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The purpose of this trial is to evaluate 1) the efficacy of an investigational product (sunscreen) when compared to a control area (without product application) in controlling oiliness, oil shine and the effect on pores appearance in a 12-hour kinetics through a) Instrumental measurements, b) Expert Grader and c) Perceived efficacy; 2) the efficacy of an investigational product in reducing oiliness, improving hydration, the pores appearance and the integrity of the skin barrier, after 7 days of use and after 28 ± 2 days of use through instrumental measurements and perceived efficacy questionnaires.
The objectives of this study are:
To evaluate the efficacy of an investigational product (sunscreen) when compared to a control area (without product application) in controlling oiliness, oil shine and the effect on pores appearance in a 12-hour kinetics:
To evaluate the efficacy of an investigational product in reducing oiliness, improving hydration, pores appearance and the integrity of the skin barrier, after 7 days of use and after 28 ± 2 days of use, under normal conditions of use in adult participants through the following evaluations:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunscreen Home Usage | Experimental | Participants will use the Sunscreen in normal conditions at home for 28 +/- 2 days, returning to the Site after 7 days of product use, then make the last study visit to complete the final analysis. |
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| Oil Control Assessment Product Application | Experimental | An amount of Investigational Product will be topically applied to malar and forehead areas (after cleansing the face) on one randomized side of the participant's face by a qualified technician to perform the assessment of a 12-hour kinetics. After the evaluations the product will be removed. |
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| Oil control Assessment (Control) | No Intervention | On the randomized half-side (malar and forehead areas), no product will be applied and this will be the control for evaluating the product's oil control during the 12-hour kinetics. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunscreen SPF 70 | Other | Participants will topically apply sunscreen SPF 70 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 28 days |
| Change From Baseline in Skin Oil Control Assessment During 12-hour Kinetics | Change from baseline in skin oil control will be reported. The facial oil control will be assessed by a trained technician using instrumental measurements with the Sebumeter SM 815. The Sebumeter measures amount of sebum per area. Sebumetric measurements will be taken in the forehead region of each half of the face during a 12-hour kinetics. One half of the forehead region will contain the Investigational Product and the other half will be the control, with no product applied. | Day 1: Baseline, 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours |
| Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen During 12-hour Kinetics | Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen on oil and shine control. Participants will answer 6 questions and rate as: totally disagree, disagree, neither agree nor disagree, agree and totally agree. The area to be evaluated is half face with and without product applied. | Day 1: Baseline, 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours |
| Change From Baseline in Clinical Effectiveness on Oil Shine | Change from Baseline in Clinical Effectiveness Assessment on Oil Shine will be reported. A 10-point ordinal scale (0 to 9) will be used. Therefore, as it is an ordinal scale, the intermediate points do not have an established definition. The evaluated area will be each half face and the scale to be used is defined from 0 = Dull, matte skin to 9 = Very intense oil shine, very oily skin. The time-points will me compared in terms of statistical improvement (improvement of oiliness shine (regulation)) versus the baseline. |
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Inclusion Criteria:
Exclusion Criteria:
Has known allergies or adverse reactions to common topical skin care products including sunscreens;
Presents a skin condition that may confound the study results (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer);
Have primary/secondary lesions (e.g. scars, ulcers, vesicles) or tattoos in the test areas;
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:
Use of any other products capable of interfering with the study evaluations, at the discretion of the dermatologist;
Subjects who have undergone invasive aesthetic or dermatological treatment in the test area within 2 months prior to the start of the study or during the study;
Subjects who had used cosmetic products to treat oiliness/shine on the same area (face) within 14 days prior to the start of the study;
Subjects who are using any medication to treat diseases of the face or eyes;
Subjects who reported being pregnant, or planning to become pregnant during the study;
Has a history of or a concurrent health 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;
Simultaneously taking part in another study;
Being an employee/contractor or close relative of the Principal Investigator, Study Site, or Sponsor;
Excessive hair in the assessment area that could interfere with instrumental measurements.
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| Name | Affiliation | Role |
|---|---|---|
| Gabrielli Brianezi, PhD | Johnson & Johnson Consumer Inc. (J&JCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergisa Pesquisa Dermato-Cosmética Ltda | Campinas | São Paulo | 13084-791 | Brazil |
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| Sunscreen SPF 70 |
| Other |
On the randomized side of the half-face, the product will be applied by a qualified technician |
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| Day 1: Baseline, 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours |
| Change From Baseline in Clinical Effectiveness on Pores Appearance | Change from Baseline in Clinical Effectiveness Assessment on Pores Appearance will be reported. A 10-point ordinal scale (0 to 9) will be used. Therefore, as it is an ordinal scale, the intermediate points do not have an established definition. The evaluated area will be each half face and the scale to be used is defined from 0 =small, hardly visible to 9 = large, easily visible. The time-points will me compared in terms of statistical improvement (improvement in the appearance (number and/or size) of pores) versus the baseline. | Day 1: Baseline, 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours and 12 hours |
| Change From Baseline in Skin Oil Control Assessment | Change from baseline in skin oil control will be reported. The facial oil control will be assessed by a trained technician using instrumental measurements with the Sebumeter SM 815. The Sebumeter measures amount of sebum per area. Sebumetric measurements will be taken in the forehead region. | Baseline (Day 1), Day 7 and Day 28 +/- 2 days |
| 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 one randomized half of the face. | Baseline (Day 1), Day 7 and Day 28 +/- 2 days |
| Change From Baseline in Skin Hydration | Change from baseline in skin hydration will be reported. The facial skin hydration will be assessed by a trained technician using instrumental measurements with the Corneometer® CM825. The Corneometer measures the dielectric constant of the skin. The dielectric constant of skin will change with water content of the stratum Corneum, that can be converted into arbitrary units of hydration. Corneometer measurement will be taken in the malar region of one randomized half of the face. | Baseline (Day 1), Day 7 and Day 28 +/- 2 days |
| Number of Participants with Improvement From Baseline in Skin Appearance Assessed Using the Visia-CR Facial Imaging Booth | Facial images will be captured using the Visia CR Facial Imaging Booth. Three Three images per participant will be captured: right lateral, left lateral and frontal. The captured images will be further analyzed using specific image analysis software to evaluate improvement in the attributes of oiliness reduction, shine reduction, pore size reduction, and pore clearance, versus baseline and also between time-points. | Baseline (Day 1), Day 7 and Day 28 +/- 2 days |
| Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen on Day 7 | Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen on Day 7 will be reported. Participants will answer 1 question on overall satisfaction with sunscreen by scoring as: disliked a lot, disliked, neither liked nor disliked, liked and liked a lot. Additionally, 15 attributes will be presented to be rated as: totally disagree, disagree, neither agree nor disagree, agree and totally agree. | Day 7 |
| Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen on Day 28 | Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen on Day 28 will be reported. Participants will answer 1 question on overall satisfaction with sunscreen by scoring as: disliked a lot, disliked, neither liked nor disliked, liked and liked a lot. Additionally, 15 attributes will be presented to be rated as: totally disagree, disagree, neither agree nor disagree, agree and totally agree. | Day 28 |