A Phase I Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT00721331 |
Recruitment Status :
Completed
First Posted : July 24, 2008
Last Update Posted : September 26, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atopic Dermatitis | Drug: nortriptyline HCl + loratadine Drug: nortriptyline HCl Drug: mometasone furoate Drug: Active ingredient free vehicle cream of CRx-197 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | September 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: CRx-197 high dose (0.1% nortriptyline HCl + 0.3% loratadine) |
Drug: nortriptyline HCl + loratadine
Topical |
Experimental: CRx-197 low dose (0.1% nortriptyline HCl + 0.1% loratadine) |
Drug: nortriptyline HCl + loratadine
Topical |
Experimental: 0.1% nortriptyline HCl |
Drug: nortriptyline HCl
Topical |
Active Comparator: 0.1% mometasone furoate |
Drug: mometasone furoate
Topical |
Placebo Comparator: Active ingredient free vehicle cream of CRx-197 |
Drug: Active ingredient free vehicle cream of CRx-197
Topical |
- 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 ]
- 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) [ Time Frame: 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 [ Time Frame: Days 8, 15, 22, 29 and 43 ]
- Modified PASI between CRx-197, nortriptyline, active comparator, vehicle of CRx-197, untreated test field(s) [ Time Frame: Baseline, and Days 8, 15, 22, 29 and 43 ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721331
Germany | |
PROINNOVERA GmbH | |
Muenster, Germany |
Principal Investigator: | Jutta Harten, MD | Proinnovera GmbH |
Responsible Party: | James Keane, Sr. Clinical Project Manager, CombinatoRx, Inc. |
ClinicalTrials.gov Identifier: | NCT00721331 |
Other Study ID Numbers: |
CRx-197-001 EudraCT # 2008-000611-15 |
First Posted: | July 24, 2008 Key Record Dates |
Last Update Posted: | September 26, 2008 |
Last Verified: | September 2008 |
CombinatoRx Atopic Dermatitis |
Topical CRx-197 Normal Healthy Volunteers |
Dermatitis, Atopic Dermatitis Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Mometasone Furoate Loratadine Nortriptyline Anti-Inflammatory Agents Dermatologic Agents Anti-Allergic Agents |
Antipruritics Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Adrenergic Agents |