Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Broomall, Pennsylvania 19008


Purpose:

The objective of this study is to determine the relative gentleness of two tapes recognized for gentleness. A three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used.


Study summary:

The objective of this study is to determine the relative gentleness of a new investigational tape compared to 3M Micropore tape, a gold standard tape recognized for its gentleness and used as a mainstay in cosmetic surgery and neonatal care. A three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used.


Criteria:

Inclusion Criteria: 1. Who are healthy and who have intact skin at the test site with a baseline score of 0 for erythema 2. Who are between the ages of 6 months - 4 years of age 3. Who has a Fitzpatrick Skin Type of I, II or III 4. Subject who's parent agrees to not use any products (i.e. topical medications, creams, powders or ointments) on the test sites for 24 hours prior to the study start date 5. Whose parent is willing to sign the Informed Consent Form. Exclusion Criteria: 1. Who are known to be developmentally delayed 2. Who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test sites 3. Who have had any exposure to other topical medications, creams, powders, or ointments on the test sites 24 hours prior to the start of the study. 4. Who have had a strep infection within the past 2 weeks 5. Who have a history of diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions 6. Who have allergies to isocyanates, or acrylate adhesive products 7. Who currently take any antihistamines or anti-inflammatory medication or who have taken any of these medications within 48 hours prior to the start of the study or does not agree to refrain from taking these medications for the 48 hours prior to the start of the study and for the duration of the study (Tylenol is an acceptable pain reliever).


Study is Available At:


Original ID:

EM-05-012247


NCT ID:

NCT01354106


Secondary ID:


Study Acronym:


Brief Title:

Adhesive Tape Trauma Evaluation of Two Gentle Tapes


Official Title:

Adhesive Tape Trauma Evaluation of Two Genlte Tapes in Healthy Human Infant Subjects


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

6 Months


Maximum Age:

4 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

3M


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

24


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gary L Grove, PhD
Principal Investigator
cyberDERM

Study Dates

Start Date:May 2011
Completion Date:June 2011
Completion Type:Actual
Primary Completion Date:June 2011
Primary Completion Type:Actual
Verification Date:August 2011
Last Changed Date:August 31, 2011
First Received Date:May 13, 2011

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Device
Name:Medical Tape (3M Micropore , Investigational tape
Description:24 wear with two gentle tapes
Arm Name:Infant
Other Name:3M Micropore

Study Arms

Study Arm Type:Other
Arm Name:Infant

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:3M

Samples and Retentions

Study Population: Infant
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.