Clinical trial NCT05062213: A Clinical Trial to Evaluate the Safety and Efficacy of a Moisturizer Body Lotion in Adults of Atopic Dermatitis.
Official title: Single Center, Open-label, Non-randomized Clinical Trial to Evaluate the Safety and Efficacy of a Moisturizer Body Lotion During and After 21 ± 2 Days of Use in Adults With Atopic Dermatitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2021-09-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


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.

Primary outcomes:
measure: Change from baseline of scores of erythema to 21 ± 2 days
timeFrame: 21 ± 2 days
measure: Change from baseline of the scores of peeling to 21 ± 2 days
timeFrame: 21 ± 2 days
measure: Change from baseline of the scores of blistering to 21 ± 2 days
timeFrame: 21 ± 2 days
measure: Change from baseline of the scores of edema to 21 ± 2 days
timeFrame: 21 ± 2 days
measure: Percentage of participants with Adverse Events through 21 ± 2 days
timeFrame: Up to 21 ± 2 days
measure: Change from baseline of scores of erythema to 5 ± 1 days
timeFrame: 5 ± 1 days
measure: Change from baseline of the scores of peeling to 5 ± 1 days
timeFrame: 5 ± 1 days
measure: Change from baseline of the scores of blistering to 5 ± 1 days
timeFrame: 5 ± 1 days
measure: Change from baseline of the scores of edema to 5 ± 1 days
timeFrame: 5 ± 1 days
Secondary outcomes:
measure: Change from baseline of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD) to 21 ± 2 days
timeFrame: 21 ± 2 days
measure: Change from baseline to 5 ± 1 days of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD)
timeFrame: 5 ± 1 days
measure: Change from 5 ± 1 days of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD) to 21 ± 2 days
timeFrame: 5 ± 1 days to 21 ± 2 days
measure: Mean change from baseline to 21 ± 2 days in skin hydration level of areas with and without AD characteristic dryness
timeFrame: 21 ± 2 days
measure: Mean change from baseline to 5 ± 1 days in skin hydration level of areas with and without AD characteristic dryness
timeFrame: 5 ± 1 days
measure: Mean change from 5 ± 1 days to 21 ± 2 days in skin hydration level of areas with and without AD characteristic dryness
timeFrame: 5 ± 1 days to 21 ± 2 days
measure: Mean change from baseline to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD characteristic dryness
timeFrame: 21 ± 2 days
measure: Mean change from baseline to 5 ± 1 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD characteristic dryness
timeFrame: 5 ± 1 days
measure: Mean change from 5 ± 1 days to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity of areas with and without AD characteristic dryness
timeFrame: 5 ± 1 days to 21 ± 2 days
measure: Mean change from baseline to 21 ± 2 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity
timeFrame: 21 ± 2 days
measure: Mean change from baseline to 7 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity
timeFrame: 7 days
measure: Mean change from baseline to 14 days in the Patient-Oriented Eczema Measure (POEM) total score to assess AD severity
timeFrame: 14 days
measure: Perceived Efficacy of the quality of life at baseline
timeFrame: Baseline
measure: Perceived Efficacy in the quality of life at 7 days
timeFrame: 7 days
measure: Perceived Efficacy in the quality of life at 14 days
timeFrame: 14 days
measure: Perceived Efficacy in the quality of life at 21 ± 2 days
timeFrame: 21 ± 2 days
measure: Perceived Efficacy of the moisturizer body lotion at 7 days
timeFrame: 7 days
measure: Perceived Efficacy of the moisturizer body lotion at 14 days
timeFrame: 14 days
measure: Perceived Efficacy of the moisturizer body lotion at 21 ± 2 days
timeFrame: 21 ± 2 days
measure: Determination of types and quantity of bacteria (skin microbiome) of areas with and without AD characteristic dryness at baseline
timeFrame: Baseline
measure: Determination of types and quantity of bacteria (skin microbiome) of areas with and without AD characteristic dryness at 21 ± 2 days
timeFrame: 21 ± 2 days
measure: Visual skin condition of areas with and without AD characteristic dryness at baseline captured photographically
timeFrame: Baseline
measure: Visual skin condition of areas with and without AD characteristic dryness at 5 ± 1 days captured photographically
timeFrame: 5 ± 1 days
measure: Visual skin condition of areas with and without AD characteristic dryness at 21 ± 2 days captured photographically
timeFrame: 21 ± 2 days
measure: Testimonial regarding the experience with moisturizer body lotion at 21 ± 2 days
timeFrame: 21 ± 2 days
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa Pesquisa Dermato-Cosmetica Ltda
state: São Paulo
Study officials:
affiliation: Allergisa Pesquisa Dermato-Cosmetica LTDA
name: Mariane M Mosca, Bsc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;324(5931):1190-2. doi: 10.1126/science.1171700.
citation: Gallo RL, Nakatsuji T. Microbial symbiosis with the innate immune defense system of the skin. J Invest Dermatol. 2011 Oct;131(10):1974-80. doi: 10.1038/jid.2011.182. Epub 2011 Jun 23.
citation: Stamatas GN, Capone K. New findings, and the impact of infant skin microbiota on product development. Cosmetics and Toiletries
citation: Brazil. Conselho Nacional da Saúde. Resolution Nº 466, December 2012.
citation: Pan-American Health Organization. Good Clinical Practices: American Document. IV Pan-Americana Conference for Harmonization of Pharmaceutical Regulation, 2005.
citation: Blichmann CW, Serup J. Assessment of skin moisture. Measurement of electrical conductance, capacitance and transepidermal water loss. Acta Derm Venereol. 1988;68(4):284-90.
citation: Agner T, Serup J. Comparison of two electrical methods for measurement of skin hydration. An experimental study on an irritant patch test reaction.
citation: Chow SH, Shao J, Wang H. Sample Size Calculation in Clinical Research. 2ª Edição. Taylor and Francis Group, LLC, 2008.
citation: Capone K, Kirchner F, Klein SL, Tierney NK. Effects of Colloidal Oatmeal Topical Atopic Dermatitis Cream on Skin Microbiome and Skin Barrier Properties. J Drugs Dermatol. 2020 May 1;19(5):524-531.
citation: Howells L, Ratib S, Chalmers JR, Bradshaw L, Thomas KS; CLOTHES trial team. How should minimally important change scores for the Patient-Oriented Eczema Measure be interpreted? A validation using varied methods. Br J Dermatol. 2018 May;178(5):1135-1142. doi: 10.1111/bjd.16367. Epub 2018 Apr 17.
citation: Seite S, Flores GE, Henley JB, Martin R, Zelenkova H, Aguilar L, Fierer N. Microbiome of affected and unaffected skin of patients with atopic dermatitis before and after emollient treatment. J Drugs Dermatol. 2014 Nov;13(11):1365-72.