Cumulative Skin Irritation Potential of a New 15 mg Nicotine Patch

Study on the Cumulative Skin Irritation Potential of a Newly Developed 15 mg Nicotine Transdermal Therapeutic System. A Double Blind, Randomized, Repeat Patch Test, Single Center Study in 42 Healthy Male and Female Subjects

An investigation on the cumulative skin irritation potential of a newly developed 15 mg nicotine patch. Evaluation of skin irritation of a newly developed 15 mg nicotine transdermal patch.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Nicotine Patch; Drug: Nicotine Patch Comparator; Drug: Placebo Patch

Detailed Description

Study on the cumulative skin irritation potential of a newly developed 15 mg nicotine transdermal therapeutic system. A double blind, randomized, repeat patch test, single center study in 42 healthy male and female subjects.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Mannheim, Germany, 68167
    • IKP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and female subjects between 18 and 65 years
• Heavy smokers (more than 10 cigarettes per day)
• Having had no febrile or infectious illness for at least seven days prior to the first administration of the investigational product.
• Women practicing one or a combination of the following methods of birth control: hormonal contraceptives, condoms, sponge, foams, jelly, diaphragm, or intrauterine device or women who are surgically sterilized.
• Subjects having normal skin without excessive hair growth on tested areas.
• Evidence of a personally signed and dated informed consent document indicating that the subjects has been informed of all pertinent aspects of the trial.
• Subjects who are willing to comply with scheduled visits, treatment plan and other trial procedures.

Exclusion Criteria:

• Any visible skin disorder or abnormal skin pigmentation which, in the opinion of the investigator, would interfere with the outcome of the trial
• Dermatologic disease that might interfere with the evaluation of the test site reaction
• History of chronic, dermatological, medical, or physical conditions which would, in the opinion of the investigator, preclude topical application of the test products and/or influence the outcome of the test (in particular, any immunosuppressive condition)
• Clinically relevant abnormal findings on the physical examination
• A baseline score in skin reaction assessments other than "0" on the areas to be patched
• Pregnant (verified by beta-hCG-test in urine) and/or nursing women
• Demonstrating any active physical disease, acute or chronic
• Any suspicion, history or evidence of alcohol or drug abuse
• Any history of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis as well as current hay fever
• Any current or past history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, psychiatric or cardiovascular disease, myopathies, epileptic seizures and bleeding tendency
• Recent myocardial infarct (within the last 3 months), unstable or deteriorating angina pectoris, coronary artery vasospasm (Prinzmetal's angina), serious cardiac arrythmias and acute stroke
• Use of any medication within 4 weeks prior to the first treatment or during the trial, which in the opinion of the investigator may influence the trial results or the safety of the subjects
• Subjects having used nicotine products other than cigarettes within the 3 months preceding the trial or within 10 times the respective elimination half-life, whichever is longer
• Subjects who cannot avoid, throughout the duration of the trial, any swimming, any washing of the back and sauna or any intense physical activity that might result in excessive sweating
• Known sensitivity to adhesive tape
• Known sensitivity to any component of the test products
• History of irritation to topically applied products
• Fissure or injury of the skin at the test area
• Participation in the treatment phase of a clinical trial within 30 days prior to the treatment phase of this trial or within 10 times the respective elimination half-life of the investigational drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Three Interventions on Lower Back; Three treatments were applied on the lower back, according to treatment sequence, daily for 21 days

Drug: Nicotine Patch; 15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days; Other Names: Experimental Nicotine Patch; Drug: Nicotine Patch Comparator; 15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days; Other Names: Active Comparator Nicotine Patch; Drug: Placebo Patch; Placebo patch applied on the lower back, according to treatment sequence, daily for 21 days; Other Names: Placebo Patch Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative Irritation Score (CIS10)	@24 hours post- application for 21 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Patch adhesion score	directly before patch removal
Tolerability	at each visit
Cumulative Individual Irritation Score (CIIS)	@24 hours post- application for 21 days
Frequency Indices (FI) of irritation score	@24 hours post- application for 21 days
Time to irritation reaction	@24 hours post- application for 21 days

Collaborators and Investigators

• Sponsor: McNeil AB
• Investigators: Study Director: Elisabeth Kruse, PhD, Mc Neil AB

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): May 1, 2005
• Study Completion (Actual): June 1, 2005

Study Registration Dates

• First Submitted: August 25, 2009
• First Submitted That Met QC Criteria: August 25, 2009
• First Posted (Estimate): August 26, 2009

Study Record Updates

• Last Update Posted (Estimate): June 29, 2012
• Last Update Submitted That Met QC Criteria: June 27, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: A6431082; 2005-001044-23 (EudraCT Number); 012/05-03.NSI (Other Identifier: CRO)