The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae
1 other identifier
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2020
Shorter than P25 for not_applicable
1 active site
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
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 26, 2020
CompletedFirst Posted
Study publicly available on registry
July 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedJuly 2, 2020
June 1, 2020
8 months
May 26, 2020
June 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in striae roughness by Antera 3D image
change from baseline in striae roughness score at 6 months
Change in average Melanin index by Antera 3D image
change from baseline in average melanin index at 6 months
Change in melanin variation index by Antera 3D image
change from baseline in melanin variation index at 6 months
Secondary Outcomes (2)
Investigator assessment scores
Baseline, 1, 3 and 6 months after final treatment
Patient satisfaction scores
Baseline, 1, 3, and 6 months after final treatment
Study Arms (1)
Fractional Picosecond 1,064 nm laser
EXPERIMENTALThe subjects with abdominal striae alba were treated with a fractional picosecond 1,064 nm laser
Interventions
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.
Eligibility Criteria
You may qualify if:
- Striae alba on abdomen for more than 3 months
- Fitzpatrick skin type III-V
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Siriraj hospital, Mahidol University
Bangkok Noi, Bangkok, 10700, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 26, 2020
First Posted
July 2, 2020
Study Start
May 1, 2020
Primary Completion
December 30, 2020
Study Completion
December 30, 2020
Last Updated
July 2, 2020
Record last verified: 2020-06