Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Consumer Inc. (J&JCI)
Conditions:
Skin Regeneration After Dermatological Facial Procedure With Fractional CO2 Laser
Eligibility:
All Genders
18-65 years
Phase:
NA
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 norm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05272787
Start Date
March 10 2022
End Date
June 16 2022
Last Update
June 29 2023
Active Locations (1)
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1
Allergisa Pesquisa Dermato-Cosmetica Ltda
Campinas, São Paulo, Brazil, 13084-791