NCT04471948

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2021

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

July 9, 2020

Last Update Submit

March 11, 2021

Conditions

Enlarged Pores

Outcome Measures

Primary Outcomes (1)

  • Change in pore size by Antera 3D image

    change from baseline in pore size at 6 months

Study Arms (1)

Fractional picosecond laser 1,064 nm laser

EXPERIMENTAL

1 arm The subjects with enlarged pores were treated with fractional picosecond laser 1,064 nm laser

Device: Fractional picosecond 1064 nm laser

Interventions

Fractional picosecond 1064 nm laserDEVICE

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.

Fractional picosecond laser 1,064 nm laser

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Both male and female age 25-40 years
  • No underlying disease

You may not qualify if:

  • History of retinoid or other keratolytic drugs used within 6 months before enrolled
  • History of keloid
  • photosensitivity
  • Immunocompromised host

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • woraphong Manuskiatti, M.D.

    Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

woraphong Manuskiatti, M.D.

CONTACT

02-419-1000doctorlaser@gmail.com

Siriwan palawisuth, M.D.

CONTACT

02-419-1000siriwan_monk@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 15, 2020

Study Start

May 7, 2020

Primary Completion

March 7, 2021

Study Completion

March 7, 2021

Last Updated

March 12, 2021

Record last verified: 2021-03

Locations

TH(1)