A Clinical Trial to Evaluate the Safety and Efficacy of a... | NCT05062213

NCT05062213

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
CCSSKA004236	Other Identifier	Johnson & Johnson Consumer Inc.

Status Module

Label	Type	Description	Intervention Names
Moisturizer Body Lotion	Experimental	All participants will receive the product and use it at home.	Other: Moisturizer Body Lotion

Name	Type	Description	Arm Group Labels	Other Names
Moisturizer Body Lotion	Other	Moisturizer Body Lotion	Moisturizer Body Lotion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline of scores of erythema to 21 ± 2 days	At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and score the identified erythemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.	21 ± 2 days
Change from baseline of the scores of peeling to 21 ± 2 days	At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and score the identified peelings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.	21 ± 2 days
Change from baseline of the scores of blistering to 21 ± 2 days	At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and score the identified blisterings according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.	21 ± 2 days
Change from baseline of the scores of edema to 21 ± 2 days	At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and score the identified edemas according to the following intensity scale: 0 (absent); 1 (mild); 2 (moderate); 3 (intense). This scale will be used to classify this skin reaction on the whole body (including face). The change from baseline will be evaluated to assess skin tolerance of the moisturizer body lotion.

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD) to 21 ± 2 days	Atopic dermatitis (AD) severity based on SCORAD Index will be reported at baseline and 21 ± 2 days. The tool involves not only medical assessment, but also subjective symptom assessments reported by the subject. The index is divided into the following parts, which receives a numerical score: Extension (ares with AD lesions); Intensity of reactions (erythema, edema, exudation/crusts, abrasions, lichenification and dry skin; and Subjective Symptoms (pruritus and sleep loss). To evaluate these parameters, a scale from 0 to 10 is used. At the end, a global classification of AD is automatically attributed to each subject. Lower global scores means that less severe is the AD condition. This assessment will be used to determine the effect of the moisturizer body lotion on AD condition of the study population after a period of use.

Eligibility Module

Eligibility Criteria

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.

PubMed Identifier	Type	Citation	Retractions
31166406	Background	Aoki V, Lorenzini D, Orfali RL, Zaniboni MC, Oliveira ZNP, Rivitti-Machado MC, Takaoka R, Weber MB, Cestari T, Gontijo B, Ramos AMC, Silva CMR, Cestari SDCP, Souto-Mayor S, Carneiro FR, Cerqueira AMM, Laczynski C, Pires MC. Consensus on the therapeutic management of atopic dermatitis - Brazilian Society of Dermatology. An Bras Dermatol. 2019 Apr;94(2 Suppl 1):67-75. doi: 10.1590/abd1806-4841.2019940210. Epub 2019 Jun 3.
19478181

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis