Efficacy of Long Pulsed 1064nm Laser for Facial Skin Tigh... | NCT01971736

Studies
Efficacy of Long Pulsed 1064nm Laser for Facial Skin Tightening

NCT01971736

Sponsor

Phramongkutklao College of Medicine and Hospital

Status

Completed

Last Update Posted

Oct 29, 2013Estimated

Enrollment

22Actual

Phase

Not provided

Conditions

Skin Tightening
Skin Laxity
Wrinkle Reduction

Interventions

Not provided

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

Oct 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Mar 7, 2013

First Submission Date that Met QC Criteria

Oct 23, 2013

First Posted Date

Oct 29, 2013Estimated

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

Oct 23, 2013

Last Update Posted Date

Oct 29, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

We study the efficacy of 1 pass of stacking pulses of long pulse 1064nm laser on the face for skin tightening immediately post laser and 3 months follow up.

Detailed Description

To study the efficacy on facial skin tightening and wrinkle reduction after a single pass of double stacking pulses of long pulse 1064nm laser on the face in skin types III-V immediately post procedure and at 3 months. The study is a split-face placebo-controlled single-blind study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1064nm laser, laxity		split-face single-blind randomized placebo-controlled trial evaluating improvement in facial skin laxity of the side of the face with placebo versus laser

Interventions

Not provided

Measure	Description	Time Frame
visual analog scale		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ages 35-60 years

Exclusion Criteria:

History of skin malignancy
Patients on immunosuppression
Patients with other known internal malignancy
Patients with malnutrition, vitamin or mineral insufficiency
Patients on colchicine, penicillamine
Patients with weight loss 7.5% of usual body weight within 3 months
history of botulinum toxin injection within 6 months
history of facial filler injection within 1year

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

healthy adults with visble signs of aging

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pinyapat - Kanechorn-Na-Ayuthaya, M.D.	Phramongkutklao College of Medicine and Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of dermatology, Phramongkutklao hospital		Bangkok		10400	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D003483	Cutis Laxa

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003240	Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided