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

This study has been completed.
Sponsor:
Information provided by:
X-pert Med GmbH
ClinicalTrials.gov Identifier:
NCT01301677
First received: February 17, 2011
Last updated: June 28, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Erythema
Pain
Drug: Hydrocortisone
Drug: 2PX+
Drug: 2PX-
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Degree of erythema [ Time Frame: at 6 h, 12 h, 24 h, 36 h, 48 h post UVR ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain threshold (primary hyperalgesia to heat) [ Time Frame: Sum of assessments at 6 h, 12 h, 24 h, 36 h, 48 h post UVR ] [ Designated as safety issue: No ]

Estimated Enrollment: 47
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hydrocortisone Drug: Hydrocortisone
Hydrocortisone liquid formulation
Experimental: 2PX+
strontium chloride hexahydrate in a penetration enhancing vehicle
Drug: 2PX+
strontium chloride hexahydrate in a penetration enhancing vehicle
Experimental: 2PX-
strontium chloride hexahydrate without a penetration enhancing vehicle
Drug: 2PX-
strontium chloride hexahydrate without a penetration enhancing vehicle

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed and dated informed consent prior to any study-mandated procedure
  • Subjects in good health as determined by the Investigator
  • Willing and able to comply with study requirements
  • Age ≥ 18
  • Fitzpatrick skin types I, II, or III
  • Willing to avoid sun exposure, tanning lamps and use of any topical products on the test areas during the study
  • Willing not to wash test areas during treatment period
  • Willing to abstain from sauna, exposure to extreme cold or major physical activities during the treatment period of the study
  • For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation

Exclusion Criteria:

General

  • Planned treatment or treatment with another investigational drug within 30 days prior to randomization.
  • Subjects who are inmates of psychiatric wards, prisons, or other state institutions
  • Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
  • Pregnancy or lactation
  • Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.

Medical History

  • Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma
  • Known hypersensitivity or allergy (including photoallergy) to hydrocortisone, strontium chloride hexahydrate, glycofurol, dimethylsulphoxide (DMSO), ethanol, propylene glycol, glycerol, hypomellose, sodium edentate, sodium hydroxide, citric acid monohydrate and metagin
  • History of photosensitivity disease
  • Sunburn, excessive tan, uneven skin tones or blemishes of the test areas
  • Pain conditions which might interfere with pain rating during the study, e.g. neuropathic pain
  • Open wounds, infection, inflammation or other dermal diseases of the intended application areas
  • ALT or AST ≥ 5 times the ULN
  • Glomerulary filtration rate < 30 ml/min

Medication History

  • Systemic or topical drugs that might affect responses to UVR or interfere with responses to IMP including corticosteroids, thiazides, tetracyclines and NSAIDs must be washed out with 5 times half-life time prior to randomization to treatment
  • Drugs with potential dermatologic adverse events defined by the respective summary of product characteristics (e.g. tetracyclines, gyrase inhibitors) must be washed out with 5 times half-life time prior to randomization to treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301677

Locations
Germany
X-pert Med GmbH
Graefelfing, Bavaria, Germany, 82166
X-pert Med Gmbh
Jena, Thuringia, Germany, 07745
Sponsors and Collaborators
X-pert Med GmbH
Investigators
Principal Investigator: Ilka Rother, MD X-pert Med GmbH
  More Information

No publications provided

Responsible Party: Ilka Rother, MD, X-pert Med GmbH
ClinicalTrials.gov Identifier: NCT01301677     History of Changes
Other Study ID Numbers: XPM-033
Study First Received: February 17, 2011
Last Updated: June 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Erythema
Skin Diseases
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on April 15, 2014