Prospective, randomized, parallel controlled clinical trial of small-spot-size, high-fluence and large-spot-size, low-fluence laser in the treatment of Café-au-lait Macules

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900027866

Enrollment

Unknown

Registered

2019-11-30

Start date

2020-02-01

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

Café-au-lait Macules

Interventions

1:Small-spot-size, high-fluence laser

2:Large-spot-size, low-fluence laser

Eligibility

Sex/Gender

All

Age

No minimum to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients that were diagnosed as Café-au-lait Macules, male or female; 2. The patient has never received other treatments for nevus of Ota; 3. The lesion of nevus of Ota is larger than 3 cm2; 4. After fully understanding the treatment plan and risk, the parents signed informed consent, willing to accept the self-control study with long-term trials, and with long-term follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with acute diseases; 2. Pregnant women or women who have plans for pregnancy; 3. Allergy to topical anesthetics; 4. The lesions were ulcer or eczema; 5. Patients who are participating in other clinical trials.

Design outcomes

Primary

Measure	Time frame
Clinical efficiency;	—

Secondary

Measure	Time frame
Clearing rate of hyperpigmentation;	—

Countries

China

Contacts

Public ContactCen Qingqing

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

cenqingqing1995@163.com+86 18817413980

Outcome results

None listed

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