A Clinical Trial to Evaluate the Safety and Efficacy of a Moisturizer Body Lotion in Adults of Atopic Dermatitis.

Johnson & Johnson (J&J)

Status

Completed

Conditions

Atopic Dermatitis

Treatments

Other: Moisturizer Body Lotion

Study type

Interventional

Funder types

Industry

Identifiers

NCT05062213

CCSSKA004236 (Other Identifier)

Details and patient eligibility

About

This study will evaluate the safety and efficacy of a moisturizer body lotion: the study aims to determine the tolerance of this product by the study population, and its effects on atopic dermatitis condition, skin hydration, skin barrier, skin microbiome and perceived efficacy. Participants will receive the product to use it at home for 21 +/- 2 days.

Enrollment

34 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Fitzpatrick Skin Type I to VI;
Subjects with mild to moderate atopic dermatitis according to the SCORAD index (mild global score (up to 24) and moderate global score (between 25 to 50), presenting areas with AD craracteristic dryness at the initial visit;
Generally in good health based on medical history reported by the subject;
Able to read, write, speak and understand Portuguese;
Person who signed the Consent for Photograph Release and Informed Consent Form;
Person who agrees to change their leave on body moisturizers to the product of this study, and agrees to use it throughout the test period;
Intends to complete the study and is willing and able to follow all study instructions.

Exclusion criteria

Subject who attends the Study Site, on the inclusion visit, with leave on moisturizer applied on the instrumental and microbiome evaluation areas;
Present the need for systemic treatments (as in severe atopic dermatitis cases) such as the use of oral corticosteroids or other types of systemic treatments, as assessed by the Study Physician;
Perform topical antimicrobial therapies (such as sodium hypochlorite bath or use of topical antibiotics);
Perform phototherapy;
Use of antimicrobial / antibacterial / anti germ soaps or other cosmetic / health care and hygiene products;
Subject who has used other leave on moisturizers in the test areas (body and face), with the exception of investigational products, and/or who has changed their hygiene products during the study;
Has known allergies or adverse reactions to common topical skincare products;
Present a skin condition that may influence the outcome of the study (e.g., psoriasis, active skin cancer, etc);
Present skin lesions (e.g., ulcers, vesicles) or tattoos in the test areas, with the exception of lesions associated with mild or moderate atopic dermatitis;
Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication;
Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:

Immunosuppressive drugs within 2 months before Visit 1; Immunobiological drugs within 2 months before visit 1; Topical anti-inflammatory steroids (corticosteroids) within 15 days before the visit 1; Topical and systemic immunomodulators (such as Tacrolimus and Pimecrolimus) within 15 days before visit 1; Topical and systemic antibiotics 15 days before the visit 1; Non-steroidal anti-inflammatory drugs within 15 days before Visit 1 ; Antihistamines within 2 weeks before Visit 1;

Is self-reported to be pregnant or planning to become pregnant during the study;
Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study;
Participating simultaneously in another study;
Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor;
History of a confirmed Coronavirus disease (COVID-19) in the past 30 days;
Contact with a person infected with COVID-19 within 14 days prior to inclusion;
Any international travel within 14 days of inclusion, including members of the same family;
Subjects with self-reported symptoms in the past 2 weeks: unexplained cough, shortness of breath / difficulty breathing, fatigue, body aches (headaches, muscle aches, stomach pains), conjunctivitis, loss of smell, loss of taste, lack of appetite, nausea, vomiting, diarrhea, palpitations, fever or pain / tightness in the chest; temperature ≥ 38.0 degrees Celsius/100.4 degrees Fahrenheit measured; use of fever reducers within the last 2 days of each onsite visit.