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

NCT ID: NCT04471948

Last Updated: 2021-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-07

Study Completion Date

2021-03-07

Brief Summary

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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

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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).

Conditions

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Enlarged Pores

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fractional picosecond laser 1,064 nm laser

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

Group Type EXPERIMENTAL

Fractional picosecond 1064 nm laser

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Woraphong Manuskiatti, M.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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woraphong Manuskiatti, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Department of Dermatology, Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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woraphong Manuskiatti, M.D.

Role: CONTACT

02-419-1000

Siriwan palawisuth, M.D.

Role: CONTACT

02-419-1000

Facility Contacts

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Woraphong Manuskiatti, M.D.

Role: primary

081-915-0555

Siriwan Palawisuth, M.D.

Role: backup

089-022-4215

Other Identifiers

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Si379/2019

Identifier Type: -

Identifier Source: org_study_id

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