A Study to Assess Safety and Improvement in Skin Barrier After Using 2 Facial Sunscreens in Adults With Sensitive Skin
Status
Completed
Conditions
Healthy
Treatments
Other: Sunscreen M Golden Color SPF 50
Other: Sunscreen C Color 2.0 SPF 70
Other: Sunscreen C Color 3.0 SPF 70
Other: Sunscreen M Very Light SPF 50
Details and patient eligibility
About
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.
Enrollment
35 patients
Sex
All
Ages
18+ years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
35 participants in 4 patient groups
Arm 1: Sunscreen C Color 2.0 Sun Protection Factor (SPF) 70 and Sunscreen M Very Light SPF 50
Experimental group
Description:
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.
Treatment:
Other: Sunscreen M Very Light SPF 50
Other: Sunscreen C Color 2.0 SPF 70
Arm 2: Sunscreen C Color 2.0 SPF 70 and Sunscreen M Golden Color SPF 50
Experimental group
Description:
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.
Treatment:
Other: Sunscreen C Color 2.0 SPF 70
Other: Sunscreen M Golden Color SPF 50
Arm 3: Sunscreen C Color 3.0 SPF 70 and Sunscreen M Very Light SPF 50
Experimental group
Description:
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.
Treatment:
Other: Sunscreen M Very Light SPF 50
Other: Sunscreen C Color 3.0 SPF 70
Arm 4: Sunscreen C Color 3.0 SPF 70 and Sunscreen M Golden Color SPF 50
Experimental group
Description:
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.
Treatment:
Other: Sunscreen C Color 3.0 SPF 70
Other: Sunscreen M Golden Color SPF 50
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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