Clinical trial NCT05272787: 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
Official title: A Single-Center, Open-Label, Randomized Safety-in-Use Clinical Study to Assess the Topical Tolerability and Efficacy of a Facial Moisturizer and Lip Moisturizer During and After 21±2 Days of Use in Adult Subjects Undergoing a Facial Dermatologic Procedure With Fractional CO2 Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Regeneration After Dermatological Facial Procedure With Fractional CO2 Laser
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2022-03-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Change from baseline of scores of erythema to 21 ± 2 days.
timeFrame: 21 ± 2 days.
measure: Change from baseline of the scores of desquamation to 21 ± 2 days.
timeFrame: 21 ± 2 days.
measure: Change from baseline of the scores of blistering to 21 ± 2 days.
timeFrame: 21 ± 2 days.
measure: Change from baseline of the scores of edema to 21 ± 2 days.
timeFrame: 21 ± 2 days.
measure: Percentage of participants with Adverse Events through 21 ± 2 days.
timeFrame: 21 ± 2 days.
Secondary outcomes:
measure: Change from baseline of the scores of erythema to 21 ± 2 days for TH facial moisturizer.
timeFrame: 21 ± 2 days.
measure: Change from baseline of the scores of erythema to 21 ± 2 days for Facial Moisturizer B (Control).
timeFrame: 21 ± 2 days.
measure: Comparison of erythema scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: 21 ± 2 days.
measure: Change from baseline of the scores of erythema to 5 ± 1 day for TH facial moisturizer.
timeFrame: 5 ± 1 day.
measure: Change from baseline of the scores of erythema to 5 ± 1 day for Facial Moisturizer B (Control).
timeFrame: 5 ± 1 day.
measure: Comparison of erythema scores at5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 5 ± 1 day.
measure: Change from baseline of the scores of erythema to 24 hours for TH facial moisturizer.
timeFrame: 24 hours.
measure: Change from baseline of the scores of erythema to 24 hours for Facial Moisturizer B (Control).
timeFrame: 24 hours.
measure: Comparison of erythema scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 24 hours.
measure: Change from baseline of the scores of erythema to 1 hour for TH facial moisturizer.
timeFrame: 1 hour.
measure: Change from baseline of the scores of erythema to 1 hour for Facial Moisturizer B (Control).
timeFrame: 1 hour.
measure: Comparison of erythema scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 1 hour.
measure: Change from baseline of the scores of erythema to 30 minutes for TH facial moisturizer.
timeFrame: 30 minutes.
measure: Change from baseline of the scores of erythema to 30 minutes for Facial Moisturizer B (Control).
timeFrame: 30 minutes.
measure: Comparison of erythema scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 30 minutes.
measure: Change from baseline of the scores of edema to 21 ± 2 days for TH facial moisturizer.
timeFrame: 21 ± 2 days.
measure: Change from baseline of the scores of edema to 21 ± 2 days for Facial Moisturizer B (Control).
timeFrame: 21 ± 2 days.
measure: Comparison of edema scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 21 ± 2 days.
measure: Change from baseline of the scores of edema to 5 ± 1 day for TH facial moisturizer.
timeFrame: 5 ± 1 day.
measure: Change from baseline of the scores of edema to 5 ± 1 day for Facial Moisturizer B (Control).
timeFrame: 5 ± 1 day.
measure: Comparison of edema scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 5 ± 1 day.
measure: Change from baseline of the scores of edema to 24 hours for TH facial moisturizer.
timeFrame: 24 hours.
measure: Change from baseline of the scores of edema to 24 hours for Facial Moisturizer B (Control).
timeFrame: 24 hours.
measure: Comparison of edema scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 24 hours.
measure: Change from baseline of the scores of edema to 1 hour for TH facial moisturizer.
timeFrame: 1 hour.
measure: Change from baseline of the scores of edema to 1 hour for Facial Moisturizer B (Control).
timeFrame: 1 hour.
measure: Comparison of edema scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 1 hour.
measure: Change from baseline of the scores of edema to 30 minutes for TH facial moisturizer.
timeFrame: 30 minutes.
measure: Change from baseline of the scores of edema to 30 minutes for Facial Moisturizer B (Control).
timeFrame: 30 minutes.
measure: Comparison of edema scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 30 minutes.
measure: Change from baseline of the scores of dryness to 21 ± 2 days for TH facial moisturizer.
timeFrame: 21 ± 2 days.
measure: Change from baseline of the scores of dryness to 21 ± 2 days for Facial Moisturizer B (Control).
timeFrame: 21 ± 2 days.
measure: Comparison of dryness scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 21 ± 2 days.
measure: Change from baseline of the scores of dryness to 5 ± 1 day for TH facial moisturizer.
timeFrame: 5 ± 1 day.
measure: Change from baseline of the scores of dryness to 5 ± 1 day for Facial Moisturizer B (Control).
timeFrame: 5 ± 1 day.
measure: Comparison of dryness scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 5 ± 1 day.
measure: Change from baseline of the scores of dryness to 24 hours for TH facial moisturizer.
timeFrame: 24 hours.
measure: Change from baseline of the scores of dryness to 24 hours for Facial Moisturizer B (Control).
timeFrame: 24 hours.
measure: Comparison of dryness scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 24 hours.
measure: Change from baseline of the scores of dryness to 1 hour for TH facial moisturizer.
timeFrame: 1 hour.
measure: Change from baseline of the scores of dryness to 1 hour for Facial Moisturizer B (Control).
timeFrame: 1 hour.
measure: Comparison of dryness scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 1 hour.
measure: Change from baseline of the scores of dryness to 30 minutes for TH facial moisturizer.
timeFrame: 30 minutes.
measure: Change from baseline of the scores of dryness to 30 minutes for Facial Moisturizer B (Control).
timeFrame: 30 minutes.
measure: Comparison of dryness scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 30 minutes.
measure: Change from baseline of the scores of desquamation to 21 ± 2 days for TH facial moisturizer.
timeFrame: 21 ± 2 days.
measure: Change from baseline of the scores of desquamation to 21 ± 2 days for Facial Moisturizer B (Control).
timeFrame: 21 ± 2 days.
measure: Comparison of desquamation scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 21 ± 2 days.
measure: Change from baseline of the scores of desquamation to 5 ± 1 day for TH facial moisturizer.
timeFrame: 5 ± 1 day.
measure: Change from baseline of the scores of desquamation to 5 ± 1 day for Facial Moisturizer B (Control).
timeFrame: 5 ± 1 day.
measure: Comparison of desquamation scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 5 ± 1 day.
measure: Change from baseline of the scores of desquamation to 24 hours for TH facial moisturizer.
timeFrame: 24 hours.
measure: Change from baseline of the scores of desquamation to 24 hours for Facial Moisturizer B (Control).
timeFrame: 24 hours.
measure: Comparison of desquamation scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 24 hours.
measure: Change from baseline of the scores of desquamation to 1 hour for TH facial moisturizer.
timeFrame: 1 hour.
measure: Change from baseline of the scores of desquamation to 1 hour for Facial Moisturizer B (Control).
timeFrame: 1 hour.
measure: Comparison of desquamation scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 1 hour.
measure: Change from baseline of the scores of desquamation to 30 minutes for TH facial moisturizer.
timeFrame: 30 minutes.
measure: Change from baseline of the scores of desquamation to 30 minutes for Facial Moisturizer B (Control).
timeFrame: 30 minutes.
measure: Comparison of desquamation scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 30 minutes.
measure: Change from baseline of the scores of stinging to 21 ± 2 days for TH facial moisturizer.
timeFrame: 21 ± 2 days.
measure: Change from baseline of the scores of stinging to 21 ± 2 days for Facial Moisturizer B (Control).
timeFrame: 21 ± 2 days.
measure: Comparison of stinging scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 21 ± 2 days.
measure: Change from baseline of the scores of stinging to 5 ± 1 day for TH facial moisturizer.
timeFrame: 5 ± 1 day.
measure: Change from baseline of the scores of stinging to 5 ± 1 day for Facial Moisturizer B (Control).
timeFrame: 5 ± 1 day.
measure: Comparison of stinging scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 5 ± 1 day.
measure: Change from baseline of the scores of stinging to 24 hours for TH facial moisturizer.
timeFrame: 24 hours.
measure: Change from baseline of the scores of stinging to 24 hours for Facial Moisturizer B (Control).
timeFrame: 24 hours.
measure: Comparison of stinging scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 24 hours.
measure: Change from baseline of the scores of stinging to 1 hour for TH facial moisturizer.
timeFrame: 1 hour.
measure: Change from baseline of the scores of stinging to 1 hour for Facial Moisturizer B (Control).
timeFrame: 1 hour.
measure: Comparison of stinging scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 1 hour.
measure: Change from baseline of the scores of stinging to 30 minutes for TH facial moisturizer.
timeFrame: 30 minutes.
measure: Change from baseline of the scores of stinging to 30 minutes for Facial Moisturizer B (Control).
timeFrame: 30 minutes.
measure: Comparison of stinging scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 30 minutes.
measure: Change from baseline of the scores of itching to 21 ± 2 days for TH facial moisturizer.
timeFrame: 21 ± 2 days.
measure: Change from baseline of the scores of itching to 21 ± 2 days for Facial Moisturizer B (Control).
timeFrame: 21 ± 2 days.
measure: Comparison of itching scores at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 21 ± 2 days.
measure: Change from baseline of the scores of itching to 5 ± 1 day for TH facial moisturizer.
timeFrame: 5 ± 1 day.
measure: Change from baseline of the scores of itching to 5 ± 1 day for Facial Moisturizer B (Control).
timeFrame: 5 ± 1 day.
measure: Comparison of itching scores at 5 ± 1 day between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 5 ± 1 day.
measure: Change from baseline of the scores of itching to 24 hours for TH facial moisturizer.
timeFrame: 24 hours.
measure: Change from baseline of the scores of itching to 24 hours for Facial Moisturizer B (Control).
timeFrame: 24 hours.
measure: Comparison of itching scores at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 24 hours.
measure: Change from baseline of the scores of itching to 1 hour for TH facial moisturizer.
timeFrame: 1 hour.
measure: Change from baseline of the scores of itching to 1 hour for Facial Moisturizer B (Control).
timeFrame: 1 hour.
measure: Comparison of itching scores at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 1 hour.
measure: Change from baseline of the scores of itching to 30 minutes for TH facial moisturizer.
timeFrame: 30 minutes.
measure: Change from baseline of the scores of itching to 30 minutes for Facial Moisturizer B (Control).
timeFrame: 30 minutes.
measure: Comparison of itching scores at 30 minutes between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 30 minutes.
measure: Self-Perceived Efficacy Questionnaire at 30 minutes
timeFrame: 30 minutes
measure: Self-Perceived Efficacy Questionnaire at 24 hours
timeFrame: 24 hours
measure: Self-Perceived Efficacy Questionnaire at 5 ± 1 day
timeFrame: 5 ± 1 day
measure: Self-Perceived Efficacy Questionnaire at 21 ± 2 days
timeFrame: 21 ± 2 days
measure: Visual skin condition of the whole face at baseline captured photographically
timeFrame: baseline
measure: Visual skin condition of the whole face at 1 hour captured photographically
timeFrame: 1 hour
measure: Visual skin condition of the whole face at 24 hours captured photographically
timeFrame: 24 hours
measure: Visual skin condition of the whole face at 5 ± 1 day captured photographically
timeFrame: 5 ± 1 day
measure: Visual skin condition of the whole face at 21 ± 2 days captured photographically
timeFrame: 21 ± 2 days
measure: Mean change from baseline to 21 ± 2 days in skin hydration level for TH facial moisturizer.
timeFrame: 21 ± 2 days
measure: Mean change from baseline to 21 ± 2 days in skin hydration level for Facial Moisturizer B (Control).
timeFrame: 21 ± 2 days
measure: Comparison of skin hydration level at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 21 ± 2 days.
measure: Mean change from baseline to 24 hours in skin hydration level for TH facial moisturizer.
timeFrame: 24 hours
measure: Mean change from baseline to 24 hours in skin hydration level for Facial Moisturizer B (Control).
timeFrame: 24 hours
measure: Comparison of skin hydration level at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 24 hours.
measure: Mean change from baseline to 1 hour in skin hydration level for TH facial moisturizer.
timeFrame: 1 hour
measure: Mean change from baseline to 1 hour in skin hydration level for Facial Moisturizer B (Control).
timeFrame: 1 hour
measure: Comparison of skin hydration level at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 1 hour
measure: Mean change from baseline to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity for TH facial moisturizer.
timeFrame: 21 ± 2 days
measure: Mean change from baseline to 21 ± 2 days in transepidermal water loss (TEWL) to assess skin barrier integrity for Facial Moisturizer B (Control).
timeFrame: 21 ± 2 days
measure: Comparison of transepidermal water loss (TEWL) to assess skin barrier integrity at 21 ± 2 days between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 21 ± 2 days.
measure: Mean change from baseline to 24 hours in transepidermal water loss (TEWL) to assess skin barrier integrity for TH facial moisturizer.
timeFrame: 24 hours
measure: Mean change from baseline to 24 hours in transepidermal water loss (TEWL) to assess skin barrier integrity for Facial Moisturizer B (Control).
timeFrame: 24 hours
measure: Comparison of transepidermal water loss (TEWL) to assess skin barrier integrity at 24 hours between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 24 hours.
measure: Mean change from baseline to 1 hour in transepidermal water loss (TEWL) to assess skin barrier integrity for TH facial moisturizer.
timeFrame: 1 hour
measure: Mean change from baseline to 1 hour in transepidermal water loss (TEWL) to assess skin barrier integrity for Facial Moisturizer B (Control).
timeFrame: 1 hour
measure: Comparison of transepidermal water loss (TEWL) to assess skin barrier integrity at 1 hour between TH facial moisturizer and Facial Moisturizer B (Control)
timeFrame: At 1 hour.
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa Pesquisa Dermato-Cosmetica Ltda
state: Sao Paulo
Study officials:
affiliation: Allergisa Pesquisa Dermato-Cosmetica LTDA
name: Mariane Martins Mosca, Bsc.
role: PRINCIPAL_INVESTIGATOR
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