Striae AlbaNCT04456257
The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae
A study testing fractional picosecond 1,064 nm laser in people with Striae Alba, run by Mahidol University at 1 site in Thailand.
Trial summary
The objective of this study is to evaluate the efficacy and safety of a fractional 1,064 nm picosecond laser for the treatment of striae alba. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Striae Alba
- What is being tested?
- fractional picosecond 1,064 nm laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2020to 30 Dec 2020
- Phase
- Interventional
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Striae alba on abdomen for more than 3 months
- Fitzpatrick skin type III-V
Who cannot join
- Pregnancy and breastfeeding
- Previous topical treatment, filler injection, chemical peel or laser treatment within 6 months before starting the study
- History of using Isotretinoin
- Photosensitive dermatoses, Infection, eczema
- Past history or family history of malignancy
- History of herpes infection
Show all 10Show fewer
- History of hypertrophic scar or keloid, connective tissue disease
- History of collagen or elastin disease
- History of smoking
- Significant fluctuations in weight in the past 6 months
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Siriraj hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
Woraphong Manuskiatti, M.D., +6624199922, doctorlaser@gmail.com
Arisa Kaewkes, M.D., +66895710956, searisa@yahoo.com
About this study
The objective of this study is to evaluate the efficacy and safety of a fractional 1,064 nm picosecond laser for the treatment of striae alba.
Read the detailed description
Striae distensae are atrophic dermal scars that can cause psychosocial distress on affected patients. Despite numerous available therapeutic modalities, no gold standard therapy has been established. Picosecond lasers are a newer advancement in lasers that have primarily used in the treatment of tattoos. A fractional 1064-nm picosecond laser has recently become available for the treatment of pigmentation and skin rejuvenation. The main mechanism of action is tissue ablation via laser induced optical breakdown (LIOB) which occur when pulse intensity is high enough to strip electrons and generating plasma, the plasma absorbs the remaining laser energy forming a cavitation bubble within the dermis which has been demonstrated to improve fine wrinkles and acne scar through the stimulation of collagen formation.
- Conditions
- Striae Alba
- Being tested
- fractional picosecond 1,064 nm laser
- Keywords
- striae alba, fractional picosecond laser, stretch marks
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fractional picosecond 1,064 nm laserDevice
The parameter of laser was 8-mm spot size, 0.6 mJ/cm2, 750 ps, 10 Hz, 2 passes. The treatment was done in every 4 weeks for 4 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Fractional Picosecond 1,064 nm laser | Experimental | The subjects with abdominal striae alba were treated with a fractional picosecond 1,064 nm laser Receives: Device: fractional picosecond 1,064 nm laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in striae roughness by Antera 3D image
Measured: change from baseline in striae roughness score at 6 months
Change in average Melanin index by Antera 3D image
Measured: change from baseline in average melanin index at 6 months
Change in melanin variation index by Antera 3D image
Measured: change from baseline in melanin variation index at 6 months
Secondary outcomes (2)
Investigator assessment scores
Clinical improvement was evaluated by comparing pre and post photographs by 2 independent investigators.
Measured: Baseline, 1, 3 and 6 months after final treatment
Patient satisfaction scores
patient satisfaction questionnaire was done by grading on a scale of 0 to 4; 0: no improvement, 1: <25% improvement, 2: 25-50% improvement, 3: 51-75% improvement, 4: > 75% improvement
Measured: Baseline, 1, 3, and 6 months after final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 May 2020
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Striae AlbaStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woraphong Manuskiatti, M.D., Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456257
- Sponsor's protocol ID
- Si 591/2561
- Status last verified
- Jun 2020
- First submitted
- 26 May 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae
- ClinicalTrials.gov ID
- NCT04456257
- Acronym / sponsor ID
- Si 591/2561
- Conditions
- Striae Alba
- Keywords
- striae alba, fractional picosecond laser, stretch marks
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 2 Jul 2020 (actual)
- 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.
The objective of this study is to evaluate the efficacy and safety of a fractional 1,064 nm picosecond laser for the treatment of striae alba.
Detailed description
Striae distensae are atrophic dermal scars that can cause psychosocial distress on affected patients. Despite numerous available therapeutic modalities, no gold standard therapy has been established. Picosecond lasers are a newer advancement in lasers that have primarily used in the treatment of tattoos. A fractional 1064-nm picosecond laser has recently become available for the treatment of pigmentation and skin rejuvenation. The main mechanism of action is tissue ablation via laser induced optical breakdown (LIOB) which occur when pulse intensity is high enough to strip electrons and generating plasma, the plasma absorbs the remaining laser energy forming a cavitation bubble within the dermis which has been demonstrated to improve fine wrinkles and acne scar through the stimulation of collagen formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fractional Picosecond 1,064 nm laser | Experimental | Device: fractional picosecond 1,064 nm laserThe subjects with abdominal striae alba were treated with a fractional picosecond 1,064 nm laser |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Striae alba on abdomen for more than 3 months
- Fitzpatrick skin type III-V
Key exclusion criteria (10 listed)
- Pregnancy and breastfeeding
- Previous topical treatment, filler injection, chemical peel or laser treatment within 6 months before starting the study
- History of using Isotretinoin
- Photosensitive dermatoses, Infection, eczema
- Past history or family history of malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fractional picosecond 1,064 nm laserThe parameter of laser was 8-mm spot size, 0.6 mJ/cm2, 750 ps, 10 Hz, 2 passes. The treatment was done in every 4 weeks for 4 sessions. | Device | Fractional Picosecond 1,064 nm laser |
Primary outcome
Change in striae roughness by Antera 3D image
Time frame: change from baseline in striae roughness score at 6 months
Change in average Melanin index by Antera 3D image
Time frame: change from baseline in average melanin index at 6 months
Change in melanin variation index by Antera 3D image
Time frame: change from baseline in melanin variation index at 6 months
2 secondary outcomes
Investigator assessment scores
Time frame: Baseline, 1, 3 and 6 months after final treatment
Patient satisfaction scores
Time frame: Baseline, 1, 3, and 6 months after final treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fractional picosecond 1,064 nm laser in people with Striae Alba, run by Mahidol University 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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Woraphong Manuskiatti, M.D. (+66819150555, doctorlaser@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in striae roughness by Antera 3D image (time frame: change from baseline in striae roughness score at 6 months). The study lists 3 primary outcomes in all. 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 2 Jul 2020.