Clinical trial NCT06544889: A Study to Assess the Safety and Efficacy of a Sunscreen on Acne-Prone Skin With Inflammatory and Non-Inflammatory Acne Vulgaris
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).


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:

  1. At least 1 PIE
  2. At least PIH
* For male subjects: who agree to shave 24 hours before Visits 1, 2, and 3;
* Subjects able to read, write, speak, and understand Portuguese;
* Subjects who signed the terms ICD - Informed Consent Document and ICID - Informed Consent Image Disclosure;
* Intends to complete the study and is willing and able to follow all study instructions and attend the Site on the day(s) and at the time(s) set for the evaluations;

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;
* Using any medication to treat diseases of the face or eyes;
* Use of any other products capable of interfering with the study evaluations, at the discretion of the dermatologist;
* Subjects who have hormonal dysfunction that may influence the study results, at the discretion of the attending physician (for example, subjects with a history of irregular menstruation, polycystic ovary syndrome, users of anabolic steroids, and/or medication for hormone treatment, etc);
* Moderate to severe acne skin, confirmed by a dermatologist;
* Has a history of or a concurrent health condition/situation that may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study;
* Has washed their face less than 2 hours before the study assessments;
* Excessive hair in the assessment area that could interfere with visual measurements. In the case of men, even in the presence of excessive hair in the beard area, they will be instructed to shave 24 hours before the visit;
* Simultaneously taking part in another study;
* Being an employee/contractor or close relative of the PI, Study Site, or Sponsor.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 28 days
measure: Topical tolerability as assessed by the dermatologist
timeFrame: Baseline, Day 7 and Day 28 +/- 2 days
measure: Number of Participants with Improvement from Baseline in Acne and Comedones
timeFrame: Baseline, Day 7 and Day 28 +/- 2 days
measure: Change from Baseline in Clinical Effectiveness Assessment on Post-Inflammatory Hyperpigmentation
timeFrame: Baseline, Day 7 and Day 28 +/- 2 days
measure: Change from Baseline in Clinical Effectiveness Assessment on Post-Inflammatory Erythema
timeFrame: Baseline, Day 7 and Day 28 +/- 2 days
measure: Number of Participants with Improvement From Baseline in Acne Mark Attributes Assessed Using the Visia-CR Facial Imaging Booth
timeFrame: Baseline, 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 +/- 2 days
measure: Testimonial Regarding the Experience with Sunscreen
timeFrame: End of the study (Day 28 +/- 2 days)
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: