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Efficacy and Safety of Azelaic Acid and Azelaic Acid Combined with Compound Acid in the Treatment of Post-Inflammatory Erythema and Pigmentation of Acne: A Single-center, Prospective, Randomized Controlled Clinical Study Protocol

Efficacy and Safety of Azelaic Acid and Azelaic Acid Combined with Compound Acid in the Treatment of Post-Inflammatory Erythema and Pigmentation of Acne: A Single-center, Prospective, Randomized Controlled Clinical Study Protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097361
Enrollment
Unknown
Registered
2025-02-18
Start date
2025-02-28
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Acne

Interventions

Experimental group:35% complex acid treatment with 15% azelaic acid gel at home
Control group:Treatment with 35% complex acid excipients (excluding salicylic acid and AHAs) was performed, along with azelaic acid at home

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Patients with mild-to-moderate acne diagnosed according to the Chinese Acne Treatment Guidelines (2019 Edition) with the following facial features: (1) 20 - 50 inflammatory skin lesions (papules, pustules); (2) 30 - 100 non-inflammatory lesions (open and closed comedones); (3) No more than 2 facial nodules; IGA score is mild (2 points) or moderate (3 points); 2) Age 18 to 60 years old; 3) The patient voluntarily participates in this clinical study and signs a written informed consent form. And to comply with lifestyle precautions throughout the study: willing to use only the cleanser and moisturizer provided by this study without any medication, and not to use other acne medications, etc.; Do not use cosmetics such as foundation, barrier and makeup; Strenuous exercise should be avoided for 72 hours prior to the planned study visit.

Exclusion criteria

Exclusion criteria: 1) Facial suffering from other skin diseases, such as melasma, freckles and seborrheic dermatitis, which may affect the judgment of the test results; 2) Those who are allergic to the test product or have a highly allergic constitution; 3) Pregnant, pregnant, or lactating patients; 4) Laboratory test results of liver function and renal function are judged by doctors to be clinically significant abnormalities; 5) Patients with secondary acne, such as occupational acne and acne caused by sebaceous steroids; 6) Patients with oral antibiotics, glucocorticoids, spironolactone and other anti-androgens and other oral drugs for acne within 4 weeks before the test; or patients who have used salicylic acid, fruit acid, azelaic acid or physical therapy for acne within 2 weeks; 7) Those who took oral retinoids within 3 months before the test; 8) Facial plastic surgery, grinding, laser, injection treatment and other treatments in the 2 months before the trial; 9) Patients with immunodeficiency diseases.

Design outcomes

Primary

MeasureTime frame
Changes in PAHPI index of PIE and PIH lesions before and after treatment;

Secondary

MeasureTime frame
Lesion reduction rate = (total number of lesions before treatment - total number of lesions after treatment) / total number of lesions before treatment ×100%;Total effective rate = (number of cases of significant improvement + number of cases of regression) / total number of cases × 100%.;Investigator Global Assessement, IGA score;;Physician Global Assessment (PGA);Investigator's subjective score of erythema;Subjective score of the investigator's color pigmentation;Dermoscopy;Subject's Dermatology Life Quality Index Assessment (DLQI);Subject satisfaction evaluation;FACIAL VISIA PHOTOGRAPHED;Non-invasive skin physiological indicators: L*a*b value (melanin, heme), ITA value, skin water content, TEWL, oil detection;

Countries

China

Contacts

Public ContactXian Jiang

West China Hospital of Sichuan University

jiangxian@scu.edu.cn+86 189 8060 1693

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026