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| ID | Type | Description | Link |
|---|---|---|---|
| CCSTOH003710 | Other Identifier | Johnson & Johnson Consumer Inc. (J&JCI) |
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The purpose of this study is to evaluate the effectiveness and tolerability of a hydrocolloid bandage on pimples when used overnight for one week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group: Prototype Ultrathin Hydrocolloid Bandage and Study Cleanser | Experimental | Participants will wash their faces with the study cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5) in the evening prior to bandage application and in the morning after removing the bandage(s) on Days 0 through 7. On Days 7 through 14, no bandages will be worn and participants will wash their faces with the study cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5) in the morning and evening. Participants will cover their closed and popped pimples in the evening with 1 or 2 bandages on Days 0 through 6. |
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| Control Group: Study Cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5) | Active Comparator | Participants will wash their face twice daily using the study cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5) for up to 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5) | Drug | Participants will wash their face with the study cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5) for up to 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in General Wound Appearance Score of the Popped Pimple | Change from baseline in general wound appearance of the popped pimple will be assessed. It is evaluated on a scale from 0 to 4 with 0=poor (new or fresh wound with the epithelium layer missing, wound bed appears raw and possibly oozing); 1=fair (epithelial growth is starting to occur, wound bed is dry); 2=good (epithelial growth is clearly evident, wound bed color is no more than moderate erythema, scabbing may be present); 3=very good (wound bed indentation is slightly visible, wound area is mostly covered with epithelial regrowth, slight scabbing may be present); 4=excellent (fully healed, skin flush against surrounding skin, slight color mismatch may be present), with higher scores indicating a better outcome. | Baseline (Day 0) up to Day 14 |
| Percentage of Healed Popped Pimples | Percentage of healed popped pimples is defined as general wound appearance score greater than or equal to (>=) 3.5. General wound appearance is evaluated on a scale from 0 to 4 with 0=poor (new or fresh wound with the epithelium layer missing, wound bed appears raw and possibly oozing); 1=fair (epithelial growth is starting to occur, wound bed is dry); 2=good (epithelial growth is clearly evident, wound bed color is no more than moderate erythema, scabbing may be present); 3=very good (wound bed indentation is slightly visible, wound area is mostly covered with epithelial regrowth, slight scabbing may be present); 4=excellent (fully healed, skin flush against surrounding skin, slight color mismatch may be present), with higher scores indicating a better outcome. | Baseline (Day 0) up to Day 14 |
| Change from Baseline in Full Face Cutaneous Tolerance as Assessed by Trained Graders | Change from baseline in full face cutaneous tolerance as assessed by trained graders will be reported. It is evaluated on 3 criteria's: erythema, edema and dryness/scaling, all with a range of 0=none/absent, 1=mild, 2=moderate, and 3=severe, with higher scores indicating a worse outcome. | Baseline (Day 0) up to Day 14 |
| Change from Baseline in Full Face Cutaneous Tolerance as Assessed by Participants |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Clinical Grading of Wound Healing of Edema of a Popped Pimple | Change from baseline in clinical grading of wound healing of a popped pimple will be reported. Grading of edema will be evaluated on a scale of 0 to 4 with 0=none/absent, 1=mild, 2=moderate, 3=marked; and 4=severe, with higher scores indicating a worse outcome. | Baseline (Day 0) up to Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Summer Acevedo, PhD | Stephens SGS, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Stephens Inc. | Richardson | Texas | 75081 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32238884 | Background | Heng AHS, Chew FT. Systematic review of the epidemiology of acne vulgaris. Sci Rep. 2020 Apr 1;10(1):5754. doi: 10.1038/s41598-020-62715-3. | |
| 23163336 | Background | Tripathi SV, Gustafson CJ, Huang KE, Feldman SR. Side effects of common acne treatments. Expert Opin Drug Saf. 2013 Jan;12(1):39-51. doi: 10.1517/14740338.2013.740456. Epub 2012 Nov 20. |
| Label | URL |
|---|---|
| Related Info | View source |
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Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Prototype Ultrathin Hydrocolloid Bandage | Device | Participants will cover their closed and popped pimples in the evening with one or two bandages from Days 0 through 6. |
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Change from baseline in full face cutaneous tolerance as assessed by participants will be reported. It is evaluated on 3 criteria's: burning/stinging, itching and tight/dry feeling, all with a range of 0=none (no burning/stinging or itching or no skin tightness/dry feeling of the treatment area); 1= mild (slight burning/stinging sensation or itching or definite tightness or dry feeling of the treatment area; not really bothersome); 2=moderate (definite warm burning/stinging or itching or tightness or dry feeling of the treatment area that is somewhat bothersome) 3=severe (marked burning/stinging sensation or itching sensation or tightness/dry feeling of the treatment area that causes definite discomfort and may interrupt daily activities and/or sleep), with higher scores indicating a worse outcome. |
| Baseline (Day 0) up to Day 14 |
| Change from Baseline in Clinical Grading of Wound Healing of Crusting/Scabbing of a Popped Pimple | Change from baseline in clinical grading of wound healing of crusting/scabbing of a popped pimple will be reported. Grading of crusting/scabbing will be evaluated on a scale of 0 to 4 with 0=none; 1=slight (up to 30 percent [%]); 2=moderate (31% to 60%); 3=extensive (61% to 90%); and 4=almost complete or complete (91% to 100%), with higher scores indicating a worse outcome. | Baseline (Day 0) up to Day 14 |
| Change from Baseline in Clinical Grading of Wound Healing of Smoothness of a Popped Pimple | Change from baseline in clinical grading of wound healing of smoothness of popped pimple as assessed by trained grader will be reported. Grading of smoothness will be evaluated on a scale of 0 to 4 with 0=rough, uneven wound, 1=mild smoothness, 2=moderate smoothness, 3=extensive smoothness, and 4=complete smooth, even wound, with higher scores indicating a better outcome. | Baseline (Day 0) up to Day 14 |
| Change from Baseline in Clinical Acne Grading of Erythema of a Closed and Popped Pimples | Change from baseline in clinical acne grading of erythema of a closed and popped pimple will be reported. Grading of erythema will be evaluated on a scale of 0 to 4 with 0=none, 1=slight, 2=mild, 3=moderate, and 4=severe, with higher scores indicating a worse outcome. | Baseline (Day 0) up to Day 14 |
| Change from Baseline in Clinical Acne Grading of Size (Diameter) of a Closed and Popped Pimples | Change from baseline in clinical acne grading of size (diameter) of a closed and popped pimple will be reported. Grading of size will be evaluated on a scale of 0 to 4 with 0=no visible lesion, 1=slightly visible lesion; less than (<) 2 millimeters (mm), 2=small lesion; 2.0 mm to 3.0 mm, 3=medium lesion; 3.1 mm to < 5.0 mm, and 4=large lesion; greater than or equal to (>=) 5.0 mm, with higher scores indicating a worse outcome. | Baseline (Day 0) up to Day 14 |
| Change from Baseline in Clinical Acne Grading of Elevation of a Closed and Popped Pimples | Change from baseline in clinical acne grading of elevation of a closed and popped pimple will be reported. Grading of elevation will be evaluated on a scale of 0 to 4 with 0=completely flat, 1=slightly raised, 2=mildly raised, 3=moderately raised, and 4=severely raised, with higher scores indicating a worse outcome. | Baseline (Day 0) up to Day 14 |
| Change from Baseline in Clinical Acne Grading of Dryness/Scaling of a Closed and Popped Pimples | Change from baseline in clinical acne grading of dryness/scaling of a closed and popped pimple will be reported. Grading of dryness/scaling will be evaluated on a scale of 0 to 4 with 0=none, 1=mild, 2=moderate, and 3=severe, with higher scores indicating a worse outcome. | Baseline (Day 0) up to Day 14 |
| Change from Baseline in Investigator's Global Assessment (IGA) of Acne Severity | Change from baseline in IGA of acne severity will be reported. The IGA scale for acne reflects the Investigator's assessment of the severity of a participant's acne on a scale from 0 to 5 with 0 (clear skin), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe), 5 (very severe). Each of these gradations is based upon a lesion count by the Investigator. | Baseline (Day 0) up to Day 14 |
| Microbiome Analysis of Closed and Popped Pimple | Microbiome analysis of closed and popped pimple for Days 0 and 7 will be reported. Microbiome sample swabs will be used to collect bacteria from the skin surface and will be processed by CosmosID Inc using spike-in quantification controls and shallow shotgun metagenome sequencing at 3-4 millions (M) reads per sample. | Baseline (Day 0) and Day 7 |
| Consumer Perception Questionnaire | Consumer perception will be assessed quantitatively by consumer perception questionnaire which consists of some questions regarding how participants feel about using the bandages. In order to capture this information, a smartphone app called dscout will be used that will allow the participants to easily provide the information with a glimpse of the experience. In each research activity, participants will be asked to answer a set of questions and submit a photo and/or video of him/her. | Up to Day 13 |
| Standardized Digital Photographs of Full Face | Standardized digital photographs of full face (right, center, left) will be captured using the Johnson & Johnson (J&J) Lab Imaging System for qualitative image analysis. It will assess visual improvements in closed and popped pimples. | Baseline (Day 0) up to Day 14 |
| Background | Mayo Foundation for Medical Education and Research. Acne Treatment. Retrieved from https://www.mayoclinic.org/diseases-conditions/acne/diagnosis-treatment/drc-20368048 |
| 16688374 | Background | Chao CM, Lai WY, Wu BY, Chang HC, Huang WS, Chen YF. A pilot study on efficacy treatment of acne vulgaris using a new method: results of a randomized double-blind trial with Acne Dressing. J Cosmet Sci. 2006 Mar-Apr;57(2):95-105. |