CompletedNot Applicable

A Study to Assess the Effectiveness of Sunscreen on Oil Control, Moisturization, and Skin Barrier Integrity in Adults With Oily Skin

Brazil32 participantsStarted 2024-06-03

Plain-language summary

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.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and/or Women; * 18 to 55 years old; * Phototypes I to VI according to the Fitzpatrick classification; * Subjects of any ethnicity according to Brazilian Institute of Geography and Statistics (IBGE) criteria * Integral skin in the test areas; * Subjects with oily skin, confirmed by instrumental measurements: (sebumetry value of at least 100μg/cm² in the frontal region (average of 3 measurements)). * Subjects with face oil shine - confirmed by Dermatologist; * Subjects with enlarged pores on the face - confirmed by a Dermatologist; * Subjects with self-perceived combination/oily or very oily skin on the face; * Subjects with a self-perceived oil shine on the face; * Subjects with self-perceived enlarged pores on the face; * Do not use cosmetic products (including usual soap) the night before the visit and do not wash your face after 10 p.m. the day before the visit; * For male subjects: who agree to shave 48 hours before the visits; * Generally, in good health based on medical history reported by the subject; * Subjects able to read, write, speak, and understand Portuguese; * Agreeing to adhere to the procedures and requirements of the study and attending the Site on the day(s) and time(s) set for the evaluations; * Subjects who signed the terms Informed Consent Document (ICD) and Informed Consent Image Disclosure (ICID); * Intends to complete the study and is willing and able to follow all the study instructions. Exclusion Criteria: * Has known all…

What they're measuring

Number of Participants With Adverse Events

Timeframe: Up to 28 days

Change From Baseline in Skin Oil Control Assessment During 12-hour Kinetics

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Baseline (Day 1), Day 7 and Day 28 +/- 2 days

Change From Baseline in Skin Barrier Integrity

Timeframe: Baseline (Day 1), Day 7 and Day 28 +/- 2 days

Trial details

NCT IDNCT06616558

SponsorJNTL Consumer Health (Brasil) LTDA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-30

View on ClinicalTrials.gov More Oily Skin trials

Plain-language summary

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Adverse Events

Timeframe: Up to 28 days

Change From Baseline in Skin Oil Control Assessment During 12-hour Kinetics

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Baseline (Day 1), Day 7 and Day 28 +/- 2 days

Change From Baseline in Skin Barrier Integrity

Timeframe: Baseline (Day 1), Day 7 and Day 28 +/- 2 days