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

NCT ID: NCT05272787

Last Updated: 2023-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-10
• Study Completion Date: 2022-06-16

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

Study Design

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

Study Groups

Left face TH Facial Moisturizer

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.

Group Type: EXPERIMENTAL

TH Facial Moisturizer

Intervention Type: 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.

TH Lip Moisturizer

Intervention Type: 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.

Facial Moisturizer B (Control)

Intervention Type: 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.

Sunscreen

Intervention Type: OTHER

Auxiliary product

Facial wash

Intervention Type: OTHER

Auxiliary product.

Right face TH Facial Moisturizer

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.

Group Type: EXPERIMENTAL

TH Facial Moisturizer

Intervention Type: 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.

TH Lip Moisturizer

Intervention Type: 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.

Facial Moisturizer B (Control)

Intervention Type: 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.

Sunscreen

Intervention Type: OTHER

Auxiliary product

Facial wash

Intervention Type: OTHER

Auxiliary product.

Interventions

TH Facial Moisturizer

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.

Intervention Type: OTHER

TH Lip Moisturizer

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.

Intervention Type: OTHER

Facial Moisturizer B (Control)

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.

Intervention Type: OTHER

Sunscreen

Auxiliary product

Intervention Type: OTHER

Facial wash

Auxiliary product.

Intervention Type: OTHER

Other Intervention Names

The Facial lotion product is a moisturizing formulation intended for topical use on the half-face. It will be applied at least twice daily.; The lip lotion product is a moisturizing formulation intended for topical use on the lips. It will be applied at least twice daily.; The Facial lotion product is a moisturizing formulation intended for topical use on the half-face. It will be applied at least twice daily.; It will be used all over the face whenever there is the intention of sun exposure.; It will be used to wash the face at least once daily.

Eligibility Criteria

Inclusion Criteria

• Male and/or Female
• 18 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.

Exclusion Criteria

• 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).
• Is simultaneously participating in any other clinical study.
• Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor.
• History of a confirmed COVID-19 infection in the last 30 days.
• Contact with COVID-19-infected person within 14 days prior to all on-site visits.
• Any international travel within 14 days prior to all on-site visits including members in the same household.
• Subjects with self-reported symptoms within the past 2 weeks:
• Unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomach aches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, fever, or chest pain/tightness.
• Temperature ≥ 38.0°C /100.4°F, measured.
• Use of fever reducers within the past 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 Martins Mosca, Bsc.

Role: PRINCIPAL_INVESTIGATOR

Allergisa Pesquisa Dermato-Cosmetica LTDA

Locations

Allergisa Pesquisa Dermato-Cosmetica Ltda

Campinas, São Paulo, Brazil

Countries

Brazil

References

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Reference Type: BACKGROUND

PMID: 27335599 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20808594 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

Other Identifiers

CCSSKA004711

Identifier Type: -

Identifier Source: org_study_id