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

NCT01301677 | Completed Phase 1

• 1 other identifier: XPM-033
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Erythema; Pain

Outcome Measures

Primary Outcomes (1)

• Degree of erythema

  at 6 h, 12 h, 24 h, 36 h, 48 h post UVR

Secondary Outcomes (1)

• Pain threshold (primary hyperalgesia to heat)

  Sum of assessments at 6 h, 12 h, 24 h, 36 h, 48 h post UVR

Study Arms (3)

Hydrocortisone

ACTIVE COMPARATOR

Drug: Hydrocortisone

2PX+

EXPERIMENTAL

strontium chloride hexahydrate in a penetration enhancing vehicle

Drug: 2PX+

2PX-

EXPERIMENTAL

strontium chloride hexahydrate without a penetration enhancing vehicle

Drug: 2PX-

Interventions

Hydrocortisone DRUG

Hydrocortisone liquid formulation

Hydrocortisone

2PX- DRUG

strontium chloride hexahydrate without a penetration enhancing vehicle

2PX-

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• X-pert Med GmbH: lead

Study Sites (2)

X-pert Med GmbH

Gräfelfing, Bavaria, 82166, Germany

Location

X-pert Med Gmbh

Jena, Thuringia, 07745, Germany

Location

MeSH Terms

Conditions

Erythema; Pain

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Ilka Rother, MD

  X-pert Med GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 23, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 29, 2011

Record last verified: 2011-06

Locations

DE (2)