A Phase I, Single-Center, Randomized, Vehicle-Controlled Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers

Zalicus1 site in 1 country20 target enrollmentJuly 2008

Interventionsnortriptyline HCl + loratadine nortriptyline HCl mometasone furoate Active ingredient free vehicle cream of CRx-197

Drugsnortriptyline HCl + loratadine nortriptyline HCl mometasone furoate Active ingredient free vehicle cream of CRx-197

Overview

Phase: Phase 1
Intervention: nortriptyline HCl + loratadine
Conditions: Atopic Dermatitis
Sponsor: Zalicus
Enrollment: 20
Locations: 1
Primary Endpoint: Safety and tolerability of CRx-197 as assessed by treatment emergent adverse events, physical exams, vital signs, concomitant medications/procedures and subject assessment of pruritus.
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This will be a phase I, single center, randomized, vehicle-controlled, blinded study comparing two dosage strengths of CRx-197 cream, nortriptyline, an active comparator (0.1% mometasone) and placebo (the active ingredient free vehicle cream of CRx-197)in healthy volunteers.

Registry

clinicaltrials.gov

Start Date

July 2008

End Date

September 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Investigators

Sponsor

Zalicus

Eligibility Criteria

Inclusion Criteria

•Subject must voluntarily sign and date the written Informed Consent prior to any study specific procedures
•Subject must be 18 to 60 years of age
•Subject must have healthy skin on which reddening can be easily recognized in the area where they will place the test fields
•Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
•Females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen. A highly effective method of birth control is defined as those which result in a lower failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner.

Exclusion Criteria

•Suntan, hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields
•Dark skinned persons whose skin color prevents ready assessment of skin reactions
•Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
•Narrow angle glaucoma
•Hyperthyroidism by medical history, TSH less than LLN, or subject receiving any thyroid medication
•Severe liver disease - ALT laboratory value that exceeds 1.5x ULN
•Inflammatory dermatoses (e.g., atopic dermatoses/eczema, psoriasis)
•Any skin condition involving the test fields including but not limited to bacterial, viral, or fungal skin infections, acne, rosacea
•Active varicella, tuberculosis, syphilis or post-vaccine reactions
•Autoimmune disease (e.g., lupus erythematosis)

Arms & Interventions

CRx-197 high dose (0.1% nortriptyline HCl + 0.3% loratadine)

Intervention: nortriptyline HCl + loratadine

CRx-197 low dose (0.1% nortriptyline HCl + 0.1% loratadine)

Intervention: nortriptyline HCl + loratadine

0.1% nortriptyline HCl

Intervention: nortriptyline HCl

0.1% mometasone furoate

Intervention: mometasone furoate

Active ingredient free vehicle cream of CRx-197

Intervention: Active ingredient free vehicle cream of CRx-197

Outcomes

Primary Outcomes

Safety and tolerability of CRx-197 as assessed by treatment emergent adverse events, physical exams, vital signs, concomitant medications/procedures and subject assessment of pruritus.

Time Frame: 2 months

Secondary Outcomes

Difference in change from baseline in psoriatic infiltrate measured by ultrasound between CRx-197, nortriptyline, active comparator as well as vehicle of CRx-197 and untreated test field(s)(Days 8, 15, 22, 29 and 43)
Difference in change from baseline in erythema measured by chronometry between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s) and normal skin(Days 8, 15, 22, 29 and 43)
Modified PASI between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s)(Baseline, and Days 8, 15, 22, 29 and 43)