Clinical trial NCT06243627: A Study to Assess Safety and Improvement in Skin Barrier After Using 2 Facial Sunscreens in Adults With Sensitive Skin
Official title: A Single-Center, Comparative, Randomized, Safety-in-Use Clinical Study to Assess Skin Acceptability and Efficacy in Improving Skin Barrier Function of Two Facial Sunscreens in Adult Participants With Sensitive Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2024-02-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this trial is to evaluate 1) the dermatological tolerability of 2 facial sunscreens after 21 (+2) days of use under normal conditions on the half face by adult subjects with sensitive skin, 2) Compare the efficacy of investigational products (IPs) after 21 (+2) days of use in adult subjects with sensitive skin, under dermatological supervision through the following evaluations: the transepidermal water loss in the nasolabial region; the sensory perception of the subjects using the sensory perception questionnaire, after 21 (+2) days of use under normal conditions; the sensitivity of the subjects' skin after the first application of each product using a questionnaire on the perception of signs of discomfort.


Eligibility criteria: Inclusion Criteria:

* Participants vaccinated against coronavirus disease 2019 (COVID-19)
* 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 have had allergies or adverse reactions to common topical skincare products, including sunscreens, medications, or other products that the investigator considers relevant
* 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

Primary outcomes:
measure: Change From Baseline in Dermatological Tolerability
timeFrame: Baseline (Day 1), Day 21
measure: Change From Baseline in Skin Barrier Integrity
timeFrame: Baseline (Day 1), Day 21
measure: Number of Participants With Sensory Perception as Assessed by Sensory Perception Questionnaire
timeFrame: At Day 21
measure: Number of Participants With Skin Sensitivity as Assessed by Discomfort Questionnaire
timeFrame: At Day 1
measure: Number of Participants With Adverse Events
timeFrame: Up to Day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa Pesquisa Dermato-Cosmetica Ltda
state: Sao Paulo
Study officials:
affiliation: Johnson & Johnson Consumer Inc. (J&JCI)
name: Gabrielli Brianezi
role: PRINCIPAL_INVESTIGATOR
References: