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Clinical study to evaluate the safety and efficacy of intradermal botulinum toxin type A injection in the treatment of melasma

Clinical study to evaluate the safety and efficacy of intradermal botulinum toxin type A injection in the treatment of melasma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080881
Enrollment
Unknown
Registered
2024-02-14
Start date
2024-02-15
Completion date
Unknown
Last updated
2024-02-19

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

Conditions

melasma

Interventions

experimental group: intradermal injection of botulinum toxin type A

Sponsors

Dermatology Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria may be considered for inclusion: 1) Symmetrical stable melasma, defined as bilateral melasma with similar appearance and position. (During non-inflammatory erythema) 2) Patients aged 18-50 years 3) Agreed to follow the experimental treatment plan and visit plan, voluntarily enrolled in the group, and signed the informed consent in person

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria are not eligible for admission: 1) Medical history/surgical history of any uncontrolled clinical systemic diseases that are serious or may affect treatment and effectiveness evaluation, such as circulatory system, nervous system, blood system, immune system, mental system diseases, etc.; 2) Significant changes in body weight during treatment (up and down 5%); 3) Receive other facial rejuvenation treatments during treatment; 4) Unprotected sun exposure during treatment; 5) Have a history of malignant tumors; 6) The patient has uncontrolled hypertension (blood pressure above 140 mmHg/90 mmHg), or a history of hypotension (blood pressure below 90 mmHg/60 mmHg); 7) Had undergone major surgery within 3 months prior to screening, or planned to undergo major surgery during the trial; 8) Participants who have participated or are participating in clinical trials of other interventional drugs or medical devices within 3 months prior to screening; 9) Received other photoelectric therapy 3 months before screening, oral tranexamic acid, glutathione, oral contraceptives, isotretinoin, minocycline and other drugs that affect melasma or have photosensitive properties 3 months before screening; 10) The investigator believes that the subjects have other conditions that may affect their compliance or are not suitable for participating in the study; 11) Prior to screening, there was a history of substance abuse, drug use or alcohol dependence

Design outcomes

Primary

MeasureTime frame
modified melasma area severity index;

Secondary

MeasureTime frame
melasma area and severity index;Melanin index;VAS;

Countries

China

Contacts

Public Contactliuzhengfeng

Dermatology Hospital of Southern Medical University

liuzhenfengpuma@163.com+86 180 1178 8797

Outcome results

None listed

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