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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07735169
Enrollment
40
Registered
2026-07-29
Start date
2026-07-20
Completion date
2026-12-31
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne

Brief summary

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.

Interventions

None listed

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

1. Aged 18-40 years, any sex. 2. Diagnosed with mild-to-moderate acne vulgaris (Investigator's Global Assessment \[IGA\] score ≤3). 3. Have skincare needs, are willing to use the study product, and provide signed informed consent. 4. Able to comply with follow-up visits and complete the usage feedback form.

Exclusion criteria

1. Presence of moderate-to-severe inflammatory skin diseases (e.g., rosacea, dermatitis, psoriasis). 2. Known history of allergy to any ingredient of the study product. 3. Pregnant or breastfeeding women. 4. Any condition that, in the investigator's judgment, renders the subject unsuitable for enrollment

Design outcomes

Primary

MeasureTime frameDescription
acne lesion countsDay28Change in acne lesion counts (inflammatory and non-inflammatory lesions).
IGA scoreDay28Investigator's Global Assessment (IGA) acne severity score

Secondary

MeasureTime frameDescription
Imaging assessmentDay28Multispectral artificial intelligence skin diagnostic system (CBS Cloud Mirror); changes in porphyrin parameters
Acne-Specific Quality of Life (ANCE-QOL) questionnaireDay14,Day28Acne-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 socreDay14,Day28Self-rated satisfaction assessed by a Visual Analog Scale (VAS, 0-10),Higher scores indicate higher patient satisfaction.
Treatment adherenceDay28Treatment adherence, recorded as daily frequency of product application

Contacts

CONTACTYing Tang
tangy285@mail.sysu.edu.cn8615876989020
PRINCIPAL_INVESTIGATORSha Lu

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026