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

NCT00721331 | Completed Phase 1

• 2 other identifiers: CRx-197-001EudraCT # 2008-000611-15
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

CombinatoRx; Atopic; Dermatitis; Topical; CRx-197; Normal Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (5)

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

EXPERIMENTAL

Drug: nortriptyline HCl + loratadine

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

EXPERIMENTAL

Drug: nortriptyline HCl + loratadine

0.1% nortriptyline HCl

EXPERIMENTAL

Drug: nortriptyline HCl

0.1% mometasone furoate

ACTIVE COMPARATOR

Drug: mometasone furoate

Active ingredient free vehicle cream of CRx-197

PLACEBO COMPARATOR

Drug: Active ingredient free vehicle cream of CRx-197

Interventions

nortriptyline HCl + loratadine DRUG

Topical

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

nortriptyline HCl DRUG

Topical

0.1% nortriptyline HCl

mometasone furoate DRUG

Topical

0.1% mometasone furoate

Active ingredient free vehicle cream of CRx-197 DRUG

Topical

Active ingredient free vehicle cream of CRx-197

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zalicus: lead

Study Sites (1)

PROINNOVERA GmbH

Münster, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis

Interventions

Nortriptyline; Loratadine; Mometasone Furoate

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Cyproheptadine; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Jutta Harten, MD

  Proinnovera GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 24, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 26, 2008

Record last verified: 2008-09

Locations

DE (1)