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Phase 1

Acne Vulgaris | Small molecule | Dermatology |Johnson & Johnson|Last Updated: Sep 16, 2022

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

Study Cleanser · 1 trial · 1 indication

Phase 1 1
NCT05012735A Study of a Hydrocolloid Bandage on PimplesAcne Vulgaris
COMPLETED41 Analytics
PHASE1COMPLETED
A Study of a Hydrocolloid Bandage on Pimples
Acne VulgarisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline in General Wound Appearance Score of the Popped Pimple
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.

Percentage of Healed Popped Pimples
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 Trained Graders
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.

Change from Baseline in Full Face Cutaneous Tolerance as Assessed by Participants
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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Group: Prototype Ultrathin Hydrocolloid Bandage and Study CleanserEXPERIMENTALParticipants 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.
Control Group: Study Cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5)ACTIVE_COMPARATORParticipants will wash their face twice daily using the study cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5) for up to 14 days.

Interventions

NameTypeDescription
Study Cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5)DRUGParticipants will wash their face with the study cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5) for up to 14 days.
Prototype Ultrathin Hydrocolloid BandageDEVICEParticipants will cover their closed and popped pimples in the evening with one or two bandages from Days 0 through 6.
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Eligibility Criteria

Age Range12 Years to 35 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:United States
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