Clinical Trial to Evaluate Safety and Efficacy of a Facial and Lip Moisturizer in Adult Subjects Undergoing a Facial Dermatologic Procedure With Fractional CO2 Laser

NCT05272787 | Completed

• 1 other identifier: CCSSKA004711
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is study aims to evaluate the topical safety (tolerability/acceptability) and efficacy of TH Facial Moisturizer and TH Lip Moisturizer Investigational products after 21 ± 2 days of use under normal conditions on the half-face by adult participants who underwent dermatological facial procedure with fractional CO2 Laser under the supervision of a dermatologist. For these investigational products, safety parameters, clinical efficacy, instrumental efficacy (skin hydration, skin barrier integrity and facial imaging) and perceived efficacy through subjective perception questionnaires will be evaluated. Subjects will receive the product to use it at home for 21 +/- 2 days.

Conditions

Skin Regeneration After Dermatological Facial Procedure With Fractional CO2 Laser

Outcome Measures

Primary Outcomes (5)

• 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 face (including 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 face (including lips). The change from baseline will be evaluated to assess skin tolerance of the TH Facial moiturizer and TH Lip moisturizer.

  21 ± 2 days.

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

  At baseline and at 21 ± 2 days, the study physician will evaluate the whole face (including lips) and score the identified desquamations 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 face (including lips). The change from baseline will be evaluated to assess skin tolerance of the TH Facial moiturizer and TH Lip moisturizer.

  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 face (including lips) 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 face (including lips). The change from baseline will be evaluated to assess skin tolerance of the TH Facial moiturizer and TH Lip moisturizer.

  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 face (including lips) 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 face (including lips). The change from baseline will be evaluated to assess skin tolerance of the TH Facial moiturizer and TH Lip moisturizer.

  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.

  21 ± 2 days.

Secondary Outcomes (117)

• Change from baseline of the scores of erythema to 21 ± 2 days for TH facial moisturizer.

  21 ± 2 days.

• Change from baseline of the scores of erythema to 21 ± 2 days for Facial Moisturizer B (Control).

  21 ± 2 days.

• Comparison of erythema scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)

  21 ± 2 days.

• Change from baseline of the scores of erythema to 5 ± 1 day for TH facial moisturizer.

  5 ± 1 day.

• Change from baseline of the scores of erythema to 5 ± 1 day for Facial Moisturizer B (Control).

  5 ± 1 day.

Study Arms (2)

Left face TH Facial Moisturizer

EXPERIMENTAL

All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home. The choice of the half face on which the product will be applied will be defined by a randomization list, prepared by the statistician in charge. If the TH Facial Moisturizer will be applied on the left side of the face, then the Facial Moisturizer B (Control) will be applied on the right side of the face. Lip moisturizer, facial wash and sunscreen will be applied in all arms of the study.

Other: TH Facial Moisturizer; Other: TH Lip Moisturizer; Other: Facial Moisturizer B (Control); Other: Sunscreen; Other: Facial wash

Right face TH Facial Moisturizer

EXPERIMENTAL

All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home. The choice of the half face on which the product will be applied will be defined by a randomization list, prepared by the statistician in charge. If the TH Facial Moisturizer will be applied on the right side of the face, then the Facial Moisturizer B (Control) will be applied on the left side of the face. Lip moisturizer, facial wash and sunscreen will be applied in all arms of the study.

Other: TH Facial Moisturizer; Other: TH Lip Moisturizer; Other: Facial Moisturizer B (Control); Other: Sunscreen; Other: Facial wash

Interventions

TH Facial Moisturizer OTHER

All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home.

Also known as: The Facial lotion product is a moisturizing formulation intended for topical use on the half-face. It will be applied at least twice daily.

Left face TH Facial Moisturizer; Right face TH Facial Moisturizer

TH Lip Moisturizer OTHER

All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home.

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

Left face TH Facial Moisturizer; Right face TH Facial Moisturizer

Facial Moisturizer B (Control) OTHER

All subjects will receive all the products. There will be a supervised application at the site on the baseline visit of the study. Then subjects will use all the products at home.

Also known as: The Facial lotion product is a moisturizing formulation intended for topical use on the half-face. It will be applied at least twice daily.

Left face TH Facial Moisturizer; Right face TH Facial Moisturizer

Sunscreen OTHER

Auxiliary product

Also known as: It will be used all over the face whenever there is the intention of sun exposure.

Left face TH Facial Moisturizer; Right face TH Facial Moisturizer

Facial wash OTHER

Auxiliary product.

Also known as: It will be used to wash the face at least once daily.

Left face TH Facial Moisturizer; Right face TH Facial Moisturizer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and/or Female
• to 65 years old
• Fitzpatrick Skin Type I to III
• Generally in good health based on medical history reported by the subject.
• Subjects presenting dry/dried up lips, proven by dermatologist.
• Subjects who have some cutaneous condition whose performance of the Fractional CO2 Laser procedure is recommended by the dermatologist, for example facial spots and/or acne scars and/or facial wrinkles.
• Able to read, write, speak, and understand Portuguese.
• Individual has signed the ICD.
• Agree to the performance of the Fractional CO2 Laser procedure by the dermatologist.
• Agree to use two facial products, each on one half face, and one lip product.
• Agree to use the facial sunscreen provided during the conditioning period and during sun exposure.
• Agree to replace their usual facial wash with the facial wash provided for facial cleansing during the conditioning period and during the study.
• For male participants: agree to shave the day before visits 2, 4 and 5.
• Intends to complete the study and is willing and able to follow all study instructions.

You may not qualify if:

• Has known allergies or adverse reactions to common topical skincare products including facial moisturizer, sunscreen and liquid soap.
• Have known allergies or adverse reactions to the Pliaglis anesthetic cream that will be used for the dermatological facial procedure.
• Presents with a skin condition that may confound the study results (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer).
• Presents with primary/secondary lesions (scar - except from acne, ulcers, vesicles) or tattoos on test sites.
• 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 or steroidal drugs within 2 months before Visit 1\*
• Non-steroidal anti-inflammatory drugs within 5 days before Visit 1\*
• Antihistamines within 2 weeks before Visit 1\*
• \* If an individual is taking one of these medication types, the individual is not considered eligible at screening. However, if a subject begins using one of these medications during the study, the Study Physician should be consulted to consider the impact of the specific medication on subject safety and/or the study results, as described in section "Concurrent/Concomitant Medication".
• Is self-reported to be pregnant or planning to become pregnant during the study.
• Subjects with a history of keloid formation.
• Subject with a history of Herpes.
• 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.
• Test positive for COVID-19 at visit 2 according to the rapid antigen test (COVID-19 Ag Immuno-Rapid Kit).

Sponsors & Collaborators

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

Study Sites (1)

Allergisa Pesquisa Dermato-Cosmetica Ltda

Campinas, São Paulo, 13084-791, Brazil

Location

Related Publications (12)

• Petrov A. Efficiency of Carbon Dioxide Fractional Laser in Skin Resurfacing. Open Access Maced J Med Sci. 2016 Jun 15;4(2):271-6. doi: 10.3889/oamjms.2016.062. Epub 2016 May 24.

  PMID: 27335599 BACKGROUND

• Krupa Shankar D, Chakravarthi M, Shilpakar R. Carbon dioxide laser guidelines. J Cutan Aesthet Surg. 2009 Jul;2(2):72-80. doi: 10.4103/0974-2077.58519.

  PMID: 20808594 BACKGROUND

• Zahr AS, Kononov T, Sensing W, Biron JA, Gold MH. An open-label, single-site study to evaluate the tolerability, safety, and efficacy of using a novel facial moisturizer for preparation and accelerated healing pre and post a single full-face radiofrequency microneedling treatment. J Cosmet Dermatol. 2019 Feb;18(1):94-106. doi: 10.1111/jocd.12817. Epub 2018 Nov 19.

  PMID: 30456804 BACKGROUND

• ASSOCIAÇÃO MÉDICA MUNDIAL. Declaração de Helsinque. Princípios Éticos para Pesquisa Médica Envolvendo Participantes Humanos.Princípios Éticos para Pesquisa Médica Envolvendo Participantes Humanos.

  BACKGROUND

• BRASIL. Ministério da Saúde. RDC nº 466, de 12 de dezembro 2012. Aprova diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos.

  BACKGROUND

• Canfield Scientific. Visia CR: Facial Imaging System for Clinical Research. The Measuring Principle.

  BACKGROUND

• Courage + Khazaka electronic GmbH. Corneometer® CM 825. The Measuring Principle.

  BACKGROUND

• Courage + Khazaka electronic GmbH. Tewameter® TM 300. The Measuring Principle.

  BACKGROUND

• Courage + Khazaka electronic GmbH. Tewameter® TM Nano. The Measuring Principle.

  BACKGROUND

• International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use.. ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001 Jan-Mar;47(1):45-50. No abstract available.

  PMID: 11590294 BACKGROUND

• OPAS. Organização Pan-Americana de Saúde. Boas Práticas Clínicas: Documento das Américas. IV Conferência Pan-Americana para Harmonização da Regulamentação Farmacêutica, 2005.

  BACKGROUND

• WAMA Diagnóstica. Guia para o teste rápido de antígeno: Kit Imuno-Rápido COVID-19 Ag. 2021.

  BACKGROUND

MeSH Terms

Interventions

Sunscreening Agents

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals

Study Officials

• Mariane Martins Mosca, Bsc.

  Allergisa Pesquisa Dermato-Cosmetica LTDA

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: All participants will receive the same study regimen consisting of 5 products: a facial moisturizer, a facial moisturizer (control), a lip moisturizer, a sunscreen and a facial wash.The facial moisturizers will be applied on the half face. The choice of the half face on which the product will be applied will be defined by a randomization list, prepared by the statistician in charge.

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 9, 2022
• Study Start: March 10, 2022
• Primary Completion: April 13, 2022
• Study Completion: June 16, 2022
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)