An Evaluation of the Safety and Efficacy of a Hydrocolloid Bandage on Pimples
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change from Baseline in General Wound Appearance Score of the Popped Pimple
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and tolerability of a hydrocolloid bandage on pimples when used overnight for one week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Study Cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5) (Drug)
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.
干预措施: Prototype Ultrathin Hydrocolloid Bandage (Device)
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.
干预措施: Study Cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5) (Drug)
结局指标
主要结局
Change from Baseline in General Wound Appearance Score of the Popped Pimple
时间窗: 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.
Change from Baseline in Full Face Cutaneous Tolerance as Assessed by Trained Graders
时间窗: 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.
Percentage of Healed Popped Pimples
时间窗: 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.
Change from Baseline in Full Face Cutaneous Tolerance as Assessed by Participants
时间窗: 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.
次要结局
- Change from Baseline in Clinical Acne Grading of Size (Diameter) of a Closed and Popped Pimples(Baseline (Day 0) up to Day 14)
- Change from Baseline in Clinical Acne Grading of Erythema of a Closed and Popped Pimples(Baseline (Day 0) up to Day 14)
- Change from Baseline in Clinical Acne Grading of Elevation of a Closed and Popped Pimples(Baseline (Day 0) up to Day 14)
- Change from Baseline in Clinical Acne Grading of Dryness/Scaling of a Closed and Popped Pimples(Baseline (Day 0) up to Day 14)
- Change from Baseline in Investigator's Global Assessment (IGA) of Acne Severity(Baseline (Day 0) up to Day 14)
- Change from Baseline in Clinical Grading of Wound Healing of Edema of a Popped Pimple(Baseline (Day 0) up to Day 14)
- Change from Baseline in Clinical Grading of Wound Healing of Crusting/Scabbing of a Popped Pimple(Baseline (Day 0) up to Day 14)
- Change from Baseline in Clinical Grading of Wound Healing of Smoothness of a Popped Pimple(Baseline (Day 0) up to Day 14)
- Microbiome Analysis of Closed and Popped Pimple(Baseline (Day 0) and Day 7)
- Consumer Perception Questionnaire(Up to Day 13)
- Standardized Digital Photographs of Full Face(Baseline (Day 0) up to Day 14)