Skin TighteningNCT01971736
Efficacy of Long Pulsed 1064nm Laser for Facial Skin Tightening
An observational study of Skin Tightening and Skin Laxity, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Tightening, Skin Laxity, Wrinkle Reduction
- How many people
- 22 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2012to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy adults with visble signs of aging
Who may be able to join
- ages 35-60 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized-controlled Split-face Treatment of Facial Rhytids and Laxity in Asians Using Long-pulse 1064nm Laser
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.
Read the 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.
- Conditions
- Skin Tightening, Skin Laxity, Wrinkle Reduction
- Keywords
- 1064nm YAG laser, laxity, rhytides, asian
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startSep 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin TighteningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pinyapat - Kanechorn-Na-Ayuthaya, M.D., Principal investigator, Phramongkutklao College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971736
- Sponsor's protocol ID
- R079h/55
- Status last verified
- Oct 2013
- First submitted
- 7 Mar 2013
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized-controlled Split-face Treatment of Facial Rhytids and Laxity in Asians Using Long-pulse 1064nm Laser
- ClinicalTrials.gov ID
- NCT01971736
- Acronym / sponsor ID
- R079h/55
- Conditions
- Skin Tightening, Skin Laxity, Wrinkle Reduction
- Keywords
- 1064nm YAG laser, laxity, rhytides, asian
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy adults with visble signs of aging
Key inclusion criteria (1 listed)
- ages 35-60 years
Key exclusion criteria (8 listed)
- History of skin malignancy
- Patients on immunosuppression
- Patients with other known internal malignancy
- Patients with malnutrition, vitamin or mineral insufficiency
- Patients on colchicine, penicillamine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
visual analog scale
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pinyapat - Kanechorn-Na-Ayuthaya, M.D. principal investigator
Phramongkutklao College of Medicine and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Tightening and Skin Laxity, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2013.