The Safety and Efficacy of 1064-nm Picosecond Laser With Microlens Array for Pore Tightening; a Pilot Study

Enlarged Pores Clinical Trial

Official title:

The Safety and Efficacy of 1064-nm Picosecond Laser 1064 With Microlens Array for Pore Tightening; a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04471948
• Other study ID #: Si379/2019
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2020
• Est. completion date: March 7, 2021

Study information

• Verified date: March 2021
• Source: Mahidol University
• Contact: woraphong Manuskiatti, M.D.
• Phone: 02-419-1000
• Email: doctorlaser[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety and efficacy of 1064-nm Picosecond laser 1064 With Microlens Array for Pore tightening.

Description:

The Safety and Efficacy of Picosecond laser 1064 Nanometers With Microlens Array for Pore tightening; a Pilot Study Primary outcome : pore size Secondary outcome : side effect, patient satisfaction, global evaluation the patient recieved laser treament once a month for 3 months and then follow up after last treatment at 1, 3 ,6 month

Enlarged facial pores is one of the skin signs in photoaging. There are 3 major clinical causes of enlarged facial pores: highs sebum excretion, decreased elasticity around pores and increased hair follicle volume. Possible causative factors of enlarged facial pores include many exogenous and endogenous factors include genetic predisposition, seborrhea and chronic ultraviolet light exposure. Picosecond laser are new device which has been used in skin rejuvenation. The main mechanism of action is laser induced optical breakdown (LIOB).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: March 7, 2021
• Est. primary completion date: March 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 40 Years

Eligibility

Inclusion Criteria:

• Both male and female age 25-40 years

• No underlying disease

Exclusion Criteria:

• History of retinoid or other keratolytic drugs used within 6 months before enrolled

• History of keloid

• photosensitivity

• Immunocompromised host

Related Conditions & MeSH terms

• Enlarged Pores

Intervention

Device:
• Fractional picosecond 1064 nm laser
The parameter of laser was 8 mm spot size, 0.8 mJ/CM2, 750 ps, 5 Hz, 2 passes The treatment was done in every 4 weeks for 3 sessions.

Locations

Country	Name	City	State
Thailand	Department of Dermatology, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pore size by Antera 3D image		change from baseline in pore size at 6 months