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

ConditionAcne
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-40
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 1 trial group
Group A: Group1

Trial outcomes

Primary outcomes

1

acne lesion counts

Change in acne lesion counts (inflammatory and non-inflammatory lesions).

Time frame
Day28
2

IGA score

Investigator's Global Assessment (IGA) acne severity score

Time frame
Day28

Secondary outcomes

1

Imaging assessment

Multispectral artificial intelligence skin diagnostic system (CBS Cloud Mirror); changes in porphyrin parameters

Time frame
Day28
2

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.

Time frame
Day14,Day28
3

VAS socre

Self-rated satisfaction assessed by a Visual Analog Scale (VAS, 0-10),Higher scores indicate higher patient satisfaction.

Time frame
Day14,Day28
4

Treatment adherence

Treatment adherence, recorded as daily frequency of product application

Time frame
Day28

Other outcomes

1

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.

Time frame
Day28

Locations

This trial has no locations.

Sponsors and contacts

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