NCT01971736

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2013

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

4 months

First QC Date

March 7, 2013

Last Update Submit

October 23, 2013

Conditions

Skin TighteningSkin LaxityWrinkle Reduction

Keywords

1064nm YAG laserlaxityrhytidesasian

Outcome Measures

Primary Outcomes (1)

  • visual analog scale

    3 months

Study Arms (1)

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

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy adults with visble signs of aging

You may qualify if:

  • ages 35-60 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of dermatology, Phramongkutklao hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Pinyapat - Kanechorn-Na-Ayuthaya, M.D.

    Phramongkutklao College of Medicine and Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2013

First Posted

October 29, 2013

Study Start

September 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

October 29, 2013

Record last verified: 2013-10

Locations

TH(1)