A Phase I Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721331
• Other study ID #: CRx-197-001
• Secondary ID: EudraCT # 2008-0
• Status: Completed
• Phase: Phase 1
• First received: July 21, 2008
• Last updated: September 24, 2008
• Start date: July 2008
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: Zalicus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

• Mania

• 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)

• Known allergic reactions or hypersensitivity to any of the components of the study treatments

• Allergy to adhesives on the patches used for occlusion in the study

• UV therapy or significant UV exposure in the four weeks before treatment application

• History of malignancy (except for treated or excised basal cell carcinoma)

• Surgery within the previous 3 months (except for minor cosmetic or dental procedures)

• History of drug or alcohol abuse (as defined by the Investigator)

• Symptoms of a clinically significant illness in the four weeks before treatment application that may influence the outcome of the study

• Positive for HIV antibody

• Systemic treatments in the four weeks prior to treatment application that may interact with any of the study drugs, such as: Glucocorticoids, MAO inhibitors, anti-depressants, anti-seizure medications, anti-psychotics and anti-histamines

• Subjects who require medications that inhibit the CYP450 2D6 pathway such as:Quinidine, Cimetidine, Type 1 anti-arrhythmic, Phenothiazines, Selective serotonin reuptake inhibitors, Reserpine, other anticholinergic drugs, and sympathomimetic drugs

• Treatment with any investigational agent within one month before treatment application for this trial

• Female subject who is pregnant , lactating, or with a positive pregnancy test

• Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule

• Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment

• Subject is institutionalized because of legal or regulatory order

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• nortriptyline HCl + loratadine
Topical
• nortriptyline HCl + loratadine
Topical
• nortriptyline HCl
Topical
• mometasone furoate
Topical
• Active ingredient free vehicle cream of CRx-197
Topical

Locations

Country	Name	City	State
Germany	PROINNOVERA GmbH	Muenster

Sponsors (1)

Lead Sponsor	Collaborator
Zalicus

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 months	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No