Clinical trial NCT05012735: A Study of a Hydrocolloid Bandage on Pimples
Official title: An Evaluation of the Safety and Efficacy of a Hydrocolloid Bandage on Pimples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2021-08-19
Enrollment: 41
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from Baseline in General Wound Appearance Score of the Popped Pimple
timeFrame: Baseline (Day 0) up to Day 14
measure: Percentage of Healed Popped Pimples
timeFrame: Baseline (Day 0) up to Day 14
measure: Change from Baseline in Full Face Cutaneous Tolerance as Assessed by Trained Graders
timeFrame: Baseline (Day 0) up to Day 14
measure: Change from Baseline in Full Face Cutaneous Tolerance as Assessed by Participants
timeFrame: Baseline (Day 0) up to Day 14
Secondary outcomes:
measure: Change from Baseline in Clinical Grading of Wound Healing of Edema of a Popped Pimple
timeFrame: Baseline (Day 0) up to Day 14
measure: Change from Baseline in Clinical Grading of Wound Healing of Crusting/Scabbing of a Popped Pimple
timeFrame: Baseline (Day 0) up to Day 14
measure: Change from Baseline in Clinical Grading of Wound Healing of Smoothness of a Popped Pimple
timeFrame: Baseline (Day 0) up to Day 14
measure: Change from Baseline in Clinical Acne Grading of Erythema of a Closed and Popped Pimples
timeFrame: Baseline (Day 0) up to Day 14
measure: Change from Baseline in Clinical Acne Grading of Size (Diameter) of a Closed and Popped Pimples
timeFrame: Baseline (Day 0) up to Day 14
measure: Change from Baseline in Clinical Acne Grading of Elevation of a Closed and Popped Pimples
timeFrame: Baseline (Day 0) up to Day 14
measure: Change from Baseline in Clinical Acne Grading of Dryness/Scaling of a Closed and Popped Pimples
timeFrame: Baseline (Day 0) up to Day 14
measure: Change from Baseline in Investigator's Global Assessment (IGA) of Acne Severity
timeFrame: Baseline (Day 0) up to Day 14
measure: Microbiome Analysis of Closed and Popped Pimple
timeFrame: Baseline (Day 0) and Day 7
measure: Consumer Perception Questionnaire
timeFrame: Up to Day 13
measure: Standardized Digital Photographs of Full Face
timeFrame: Baseline (Day 0) up to Day 14
Other outcomes:
Locations:
city: Richardson
country: United States
facility: SGS Stephens Inc.
state: Texas
Study officials:
affiliation: Stephens SGS, Inc.
name: Summer Acevedo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Mayo Foundation for Medical Education and Research. Acne Treatment. Retrieved from https://www.mayoclinic.org/diseases-conditions/acne/diagnosis-treatment/drc-20368048
citation: 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.