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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Sunscreen C Color 2.0 Sun Protection Factor (SPF) 70 and Sunscreen M Very Light SPF 50 | Experimental | 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. |
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| Arm 2: Sunscreen C Color 2.0 SPF 70 and Sunscreen M Golden Color SPF 50 | Experimental | 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. |
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| Arm 3: Sunscreen C Color 3.0 SPF 70 and Sunscreen M Very Light SPF 50 | Experimental | 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. |
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| Arm 4: Sunscreen C Color 3.0 SPF 70 and Sunscreen M Golden Color SPF 50 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunscreen C Color 2.0 SPF 70 | Other | Sunscreen C color 2.0 SPF 70 will be applied topically on half of the face. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Dermatological Tolerability | Change from baseline in dermatological tolerability will be reported. Dermatological tolerability includes a clinical assessment of the participant's initial skin condition, carried out by the study dermatologist according to the Skin Reaction Intensity Assessment Scale. Skin reaction intensity assessment of erythema, edema, blistering and peeling on the face will be done. Each skin reaction was scored on 4-point scale 0 = absent, 1 = mild, 2 =moderate, and 3 = intense. A decrease in score at post-baseline timepoints compared to baseline indicates an improvement. | Baseline (Day 1), Day 21 |
| Change From Baseline in Skin Barrier Integrity | Change from baseline in skin barrier integrity will be reported. The facial skin barrier will be assessed by a trained technician using instrumental measurements with the Tewameter TM 300. The Tewameter measures transepidermal water loss (TEWL) that is the flow of water out of the skin. TEWL measurement will be taken in the nasolabial region of each half of the face. | Baseline (Day 1), Day 21 |
| Number of Participants With Sensory Perception as Assessed by Sensory Perception Questionnaire | Number of participants with sensory perception as assessed by sensory perception questionnaire will be reported. The sensory perception of each sunscreen will be concluded from the data obtained from the sensory perception questionnaire which includes overall satisfaction, skin and eye irritation, comfort and other characteristics (stickiness, lightness etcetera). Sensory perception questionnaire includes 1 question on overall satisfaction with sunscreen by scoring on a scale ranged from 1 to 7, 1= disliked very much and 7= liked very much; 3 questions with participant's response on "does not irritate the skin, eye and felt comfortable using the sunscreen" on a response scale ranging from 1 to 5, 1= strongly disagree and 5= strongly agree; and 1 question that correlate the characteristic (stickiness, lightness etcetera.) with each product tested. | At Day 21 |
| Number of Participants With Skin Sensitivity as Assessed by Discomfort Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabrielli Brianezi | Johnson & Johnson Consumer Inc. (J&JCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergisa Pesquisa Dermato-Cosmetica Ltda | Campinas | São Paulo | 13084-791 | Brazil |
Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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| Sunscreen C Color 3.0 SPF 70 | Other | Sunscreen C color 3.0 SPF 70 will be applied topically on half of the face. |
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| Sunscreen M Very Light SPF 50 | Other | Sunscreen M very light SPF 50 will be applied topically on half of the face. |
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| Sunscreen M Golden Color SPF 50 | Other | Sunscreen M golden color SPF 50 will be applied topically on half of the face. |
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Number of participants with skin sensitivity as assessed by perception questionnaire on discomfort signs will be reported. Assessment of skin sensitivity after application of each sunscreen will be concluded from the data obtained by filling in the questionnaire on the perception of signs of discomfort. Perception questionnaire on discomfort signs includes sensation of discomfort, burning sensation, itching, redness sensation on skin and eye irritation. For each sign the participant will select a response on a scale ranging from 0 to 9, where 0 = no discomfort sign and 9= intense discomfort sign. Higher score indicates intense discomfort sign. If a participant has a moderate or/to intense reaction (from 4 to 9) an adverse event will be open. |
| At Day 1 |
| Number of Participants With Adverse Events | Number of participants with adverse events will be reported. An adverse event is any untoward medical occurrence in a clinical study participant temporally associated with the clinical investigation, whether or not the event has a causal relationship to the participants' participation in the trial. It is therefore any unfavorable and unintended sign (including an abnormal finding), symptom, or disease that occurs during the trial. This can include any occurrence that is new in onset, an aggravation of severity/frequency of a baseline condition, or abnormal results of diagnostic procedures, including laboratory test abnormalities. | Up to Day 21 |