A Study to Assess Safety and Improvement in Skin Barrier After Using 2 Facial Sunscreens in Adults With Sensitive Skin
NCT ID: NCT06243627
Last Updated: 2024-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2023-09-27
2023-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Arm 1: Sunscreen C Color 2.0 Sun Protection Factor (SPF) 70 and Sunscreen M Very Light SPF 50
The participants will apply topically two colored sunscreens: C color 2.0 and M very light, one on each half of the face at least twice a day for 21 days.
Sunscreen C Color 2.0 SPF 70
Sunscreen C color 2.0 SPF 70 will be applied topically on half of the face.
Sunscreen M Very Light SPF 50
Sunscreen M very light SPF 50 will be applied topically on half of the face.
Arm 2: Sunscreen C Color 2.0 SPF 70 and Sunscreen M Golden Color SPF 50
The participants will apply topically two colored sunscreens: C color 2.0 and M golden color, one on each half of the face at least twice a day for 21 days.
Sunscreen C Color 2.0 SPF 70
Sunscreen C color 2.0 SPF 70 will be applied topically on half of the face.
Sunscreen M Golden Color SPF 50
Sunscreen M golden color SPF 50 will be applied topically on half of the face.
Arm 3: Sunscreen C Color 3.0 SPF 70 and Sunscreen M Very Light SPF 50
The participants will apply topically two colored sunscreens: C color 3.0 and M very light, one on each half of the face at least twice a day for 21 days.
Sunscreen C Color 3.0 SPF 70
Sunscreen C color 3.0 SPF 70 will be applied topically on half of the face.
Sunscreen M Very Light SPF 50
Sunscreen M very light SPF 50 will be applied topically on half of the face.
Arm 4: Sunscreen C Color 3.0 SPF 70 and Sunscreen M Golden Color SPF 50
The participants will apply topically two colored sunscreens: C color 3.0 and M golden color, one on each half of the face at least twice a day for 21 days.
Sunscreen C Color 3.0 SPF 70
Sunscreen C color 3.0 SPF 70 will be applied topically on half of the face.
Sunscreen M Golden Color SPF 50
Sunscreen M golden color SPF 50 will be applied topically on half of the face.
Interventions
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Sunscreen C Color 2.0 SPF 70
Sunscreen C color 2.0 SPF 70 will be applied topically on half of the face.
Sunscreen C Color 3.0 SPF 70
Sunscreen C color 3.0 SPF 70 will be applied topically on half of the face.
Sunscreen M Very Light SPF 50
Sunscreen M very light SPF 50 will be applied topically on half of the face.
Sunscreen M Golden Color SPF 50
Sunscreen M golden color SPF 50 will be applied topically on half of the face.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants of any gender
* Participants of any ethnicities according to Brazilian Institute of Geography and Statistics (IBGE) criteria
* Phototype II to IV according to Fitzpatrick's classification
* Participants - in good health based on medical history reported by the subject
* Participants presenting intact skin on the face, with the exception of clinical signs characteristic of sensitive skin
* Participants who declare themselves as having sensitive skin (according to the Institute's sensitive skin questionnaire, completed in the recruitment phase and reconfirmed by the physician on the day of inclusion)
* Able to read, write, speak and understand Portuguese (able to read and understand the documents delivered and what is explained to them)
* Participants who agree to maintain their cosmetic habits during the study period
* Participants who agree to maintain their cosmetic habits during the study period
* Participant who signed the Informed Consent Document (ICD)
* Agreement to adhere to the procedures and requirements of the study and to attend the Site on the day(s) and time(s) determined for the assessments
* Participant that intend to complete the study and is willing and able to follow all study instructions
Exclusion Criteria
* Participants that present a skin condition that may influence the study results (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, intense erythema, or active skin cancer). Mild erythema and xerosis associated with a sensitive skin condition are acceptable for eligibility
* Participants that present primary/secondary lesions (for example: scars, ulcers, vesicles, vitiligo) or tattoos on the test areas
* Participants that have undertaken cosmetic or dermatological treatment, invasive or non-invasive, in the test areas within 3 weeks before the beginning of the study and during the study
* Participants that have self-reported Type 1 or Type 2 diabetes or are taking insulin or another anti-diabetic medication
* Participants that are taking a medication that would mask an adverse event (AE) or influence 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"
* Participants that are self-reported to be pregnant or planning to become pregnant during the study
* Participants that have a history of a health condition/situation which may put the individual at significant risk, influence the study results, or interfere significantly with the individual's participation in the study
* Participants that are simultaneously participating in any other study
* Participants that are employees/contractors or immediate family members of the principal investigator (PI), study site, or sponsor
* History of non-adherence or unwillingness to adhere to the study protocol
* Any condition not previously mentioned that, in the opinion of the PI, may compromise the study evaluation
18 Years
ALL
Yes
Sponsors
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Johnson & Johnson Consumer Inc. (J&JCI)
INDUSTRY
Responsible Party
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Principal Investigators
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Gabrielli Brianezi
Role: PRINCIPAL_INVESTIGATOR
Johnson & Johnson Consumer Inc. (J&JCI)
Locations
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Allergisa Pesquisa Dermato-Cosmetica Ltda
Campinas, São Paulo, Brazil
Countries
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Other Identifiers
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CCSSKA005438
Identifier Type: -
Identifier Source: org_study_id
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