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

NCT07735169 | Not Yet Recruiting

• 1 other identifier: SYSKY-2025-740-02
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.).

Conditions

Acne

Outcome Measures

Primary Outcomes (2)

• acne lesion counts

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

  Day28

• IGA score

  Investigator's Global Assessment (IGA) acne severity score

  Day28

Secondary Outcomes (4)

• Imaging assessment

  Day28

• Acne-Specific Quality of Life (ANCE-QOL) questionnaire

  Day14,Day28

• VAS socre

  Day14,Day28

• Treatment adherence

  Day28

Other Outcomes (1)

• Safety Outcome Measures

  Day28

Study Arms (1)

Group1

Experimental group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants aged 18 to 40 years with mild-to-moderate acne vulgaris (defined as an Investigator's Global Assessment \[IGA\] score ≤3)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Sha Lu

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Tang

CONTACT

8615876989020; tangy285@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 29, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR