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

JNTL Consumer Health (Brasil) LTDA

Status: Completed

Conditions: Oily Skin

Treatments: Other: Sunscreen SPF 70

Study type: Interventional

Funder types: Industry

Identifiers

NCT06616558

CS2024SK100142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

Sunscreen Home Usage

Experimental group

Description:

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.

Treatment:

Other: Sunscreen SPF 70

Other: Sunscreen SPF 70

Oil Control Assessment Product Application

Experimental group

Description:

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.

Treatment:

Other: Sunscreen SPF 70

Other: Sunscreen SPF 70

Oil control Assessment (Control)

No Intervention group

Description:

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.