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

NCT04950374 | Withdrawn

• 1 other identifier: CCSSKA003745
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will test the safety and efficacy of 2 moisturizers: a body lotion and a lip moisturizer. For the 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. For the lip moisturizer, the study aims to determine the tolerance of this product by the same study population and its effects on the perceived efficacy. Participants will receive both products and use them at home for 21 +/- 2 days.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (9)

• 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 the lips 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), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.

  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 the lips and score the identified peeling 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), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.

  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 the lips and score the identified blistering 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), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.

  21 ± 2 days

• Change from baseline of the scores to edema to 21 ± 2 days

  At baseline and at 21 ± 2 days, the study physician will evaluate the whole body (including face) and the lips and score the identified edema 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), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.

  21 ± 2 days

• Percentage of participants with Adverse Events through 21 ± 2 days

  The percentage of participants with AEs, serious adverse events (SAEs), AEs leading to discontinuation and AEs related to skin reactions will be evaluated for skin tolerance up to 21 ± 2 days.

  Up to 21 ± 2 days

• Change from baseline of scores of erythema to 5 ± 1 days

  At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and the lips 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), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.

  5 ± 1 days

• Change from baseline of the scores of peeling to 5 ± 1 days

  At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and the lips and score the identified peeling 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), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.

  5 ± 1 days

• Change from baseline of the scores of blistering to 5 ± 1 days

  At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and the lips and score the identified blistering 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), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.

  5 ± 1 days

• Change from baseline of the scores of edema to 5 ± 1 days

  At baseline and at 5 ± 1 days, the study physician will evaluate the whole body (including face) and the lips and score the identified edema 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), and on the lips. The change from baseline will be evaluated to assess skin tolerance of both study products.

  5 ± 1 days

Secondary Outcomes (27)

• Change from baseline of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD) to 21 ± 2 days

  21 ± 2 days

• Change from baseline to 5 ± 1 days of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD)

  5 ± 1 days

• Change from 5 ± 1 days of Atopic Dermatitis severity based on Scoring Atopic Dermatitis Index (SCORAD) to 21 ± 2 days

  5 ± 1 days to 21 ± 2 days

• Mean change from baseline to 21 ± 2 days in skin hydration level of areas with and without AD lesions

  21 ± 2 days

• Mean change from baseline to 5 ± 1 days in skin hydration level of areas with and without AD lesions

  5 ± 1 days

Study Arms (1)

Moisturizer Body Lotion and Lip Moisturizer Regimen

EXPERIMENTAL

All participants will receive and use both products.

Other: Moisturizer Body Lotion; Other: Lip Moisturizer

Interventions

Moisturizer Body Lotion OTHER

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.

Moisturizer Body Lotion and Lip Moisturizer Regimen

Lip Moisturizer OTHER

The lip product is a moisturizing formulation intended for topical use on the lips. It will be applied at least twice daily.

Moisturizer Body Lotion and Lip Moisturizer Regimen

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 dermatological lesions at the initial study 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 and lip moisturizers to the products of this study, and agrees to use them throughout the test period;
• Intends to complete the study and is willing and able to follow all study instructions.

You may not qualify if:

• 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 and hygiene products;
• Subject who has used other leave on moisturizers in the test areas (body, face and lip), 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;

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Related Publications (10)

• 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.

  PMID: 31166406 BACKGROUND

• 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.

  PMID: 19478181 BACKGROUND

• 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.

  PMID: 21697881 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

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

  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.

  PMID: 2459872 BACKGROUND

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

  BACKGROUND

• Brazil. Agência Nacional de Vigilância Sanitária (ANVISA). Guideline for Safety Assessment of Cosmetic Products. 2 edition, 2012.

  BACKGROUND

• Brazil. Agência Nacional de Vigilância Sanitária (ANVISA). Resolution - RDC Nº 10, 03 March 2015.

  BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Mariane M Mosca, Bsc

  Allergisa Pesquisa Dermato-Cosmetica LTDA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: July 6, 2021
• Study Start: July 26, 2021
• Primary Completion: November 26, 2021
• Study Completion: December 10, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share