A Study of a Hydrocolloid Bandage on Pimples

• ClinicalTrials.gov Identifier: NCT05012735
• Recruitment Status: Completed
• First Posted: August 19, 2021
• Last Update Posted: September 16, 2022
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Information provided by (Responsible Party): Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

Study Description

Brief Summary:

The purpose of this study is to evaluate the effectiveness and tolerability of a hydrocolloid bandage on pimples when used overnight for one week.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: Study Cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5); Device: Prototype Ultrathin Hydrocolloid Bandage	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: An Evaluation of the Safety and Efficacy of a Hydrocolloid Bandage on Pimples
• Actual Study Start Date: July 19, 2021
• Actual Primary Completion Date: September 13, 2021
• Actual Study Completion Date: September 13, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment Group: Prototype Ultrathin Hydrocolloid Bandage and Study Cleanser; 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.	Drug: Study Cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5); Participants will wash their face with the study cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5) for up to 14 days.; Device: Prototype Ultrathin Hydrocolloid Bandage; Participants will cover their closed and popped pimples in the evening with one or two bandages from Days 0 through 6.
Active Comparator: Control Group: Study Cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5); 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.	Drug: Study Cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5); Participants will wash their face with the study cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5) for up to 14 days.

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline in General Wound Appearance Score of the Popped Pimple [ Time Frame: Baseline (Day 0) up to Day 14 ]
   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.
2. Percentage of Healed Popped Pimples [ Time Frame: Baseline (Day 0) up to Day 14 ]
   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.
3. Change from Baseline in Full Face Cutaneous Tolerance as Assessed by Trained Graders [ Time Frame: Baseline (Day 0) up to Day 14 ]
   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.
4. Change from Baseline in Full Face Cutaneous Tolerance as Assessed by Participants [ Time Frame: Baseline (Day 0) up to Day 14 ]
   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.

Secondary Outcome Measures :

1. Change from Baseline in Clinical Grading of Wound Healing of Edema of a Popped Pimple [ Time Frame: Baseline (Day 0) up to Day 14 ]
   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.
2. Change from Baseline in Clinical Grading of Wound Healing of Crusting/Scabbing of a Popped Pimple [ Time Frame: Baseline (Day 0) up to Day 14 ]
   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.
3. Change from Baseline in Clinical Grading of Wound Healing of Smoothness of a Popped Pimple [ Time Frame: Baseline (Day 0) up to Day 14 ]
   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.
4. Change from Baseline in Clinical Acne Grading of Erythema of a Closed and Popped Pimples [ Time Frame: Baseline (Day 0) up to Day 14 ]
   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.
5. Change from Baseline in Clinical Acne Grading of Size (Diameter) of a Closed and Popped Pimples [ Time Frame: Baseline (Day 0) up to Day 14 ]
   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.
6. Change from Baseline in Clinical Acne Grading of Elevation of a Closed and Popped Pimples [ Time Frame: Baseline (Day 0) up to Day 14 ]
   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.
7. Change from Baseline in Clinical Acne Grading of Dryness/Scaling of a Closed and Popped Pimples [ Time Frame: Baseline (Day 0) up to Day 14 ]
   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.
8. Change from Baseline in Investigator's Global Assessment (IGA) of Acne Severity [ Time Frame: Baseline (Day 0) up to Day 14 ]
   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.
9. Microbiome Analysis of Closed and Popped Pimple [ Time Frame: Baseline (Day 0) and Day 7 ]
   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.
10. Consumer Perception Questionnaire [ Time Frame: Up to Day 13 ]
    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.
11. Standardized Digital Photographs of Full Face [ Time Frame: Baseline (Day 0) up to Day 14 ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 35 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products per instructions, refrain from excessive sunlight and tanning booths/beds, stop all other acne product usage; availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment
• Evidence of a personally signed and dated informed consent or parent/guardian signed and dated informed consent (and/or assent, as applicable) document, Consent for Photograph/Video Release, including Health Insurance Portability and Accountability Act (HIPAA) disclosure, indicating the participant (or legally acceptable representative) has been informed of all pertinent aspects of the trial
• Fitzpatrick Skin Type I to VI
• Generally in good health based on medical history
• Able to read, write, speak, and understand English
• Willing to tell the study staff or principal investigator (PI) about any health problems or new medications that they may start taking during the study
• Must have at least 1 identifiable target inflammatory/closed lesion in the active stage (between 2.0 and 5.0 millimeters [mm] in diameter)
• Must have at least 1 mature inflammatory (to-be-popped) acne lesion (papule or pustule, at least 3 mm in diameter, and capable of being extracted)

Exclusion Criteria:

• Has known allergies or adverse reactions to common topical skincare products, adhesive bandages, latex, wound treatment products, or ingredients in the investigational study materials
• Presents with a skin condition that may influence the outcome of the study, increase risk to the participant, or interfere with study evaluations, in the opinion of the PI (example., severe acne, acne conglobata, psoriasis, atopic dermatitis, eczema, cutaneous xerosis, erythema, active skin cancer, skin dermatoses, keloids, hypertrophic scars, cracked/excoriated skin, pigmentation, friable skin, or clinically infected skin lesions)
• Per Investigator's Global Assessment (IGA) of acne severity score greater than (>) 3 (moderate) according to scale where 0=Clear and 5=Very Severe
• Has a known history of severe systemic immune system disorders
• Has a known history of severe systemic immune system disorders or uncontrolled chronic diseases (such as hypertension, hyperthyroidism, hypothyroidism, or skin cancer within past year)
• Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication
• Is taking medications that would mask an adverse event (AE) or influence the study results, including a) antibiotics, anti-coagulants, antiplatelet drugs, cytotoxic agents, continuous aspirin therapy, chemotherapy, or daily medications for chronic asthma within 1 month before Visit 1; b) immunosuppressive drugs and steroidal and/or non-steroidal anti-inflammatory drugs within 3 months before Visit 1 and during the study; c) antihistamines within 1 month before Visit 1 and during the study
• Is self-reported to be breastfeeding, pregnant or planning to become pregnant during the study
• Has taken/used (oral or topical) vitamin A derivatives such as accutane, isotretinoin, or retinoic acid within 6 months
• Currently taking, of have taken or used on the test area any of the following in the indicated time frame before study enrollment: a) oral or topical prescription medications for acne such as azelaic acid, benzoyl peroxide, Bactrim, clindamycin, dapsone, differin, doxycycline, drospirenone, Epiduo, erythromycin, minocycline, sodium sulfacetamide, spironolactone, tetracycline, and topical tretinoin (adapalene, retin A, renova, tazarotene), vibramycin, within 30 days; b) any systemic medication considered to affect the course of acne, specifically, but not exclusively, antibiotics or steroids, within 30 days. Any topical over-the-counter (OTC) acne products (example, benzoyl peroxide, salicylic acid, and/or alpha/beta/poly-hydroxy products or medicated cleansers, wipes, masks, scrubs, gels and creams) or any facial treatment products containing retinol, retinaldehyde, retinyl esters, salicylic acid, and/or alpha/beta/poly-hydroxy products within 4 weeks
• Has a history of or a concurrent health condition/situation which, in the opinion of the PI or study physician may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
• Is simultaneously participating in any other clinical study or has participate in another clinical study in the past 4 weeks
• Is an employee/contractor or immediate family member of the PI, study site, or sponsor
• Has observable suntan, scars, nevi, tattoo, excessive hair (including beard, mustache, or goatee), or other dermal conditions on the face that that could interfere with study evaluations or confound study results, as determined by the PI or designee
• Coronavirus Disease 2019 (COVID-19): a) history of a confirmed COVID-19 infection in the last 30 days; b) contact with COVID-19-infected person within 14 days prior to enrollment; c) any international travel within 14 days prior to enrollment including members in the same household; d) participants with self-reported COVID-19 symptoms within the past 2 weeks: i) unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomach aches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, fever, or chest pain/tightness; ii) temperature greater than or equal to (>=) 38.0 degree Celsius (°C) /100.4° Fahrenheit (F), measured by thermometer which is adjusted for core temperature; iii) use of fever or pain reducers within the past 2 days of each onsite visit

Contacts and Locations

Locations

United States, Texas

SGS Stephens Inc.

Richardson, Texas, United States, 75081

Sponsors and Collaborators

Johnson & Johnson Consumer Inc. (J&JCI)

Investigators

• Principal Investigator: Summer Acevedo, PhD; Stephens SGS, Inc.

More Information

Additional Information:

Related Info 

Publications:

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.

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.

Mayo Foundation for Medical Education and Research. Acne Treatment. Retrieved from https://www.mayoclinic.org/diseases-conditions/acne/diagnosis-treatment/drc-20368048

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.

• Responsible Party: Johnson & Johnson Consumer Inc. (J&JCI)
• ClinicalTrials.gov Identifier: NCT05012735
• Other Study ID Numbers: CCSTOH003710; CCSTOH003710 ( Other Identifier: Johnson & Johnson Consumer Inc. (J&JCI) )
• First Posted: August 19, 2021
• Last Update Posted: September 16, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.
• URL: http://yoda.yale.edu

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Pantothenic Acid; Provitamins; Vitamins; Micronutrients; Physiological Effects of Drugs; Vitamin B Complex