A Single Center, Open-Label, Non-Randomized, Safety in Use Clinical Study to Assess The Topical Tolerability, Comedogenic and Acnegenic Potential, and Efficacy in Inflammatory and Non-Inflammatory Acne Vulgaris of a Sunscreen in Adult Subjects With Oily and Combination, Acne-Prone Skin

JNTL Consumer Health (Brasil) LTDA1 site in 1 country32 target enrollmentMay 9, 2024

ConditionsAcne Vulgaris

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acne Vulgaris
Sponsor: JNTL Consumer Health (Brasil) LTDA
Enrollment: 32
Locations: 1
Primary Endpoint: Topical tolerability as assessed by the dermatologist
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this trial is to evaluate 1) To assess the dermatological tolerability and the absence of acnegenic and comedogenic potential of 1 facial sunscreen, after 28 ± 2 days of use under normal conditions by adult subjects with acne prone skin, 2) To assess the clinical efficacy of the topical product in inflammatory and non-inflammatory acne vulgaris, and in the reduction of post-inflammatory erythema (PIE) and post-inflammatory hyperpigmentation (PIH) spots, under normal conditions of use; 3) Facial image capture with the VISIA-CR® Analysis System (Canfield Scientific, Inc.) equipment, to analyze acne marks and record before and after; 4)Assessment of perception by the study subject through Self-Perceived Effectiveness questionnaires and satisfaction surveys (emotional testimony).

Registry

clinicaltrials.gov

Start Date

May 9, 2024

End Date

June 18, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

JNTL Consumer Health (Brasil) LTDA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men and/or Women;
•18 to 55 years old;
•Subjects vaccinated against COVID-19;
•Subjects of all ethnicities according to IBGE criteria - IBGE-The Brazilian Institute of Geography and Statistics;
•Phototypes I to IV according to the Fitzpatrick classification;
•Oily or combination skin with a tendency to acne - confirmed by a dermatologist;
•Healthy skin in the test area (except for comedones and occasional inflammatory lesions - papules and pustules);
•Generally, in good health based on medical history reported by the subject;
•Subjects with mild elementary acne lesions (Grade 2 on the IGA scale), including non-inflammatory and/or inflammatory lesions (papules/pustules only, no nodular lesions) - proven by a dermatologist;
•Subjects presenting the following criteria on the face, confirmed by Expert Grader:

Exclusion Criteria

•Has known allergies or adverse reactions to common topical skin care products including sunscreens; medications, or other products that the investigator deems relevant;
•Presents a skin condition that may confound the study results (specifically psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer);
•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.
•Is currently using or has used any facial products containing acne active ingredients (e.g. benzoyl peroxide, salicylic acid, etc.) within the past 2 weeks or longer, if in the opinion of the Study Physician this could interfere with study results;
•Aesthetic or dermatologic treatment, invasive or non-invasive, in the test areas within 2 weeks prior to the start of the study and during the study;
•Subjects who reported being pregnant, or planning to become pregnant during the study;