NCT00544687

Brief Summary

CRx-191 is a proprietary synergistic combination drug candidate being evaluated by CombinatoRx for topical psoriasis therapy. CRx-191 was identified via a proprietary screening assay for novel drug combinations demonstrating enhanced inhibition of tumor necrosis factor- alpha and interferon-gamma release, cytokines that are implicated in the pathogenesis of psoriasis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

November 15, 2007

Status Verified

November 1, 2007

First QC Date

October 15, 2007

Last Update Submit

November 14, 2007

Conditions

Healthy

Keywords

SkinAtrophyCRX-191mometasone furoatenortriptyline hydrochlorideSkin Thickness in Normal Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Full skin thinning produced by treatment of CRx-191 in comparison with its components at corresponding dose levels, and vehicle with a marketed corticosteriod. Assess tolerability and safety of CRx-191.

    28 Days

Study Arms (6)

1

EXPERIMENTAL

CRx-191 (0.1% mometasone furoate + 0.05% nortriptyline HCl)

Drug: CRx-191

2

EXPERIMENTAL

CRx-191 (0.1% mometasone furoate + 0.1% nortriptyline HCl)

Drug: CRx-191

3

ACTIVE COMPARATOR

0.1% mometasone furoate

Drug: mometasone furoate

4

ACTIVE COMPARATOR

0.1% nortriptyline HCl

Drug: nortriptyline HCl

5

ACTIVE COMPARATOR

Karison® Creme (clobetasol-17-propinate 0.05%)

Drug: Karison® Creme

6

PLACEBO COMPARATOR

Vehicle (placebo)

Drug: Vehicle

Interventions

CRx-191DRUG

topical (mometasone furoate + nortriptyline HCl)

12
mometasone furoateDRUG

topical mometasone furoate

3
nortriptyline HClDRUG

topical nortriptyline HCl

4
Karison® CremeDRUG

topical Karison® Creme (clobetasol-17-propinate 0.05%)

5
VehicleDRUG

topical (placebo)

6

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must voluntarily give written informed consent
  • Subject must be at least 18 years of age
  • Subject must have healthy skin on which reddening can be easily recognized in the area of the test fields
  • The physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study
  • Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen; systemic contraceptive (combined oral contraceptive, implant, injection), or safe intrauterine device (IUD)
  • Written informed consent obtained

You may not qualify if:

  • Acne, suntan, eczema, hyper- or hypopigmentation, or tattoos in 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 \< LLN, or receiving thyroid medication
  • Severe liver disease (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) laboratory values that exceed 1.5x ULN)
  • Inflammatory dermatoses (e.g. atopic dermatitis, psoriasis), bacterial, viral, or fungal skin infections; facial 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 preparations
  • Allergy to adhesives on the patches used for occlusion in this study
  • UV therapy in the four weeks before the study
  • History of malignancy (except for treated or excised basal cell carcinoma)
  • Surgery within the previous 3 months (except for minor cosmetic or dental procedures)
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

bioskin GmbH

Hamburg, Germany

Location

MeSH Terms

Conditions

Atrophy

Interventions

Mometasone FuroateNortriptyline

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Johannes Gassmueller, M.D.

    Bioskin GmbH

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 15, 2007

First Posted

October 16, 2007

Study Start

September 1, 2007

Study Completion

November 1, 2007

Last Updated

November 15, 2007

Record last verified: 2007-11

Locations

DE(1)