Clinical Observation of Skin Condition in Patients With Acne Vulgaris Using Ubiquinol, Pomegranate Peel Extract, Ceramide, and Salicylic Acid Emulsion

Официальное название

Clinical Observation of Skin Condition in Patients With Acne Vulgaris Using Ubiquinol, Pomegranate Peel Extract, Ceramide, and Salicylic Acid Emulsion: a 28-day Single-center Prospective Study

Обзор

The goal of this observational study is to evaluate the efficacy and tolerability of a lotion containing panthenol, pomegranate peel extract, ceramides, salicylic acid and Phylobioma (La Roche-Posay Effaclar Duo+M) used in addition to standard care in adult patients with mild-to-moderate acne vulgaris. The main questions it aims to answer are: Does the addition of the lotion improve acne lesion counts and Investigator's Global Assessment (IGA) scores over 28 days? What is the local skin tolerability of the lotion (e.g., erythema, dryness)? No separate comparison group was included; changes are assessed relative to baseline. A total of 40 participants aged 18-40 years with mild-to-moderate acne vulgaris (IGA score ≤3) will be enrolled, excluding those with moderate-to-severe inflammatory skin diseases, known allergy to product ingredients, pregnancy or breastfeeding. Participants will: Provide informed consent and complete baseline evaluations, including acne lesion counting, IGA scoring, and standardized facial photography. Receive the study lotion and apply it daily as part of their skincare routine while continuing their prescribed standard acne treatment. Return at Day 14 and Day 28 for follow-up visits, where they will undergo lesion counting, multispectral artificial intelligence skin analysis, complete the Acne-Specific Quality of Life (ANCE-QOL) questionnaire, rate their satisfaction on a visual analog scale (VAS), report adherence, and have local tolerability assessed (erythema, dryness, etc.).

Подробное описание

This is a single-center, prospective, observational study designed to evaluate the efficacy and tolerability of a lotion containing panthenol, pomegranate peel extract, ceramides, salicylic acid, and Phylobioma (La Roche-Posay Effaclar Duo+M) when used as an adjunct to standard care in outpatients with acne vulgaris over a 28-day period.

A total of 40 participants aged 18 to 40 years with mild-to-moderate acne vulgaris (defined as an Investigator's Global Assessment \[IGA\] score ≤3) will be enrolled. Key exclusion criteria include moderate-to-severe inflammatory skin diseases, known hypersensitivity to any ingredient of the study product, and pregnancy or breastfeeding.

At Day 0 (screening/baseline), eligible participants will provide written informed consent and undergo baseline assessments, including acne lesion counting, IGA scoring, and standardized facial photography. Enrolled participants will then receive the study lotion and be instructed to incorporate it into their daily skincare routine while continuing their prescribed standard acne treatment.

Follow-up visits are scheduled at Day 14 and Day 28. At each visit, the following data will be collected:

* Changes in acne lesion counts; * Multispectral artificial intelligence-based skin diagnostic system measurements; * Acne-Specific Quality of Life (ANCE-QOL) questionnaire responses; * Participant self-rated satisfaction using a visual analog scale (VAS); * Product usage adherence; * Local skin tolerability assessments (including evaluation of erythema, dryness, and other local reactions); * Documentation of concomitant medications. The study lotion is formulated with multi-target ingredients including Phylobioma, salicylic acid, panthenol, pomegranate peel extract, and ceramides. Its intended mechanisms of action include improvement of follicular keratinization, inhibition of \*Cutibacterium acnes\*, reduction of inflammation, and repair of the skin barrier.

The results of this study are expected to provide evidence supporting the use of this dermocosmetic product as an adjuvant treatment for acne vulgaris and to inform strategies for improving patient adherence to acne management regimens.

Первичные конечные точки

• acne lesion counts [Срок оценки: Day28]
• IGA score [Срок оценки: Day28]

Вторичные конечные точки (4)

• Imaging assessment [Срок оценки: Day28]
• Acne-Specific Quality of Life (ANCE-QOL) questionnaire [Срок оценки: Day14,Day28]
• VAS socre [Срок оценки: Day14,Day28]
• Treatment adherence [Срок оценки: Day28]

Критерии участия

Критерии включения

• Aged 18-40 years, any sex.
• Diagnosed with mild-to-moderate acne vulgaris (Investigator's Global Assessment \[IGA\] score ≤3).
• Have skincare needs, are willing to use the study product, and provide signed informed consent.
• Able to comply with follow-up visits and complete the usage feedback form.

Критерии исключения

• Presence of moderate-to-severe inflammatory skin diseases (e.g., rosacea, dermatitis, psoriasis).
• Known history of allergy to any ingredient of the study product.
• Pregnant or breastfeeding women.
• Any condition that, in the investigator's judgment, renders the subject unsuitable for enrollment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07735169 · SYSKY-2025-740-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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