Cumulative Skin Irritation Potential of a New 25 mg Nicotine Patch
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|ClinicalTrials.gov Identifier: NCT00967174|
Recruitment Status : Completed
First Posted : August 27, 2009
Last Update Posted : July 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Drug: Nicotine Patch Drug: Placebo Patch Drug: SLS Comparator Patch||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Study on the Cumulative Skin Irritation Potential of a Newly Developed 25 mg Nicotine Transdermal Therapeutic System. A Double Blind, Randomized, Repeat Patch Test, Single Center Study in 42 Healthy Male and Female Subjects|
|Study Start Date :||May 2005|
|Primary Completion Date :||June 2005|
|Study Completion Date :||June 2005|
Experimental: Three Treatments Applied to Lower Back
Treatments were applied on the lower back, according to treatment sequence, daily for 21 days.
Drug: Nicotine Patch
25 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days.
Other Name: Experimental Nicotine PatchDrug: Placebo Patch
Placebo Patch applied on the lower back, according to treatment sequence, daily for 21 days.
Other Name: Placebo Paatch ComparatorDrug: SLS Comparator Patch
0.1% (w/v) SLS patch applied on the lower back, according to treatment sequence, daily for 21 days.
Other Name: SLS Comparator
- Cumulative Irritation Score (CIS10) [ Time Frame: @24 hours post- application for 21 days ]
- Cumulative Individual Irritation Score (CIIS) [ Time Frame: @24 hours post- application for 21 days ]
- Frequency Indices (FI) of irritation score [ Time Frame: @24 hours post- application for 21 days ]
- Time to irritation reaction [ Time Frame: @24 hours post- application for 21 days ]
- Patch adhesion score [ Time Frame: directly before patch removal ]
- Tolerability [ Time Frame: at each visit ]
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): NCT00967174
|Mannheim, Germany, 68167|
|Study Director:||Elisabeth Kruse, PhD||Mc Neil AB|