Clinical Observation of Skin Condition in Patients With Acne Vulgaris Using Ubiquinol, Pomegranate Peel Extract, Ceramide, and Salicylic Acid Emulsion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acne. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.).
Detailed description
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.
Primary outcome measures
- acne lesion counts [Time frame: Day28]
- IGA score [Time frame: Day28]
Secondary outcome measures (4)
- Imaging assessment [Time frame: Day28]
- Acne-Specific Quality of Life (ANCE-QOL) questionnaire [Time frame: Day14,Day28]
- VAS socre [Time frame: Day14,Day28]
- Treatment adherence [Time frame: Day28]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07735169 · SYSKY-2025-740-02