Atopic Dermatitis (AD)
Conditions
Brief summary
This is a research study. The over-the-counter (OTC) drug for atopic dermatitis being tested is not approved as a treatment for the participants' atopic dermatitis condition. In participating in this study, the investigators will analyze the participants' skin microbiome, measure skin hydration and barrier function, and assess clinical improvements to help us understand the potential impact of the investigational OTC drug on atopic dermatitis and skin microbiome balance.
Interventions
DRUGOTC Drug for Atopic Dermatitis in Cream form
OTC Cosmetic Cream Formulation
Sponsors
Good Molecules, LLC
Sequential Skin Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Previously diagnosed Atopic Dermatitis with active, visible flare-ups at time of screening * Present dry/itchy skin patches on forearm, back of the hand, or posterior lower leg suitable for treatment assessment * Evidence of inflammatory disease (documented diagnosis and current active symptoms) * Stable skincare routine for 4 weeks prior to screening * Subject willing to avoid conflicting topical treatments during study period * Subject being used to applying topical treatments for atopic dermatitis General: * Healthy subject apart from atopic dermatitis * Subject having given free informed, written consent * Subject willing to adhere to protocol and study procedures
Exclusion criteria
* Pregnant or nursing woman or woman planning to get pregnant during the study * Recent (within 4 weeks) or current history of using atopic dermatitis biological drugs, such as dupilumab, lebrikizumab, nemolizumab, and tralokinumab * Recent use of systemic antibiotics, steroids, or immunomodulators (within 4 weeks) * Active skin infections unrelated to atopic dermatitis * Severe dermatologic conditions requiring immediate medical intervention * Use of topical or systemic treatment during previous weeks liable to interfere with assessment * Subject having undergone surgery under general anaesthesia within the previous month * Excessive exposure to sunlight or UV-rays within the previous month * Subject having scars, tattoos on the forearms that would interfere with assessments * Subject enrolled in another clinical trial during the study period and/or during the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin Microbiome Composition and Diversity using qPCR analysis | 4 weeks |
| Trans-Epidermal Water Loss Measurement via Vapometer | 4 weeks |
| Moisturizing effect by measurement of cutaneous hydration via MoistureMeterSC | 4 weeks |
| Skin barrier lipid composition and integrity via lipidomic profiling analysis | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Before and After Treated Arm Itching Assessment | 4 weeks | In vivo clinical grading by a technician using a 11 point scale (0 = uncomfortable, irritated, and 10 = comfortable, soothed) |
| Before and After Treated Arm Redness Assessment | 4 weeks | In vivo clinical grading by a technician using a 5 point scale (0 = absence of redness, and 4 = severe intensity) |
| Before and After Treated Arm Skin Dryness Assessment | 4 weeks | In vivo clinical grading by a technician using a 11 point scale (0 = dry, cracked skin, and 10 = well-hydrated skin) |
| Monitoring of Atopic Dermatitis/Eczema Severity | 4 weeks | Via the Patient Oriented Eczema Measure (POEM) tool |
Countries
United States
Outcome results
None listed