The Safety and Efficacy of 1064-nm Picosecond Laser With... | NCT04471948

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

NCT04471948

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Mar 12, 2021Actual

Enrollment

26Estimated

Phase

Not Applicable

Conditions

Enlarged Pores

Interventions

Fractional picosecond 1064 nm laser

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 7, 2020Actual

Primary Completion Date

Mar 7, 2021Estimated

Completion Date

Mar 7, 2021Estimated

First Submitted Date

Jul 9, 2020

First Submission Date that Met QC Criteria

Jul 11, 2020

First Posted Date

Jul 15, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2021

Last Update Posted Date

Mar 12, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Fractional picosecond 1064 nm laser	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in pore size by Antera 3D image		change from baseline in pore size at 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
woraphong Manuskiatti, M.D.	Contact	02-419-1000		doctorlaser@gmail.com
Siriwan palawisuth, M.D.	Contact	02-419-1000		siriwan_monk@yahoo.com

Overall Officials

Name	Affiliation	Role
woraphong Manuskiatti, M.D.	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology, Siriraj Hospital, Mahidol University	Recruiting	Bangkok		10700	Thailand

Intervention Browse Module

MeSH Terms

ID	Term
D007834	Lasers

Ancestor Terms

ID	Term
D055096	Optical Devices
D004864	Equipment and Supplies
D055618	Radiation Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided