AcneNCT07735169
Clinical Observation of Skin Condition in Patients With Acne Vulgaris Using Ubiquinol, Pomegranate Peel Extract, Ceramide, and Salicylic Acid Emulsion
An observational study of Acne, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acne
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants aged 18 to 40 years with mild-to-moderate acne vulgaris (defined as an Investigator's Global Assessment [IGA] score ≤3)
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.).
Read the 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.
- Conditions
- Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
acne lesion counts
Change in acne lesion counts (inflammatory and non-inflammatory lesions).
Measured: Day28
IGA score
Investigator's Global Assessment (IGA) acne severity score
Measured: Day28
Secondary outcomes (4)
Imaging assessment
Multispectral artificial intelligence skin diagnostic system (CBS Cloud Mirror); changes in porphyrin parameters
Measured: Day28
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.
Measured: Day14,Day28
VAS socre
Self-rated satisfaction assessed by a Visual Analog Scale (VAS, 0-10),Higher scores indicate higher patient satisfaction.
Measured: Day14,Day28
Treatment adherence
Treatment adherence, recorded as daily frequency of product application
Measured: Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Sha, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Sha Lu, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735169
- Sponsor's protocol ID
- SYSKY-2025-740-02
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07735169
- Acronym / sponsor ID
- SYSKY-2025-740-02
- Conditions
- Acne
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | –Experimental group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants aged 18 to 40 years with mild-to-moderate acne vulgaris (defined as an Investigator's Global Assessment [IGA] score ≤3)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
acne lesion counts
Time frame: Day28
Change in acne lesion counts (inflammatory and non-inflammatory lesions).
IGA score
Time frame: Day28
Investigator's Global Assessment (IGA) acne severity score
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sha Lu principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Acne, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Tang (8615876989020, tangy285@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acne lesion counts (time frame: Day28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.