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A prospective, randomized, self-controlled clinical trial of large spot low energy picosecond laser in the treatment of Ota nevus

A prospective, randomized, self-controlled clinical trial of large spot low energy picosecond laser in the treatment of Ota nevus

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047436
Enrollment
Unknown
Registered
2021-06-18
Start date
2021-07-01
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Nevus of Ota

Interventions

Experimental group (0-3 years old/>3 years old):Big spot low fluence PSAL
Control group (0-3 years old/>3 years old):Small spot high fluence PSAL

Sponsors

Shanghai Jiao Tong University School of Medicine,Shanghai Ninth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients with nevus of Ota, aged 0 to 60 years, male/female; 2. Never underwent any relevant treatment; 3. After fully understanding the treatment plan and risks, patient or the guardian voluntarily signed the informed consent, willing to accept the self-controlled test, and cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women; 2.Allergic to topical anesthetics; 3.Any active skin disease in the test area; 4.wound infection or epidermal ulceration at the test site; 5.Other factors the researchers believe might influence the results.

Design outcomes

Primary

MeasureTime frame
pigment value;

Secondary

MeasureTime frame
satisfaction rate;

Countries

China

Contacts

Public ContactZhang Zhen

Department of Dermatology and Department of Laser and Aesthetic Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

zz6503@vip.126.com+86 13817594541

Outcome results

None listed

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