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

NCT ID: NCT05062213

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-05-04

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Moisturizer Body Lotion

All participants will receive the product and use it at home.

Group Type: EXPERIMENTAL

Moisturizer Body Lotion

Intervention Type: OTHER

Moisturizer Body Lotion

Interventions

Moisturizer Body Lotion

Moisturizer Body Lotion

Intervention Type: OTHER

Other Intervention Names

The body lotion product is a moisturizing formulation intended for topical use on the whole body and face. It will be applied at least twice daily.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Consumer Inc. (J&JCI)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariane M Mosca, Bsc

Role: PRINCIPAL_INVESTIGATOR

Allergisa Pesquisa Dermato-Cosmetica LTDA

Locations

Allergisa Pesquisa Dermato-Cosmetica Ltda

Campinas, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 31166406 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19478181 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21697881 (View on PubMed)

Stamatas GN, Capone K. New findings, and the impact of infant skin microbiota on product development. Cosmetics and Toiletries

Reference Type: BACKGROUND

Brazil. Conselho Nacional da Saúde. Resolution Nº 466, December 2012.

Reference Type: BACKGROUND

Pan-American Health Organization. Good Clinical Practices: American Document. IV Pan-Americana Conference for Harmonization of Pharmaceutical Regulation, 2005.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 2459872 (View on PubMed)

Agner T, Serup J. Comparison of two electrical methods for measurement of skin hydration. An experimental study on an irritant patch test reaction.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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.

Reference Type: RESULT

PMID: 32484623 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29355894 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25607704 (View on PubMed)

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&parentIdentifier=CCSSKA004236&attachmentIdentifier=a1cfcc6c-5b07-4722-8f21-5a1897ed82a3&fileName=CCSSKA004236_CSR_synopsis.pdf&versionIdentifier=

Single-center, Open-label, Non-randomized Clinical Study to Assess the Safety and Efficacy of a Moisturizing Lotion During and After 21 ± 2 Days of Use in Adult Subjects with Atopic Dermatitis

Other Identifiers

CCSSKA004236

Identifier Type: OTHER

Identifier Source: secondary_id

CCSSKA004236

Identifier Type: -

Identifier Source: org_study_id