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Efficacy and safety evaluation of azelaic acid on acne and erythema and pigmentation after inflammation

Efficacy and safety evaluation of azelaic acid on acne and erythema and pigmentation after inflammation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076959
Enrollment
Unknown
Registered
2023-10-25
Start date
2022-10-24
Completion date
Unknown
Last updated
2023-10-30

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

Conditions

Acne

Interventions

Experimental group:Azelaic acid gel
Control group:Azelaic acid free matrix

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) The facial features of patients with mild to moderate acne diagnosed according to the Chinese acne treatment guidelines (2019 version) are as follows: ? 20-50 inflammatory skin lesions (papules, pustules); ? 30-100 non-inflammatory skin lesions (open and closed acne); ? No more than 2 facial nodules; IGA score is mild (2 points) or moderate (3 points); 2) Age 18 to 60; 3) The patient voluntarily participated in the clinical study and signed the written informed consent. And during the whole study period, we should observe the lifestyle precautions: we are willing to use only the cleanser and moisturizer without any drugs provided in this study, and do not use other acne treatment drugs; Do not use foundation make-up, isolation, makeup and other cosmetics; Avoid strenuous exercise within 72 hours before the planned study visit.

Exclusion criteria

Exclusion criteria: 1) Other skin diseases on the face, such as chloasma, freckles and seborrheic dermatitis, may affect the judgment of the test results; 2) People who are allergic to the test product or have high sensitivity constitution; 3) Pregnant, expectant pregnant or lactating patients; 4) The laboratory examination results of liver function and kidney function were judged by doctors as clinically significant abnormalities; 5) Secondary acne patients, such as occupational acne and acne caused by corticosteroids; 6) Patients who take oral antibiotics, glucocorticoids, spironolactones and other anti-androgens and other acne drugs within 4 weeks before the test; Or patients who have used salicylic acid and fruit acid or physical therapy for acne within 2 weeks; 7) Those who took retinoic acid drugs orally within 2 months before the test (6 months for retinoic acid drugs); 8) Two months before the trial, there were facial plastic surgery, grinding, laser, injection therapy and other treatments; 9) Patients with immune deficiency diseases.

Design outcomes

Primary

MeasureTime frame
(Acne, papules, pustules, post-inflammatory erythema, post-inflammatory pigmentation) Lesion improvement rate;Acne investigator’s global assessment ;Subjective score of post-inflammatory erythema;Subjective score of post-inflammatory pigmentation;Satisfaction rating;Dermatological quality of life assessment;

Secondary

MeasureTime frame
Noninvasive skin physiological index detection (Skin water content, transdermal water loss rate, sebum, Lab, black and red pigment);

Countries

China

Contacts

Public ContactXian Jiang

West China Hospital, Sichuan University

jennyxianj@163.com+86 28 8542 3319

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026