Approval Probability
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Adjusted LOA
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Study Cleanser · 1 trial · 1 indication
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 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 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 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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
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 ...
Study Cleanser is an investigational small molecule developed by Johnson & Johnson (ticker JNJ) for acne vulgaris, a dermatology condition. It has been studied in a Phase 1 clinical trial. It is not described as an approved product and remains in clinical development.
Study Cleanser is being studied for acne vulgaris, the common skin condition characterized by pimples. Its only recorded clinical trial enrolled participants with acne vulgaris in the United States. The trial has been completed, and the asset remains in Phase 1 development for this indication.
Study Cleanser is developed by Johnson & Johnson, which trades under the ticker JNJ. Johnson & Johnson is the sponsor associated with the asset's Phase 1 clinical program in acne vulgaris. No other developer or partner is named for this asset.
Study Cleanser is in Phase 1 development. Its single recorded trial, NCT05012735, is a completed Phase 1 study. The program has no active trials at this time, and the asset is investigational rather than an approved treatment.
Study Cleanser has been evaluated in one clinical trial, NCT05012735, titled A Study of a Hydrocolloid Bandage on Pimples. That Phase 1 trial was completed, enrolled 41 participants, was randomized, double blind, and active controlled, and took place in the United States with healthy volunteers aged 12 years and older.