Adhesive Tape Trauma Clinical Trial
Official title:
Adhesive Tape Trauma Evaluation of Two Gentle Tapes in Healthy Human Infant Subjects
| Verified date | October 2012 |
| Source | 3M |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | June 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 6 Months to 4 Years |
| Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United States | cyberDERM | Broomall | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| 3M |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Skin Trauma | Expert grader using Erythema/Edema Scale 0=No visible response mild response moderate response severe response extreme response |
24 hours | No |