydrate without a penetration enhancing vehicle

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-02-23
• Last updated: 2011-06-29

Locations

2 sites across 1 country: Germany