About this trial
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.).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Participants aged 18 to 40 years with mild-to-moderate acne vulgaris (defined as an Investigator's Global Assessment \[IGA\] score ≤3)
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
acne lesion counts
Change in acne lesion counts (inflammatory and non-inflammatory lesions).
IGA score
Investigator's Global Assessment (IGA) acne severity score
Secondary outcomes
Imaging assessment
Multispectral artificial intelligence skin diagnostic system (CBS Cloud Mirror); changes in porphyrin parameters
Acne-Specific Quality of Life (ANCE-QOL) questionnaire
Acne-Specific Quality of Life (ANCE-QOL) questionnaire,The questionnaire is designed to investigate the impacts of acne vulgaris on patients' daily lives, mainly evaluating subjective feelings and quality of life impairment. It contains a total of 19 items. Patients score each item on a scale of 0 to 6, with a maximum total score of 114. Higher total scores indicate less adverse impact of acne on quality of life. The interpretation of total score ranges is as follows: \< 57 points: Severe negative impact of acne on quality of life is likely; 57 - 85 points: Moderate negative impact of acne on quality of life is likely; \> 85 points: Mild or minimal negative impact of acne on quality of life is likely.
VAS socre
Self-rated satisfaction assessed by a Visual Analog Scale (VAS, 0-10),Higher scores indicate higher patient satisfaction.
Treatment adherence
Treatment adherence, recorded as daily frequency of product application
Other outcomes
Safety Outcome Measures
Collection of adverse events, post-treatment adverse reactions, and local skin tolerability assessments, including persistent erythema (\>72 hours), blistering or severe pruritus, worsening of acne, flushing, stinging, dryness, and other local reactions.
Locations
Sponsors and contacts
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