A Retrospective Study on Laser Treatment of Nevus of Ota in Thai Patients

Focus on Laser Treatment of Nevus of Ota in Thai Patients Clinical Trial

Official title:

A Retrospective Study on Laser Treatment of Nevus of Ota in Thai Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04481178
• Other study ID #: si347/2020
• Status: Not yet recruiting
• Start date: September 15, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: September 2020
• Source: Mahidol University
• Contact: Prof. Woraphong Manuskiatti, M.D.
• Phone: +6624197000
• Email: woraphong.man[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective study on efficacy and complication of laser treatment (Q-switched Nd:YAG and picosecond laser) of nevus of Ota in Thai patients

Description:

Nevus of Ota is a benign dermal melanocytic nevus found most commonly in Asians. About 50-60% of all cases have the age of onset at birth or within the first year of life, others appear before puberty. It typically presents as a unilateral mottled blue-gray macules and patches distributed along the first and second branches of trigeminal nerve. Due to its marked hyperpigmentation on the face which does not resolved spontaneously, patients may experience psychosocial disturbances and often seek for treatments. Based on selective photothermolysis theory, Q-switched lasers (ruby 694nm, alexandrite 755nm, Nd:YAG 1064nm) have been used for the treatment of nevus of Ota with a success rate of 95% after 6-8 sessions. Reported complications from the lasers are hypopigmentation(15.3%), hyperpigmentation(2.9%), texture changes (2.9%), and scarring (1.9%). Siriraj Skin Laser Center provides laser treatment for nevus of Ota using mainly Q-switched Nd:YAG laser and Picosecond laser. The study of efficacy and complications of Q-switched Nd:YAG and Picosecond laser in the treatment of Nevus of Ota in Thai patients has never been reported. Therefore, we conduct a retrospective study on efficacy and complication of laser treatment (Q-switched Nd:YAG and picosecond laser) of nevus of Ota in Thai patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 79
• Est. completion date: December 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient with Nevus of Ota

• Complete data between January 2008 - December 2018

Exclusion Criteria:

• Incomplete data

Related Conditions & MeSH terms

• Focus on Laser Treatment of Nevus of Ota in Thai Patients
• Nevus
• Nevus of Ota

Intervention

Other:
• Laser (QS, Picosecond laser)
QS-Nd Yag Laser, Picosecond laser

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of laser treatment in paitients with Nevus of Ota	Fading of lesions after treatment by chart review	2008-2018
Secondary	Complication of laser such as hyperpigmentation, hypopigmentation, and scars	Complication of laser such as hyperpigmentation, hypopigmentation, and scars	2008-2018
Secondary	Relapse rate after laser treatment	rate of recurrence after treatment	2008-2018