Clinical trial NCT06616558: A Study to Assess the Effectiveness of Sunscreen on Oil Control, Moisturization, and Skin Barrier Integrity in Adults With Oily Skin
Official title: A Single-Center, Open-Label, Randomized Clinical Study to Evaluate the Oil Control Efficacy, Moisture Assessment and Skin Barrier Integrity of an Investigational Product in Adult Participants With Oily Facial Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oily Skin
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2024-09-27
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: 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 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.

Detailed description: 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:

* Instrumental measurements with the Sebumeter® SM 815 equipment to assess oiliness control;
* Clinical efficacy evaluation carried out by Expert Grader
* Perceived efficacy through perception questionnaires

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:

* Instrumental measurements with the Sebumeter® SM 815 equipment before and after 7 and 28 ± 2 days of use on the face to assess oil reduction;
* Instrumental measurements with the Corneometer® before and after 7 and 28 ± 2 days of use on the face to assess skin hydration;
* Instrumental measurements with the Tewameter® TM 300 before and after 7 and 28 ± 2 days of use on the face to assess the integrity/maintenance of the skin barrier;
* Facial images captured using Visia® CR equipment before and after 7 and 28 ± 2 days of use on the face;
* Perceived efficacy through perception questionnaires answered by research participants after 7 and 28 ± 2 days of use on the face;
* Open-ended emotional statement after 28 ± 2 days.

Eligibility criteria: 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 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:

  * Immunosuppressive or steroidal drugs within 2 months before Visit 1\*
  * Non-steroidal anti-inflammatory drugs within 5 days before Visit 1\* (For Oxaprozin and Piroxicam consider 2 weeks 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".
* 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.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to 28 days
measure: 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
measure: 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
measure: 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
measure: 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
measure: Change From Baseline in Skin Oil Control Assessment
timeFrame: Baseline (Day 1), Day 7 and Day 28 +/- 2 days
measure: Change From Baseline in Skin Barrier Integrity
timeFrame: Baseline (Day 1), Day 7 and Day 28 +/- 2 days
measure: Change From Baseline in Skin Hydration
timeFrame: Baseline (Day 1), Day 7 and Day 28 +/- 2 days
measure: Number of Participants with Improvement From Baseline in Skin Appearance Assessed Using the Visia-CR Facial Imaging Booth
timeFrame: Baseline (Day 1), Day 7 and Day 28 +/- 2 days
measure: Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen on Day 7
timeFrame: Day 7
measure: Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen on Day 28
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa Pesquisa Dermato-Cosmética Ltda
state: São Paulo
Study officials:
affiliation: Johnson & Johnson Consumer Inc. (J&JCI)
name: Gabrielli Brianezi, PhD
role: PRINCIPAL_INVESTIGATOR
References: