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

Johnson & Johnson (J&J)

Status: Completed

Conditions: Skin Regeneration After Dermatological Facial Procedure With Fractional CO2 Laser

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05272787

CCSSKA004711

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Left face TH Facial Moisturizer

Experimental group

Description:

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.

Treatment:

Other: TH Lip Moisturizer

Other: Facial wash

Other: Sunscreen

Other: TH Facial Moisturizer

Other: Facial Moisturizer B (Control)

Right face TH Facial Moisturizer

Experimental group

Description:

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.

Treatment:

Other: TH Lip Moisturizer

Other: Facial wash

Other: Sunscreen

Other: TH Facial Moisturizer

Other: Facial Moisturizer B (Control)