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

NCT ID: NCT06616558

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2024-07-30

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.

Conditions

Oily Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sunscreen Home Usage

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.

Group Type: EXPERIMENTAL

Sunscreen SPF 70

Intervention Type: OTHER

Participants will topically apply sunscreen SPF 70

Oil Control Assessment Product Application

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.

Group Type: EXPERIMENTAL

Sunscreen SPF 70

Intervention Type: OTHER

On the randomized side of the half-face, the product will be applied by a qualified technician

Oil control Assessment (Control)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sunscreen SPF 70

Participants will topically apply sunscreen SPF 70

Intervention Type: OTHER

Sunscreen SPF 70

On the randomized side of the half-face, the product will be applied by a qualified technician

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

JNTL Consumer Health (Brasil) LTDA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabrielli Brianezi, PhD

Role: PRINCIPAL_INVESTIGATOR

Johnson & Johnson Consumer Inc. (J&JCI)

Locations

Allergisa Pesquisa Dermato-Cosmética Ltda

Campinas, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CS2024SK100142

Identifier Type: -

Identifier Source: org_study_id