A Study to Assess the Safety and Efficacy of a Sunscreen on Acne-Prone Skin With Inflammatory and Non-Inflammatory Acne Vulgaris
NCT Number: NCT06544889
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acne Vulgaris
Interventions: OTHER: Sunscreen SPF 70
Sponsor: JNTL Consumer Health (Brasil) LTDA
Sex: ALL
Age: ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-05-09
Completion Date: 2024-06-18
Locations: Allergisa Pesquisa Dermato-Cosmética Ltda, Campinas, São Paulo, 13084-791, Brazil

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).

Primary Outcome Measures: Number of participants with adverse events, Number of participants with adverse events will be reported. An adverse event is any untoward medical occurrence in a clinical study participant temporally associated with the clinical investigation, whether or not the event has a causal relationship to the participants' participation in the trial. It is therefore any unfavorable and unintended sign (including an abnormal finding), symptom, or disease that occurs during the trial. This can include any occurrence that is new in onset, an aggravation of severity/frequency of a baseline condition, or abnormal results of diagnostic procedures, including laboratory test abnormalities., Up to 28 days|Topical tolerability as assessed by the dermatologist, Topical tolerability will be assessed using skin reaction intensity evaluation scale. Skin Reaction Intensity Evaluation Scale is a composite evaluation of any irritation/reaction subscoring for erythema, peeling, vesiculation, and edema. The scale ranges from 0=absent to 4=intense., Baseline, Day 7 and Day 28 +/- 2 days|Number of Participants with Improvement from Baseline in Acne and Comedones, The comedogenic and acnegenic potential will be evaluated by comparing the final acne lesion counts (D28) with the baseline acne lesion counts. The lesions will be classified as closed comedones (whiteheads), open comedones (blackheads), pustules (pustules) and papules (papules). The lesions will be counted in 05 areas of the face: 02 in the frontal region, 02 in the malar region and chin, papules and pustules will be counted on the entire face (except the nose)., Baseline, Day 7 and Day 28 +/- 2 days|Change from Baseline in Clinical Effectiveness Assessment on Post-Inflammatory Hyperpigmentation, Change from Baseline in Clinical Effectiveness Assessment on Post-Inflammatory Hyperpigmentation (PIH) will be reported. A 10-point ordinal scale (0 to 9) will be used. Therefore, as it is an ordinal scale, the intermediate points do not have an established definition. For PIH, the evaluated area will be the Global Face and the scale to be used is defined from 0 = None, uniform skin color with no observable hyperpigmentation to 9 = Severe/highly visible, deep color difference., Baseline, Day 7 and Day 28 +/- 2 days|Change from Baseline in Clinical Effectiveness Assessment on Post-Inflammatory Erythema, Change from Baseline in Clinical Effectiveness Assessment on Post-Inflammatory Erythema (PIE) will be reported. A 10-point ordinal scale (0 to 9) will be used. Therefore, as it is an ordinal scale, the intermediate points do not have an established definition. For PIE, the evaluated area will be the Global Face and the scale to be used is defined from 0 = None, skin color without observable erythema to 9 = Severe/Highly visible, color difference between skin and spot intense., Baseline, Day 7 and Day 28 +/- 2 days|Number of Participants with Improvement From Baseline in Acne Mark Attributes Assessed Using the Visia-CR Facial Imaging Booth, Facial images will be captured using the Visia CR Facial Imaging Booth. Three Three images per participant will be captured: right lateral, left lateral and frontal using using the Cross Polarized, Standard 2 and RBX (Red) filters. The captured images will be further analyzed using specific image analysis software to evaluate the reduction in acne, improvement in PIE and PIH, reduction in acne marks., Baseline, Day 7 and Day 28 +/- 2 days|Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen on Day 7, Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen on Day 7 will be reported. Participants will answer 11 questions and rate as: totally disagree, disagree, neither agree nor disagree, agree and totally agree., Day 7|Participant's Self-perceived Questionnaire to Assess the Clinical Effectiveness of the Sunscreen on Day 28, Participant's self-perceived questionnaire to assess the clinical effectiveness of the sunscreen on Day 28 will be reported. Participants will answer 11 questions and rate as: totally disagree, disagree, neither agree nor disagree, agree and totally agree., Day 28 +/- 2 days|Testimonial Regarding the Experience with Sunscreen, A testimonial regarding the experience with sunscreen will be provided by the participants through an open question at the end of the study. The purpose is to know their opinion and experience using this product during the study., End of the study (Day 28 +/- 2 days)